The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. GSK Medicine: GSK692342 Study Number: 113935 Title: Safety and immunogenicity of GSK Biologicals candidate tuberculosis vaccine (692342) when administered to HIV*- positive adults living in a TB* endemic region. 692342 (GSK692342, TB): GlaxoSmithKline (GSK) Biologicals candidate recombinant Mycobacterium tuberculosis (M. tuberculosis) vaccine, adjuvanted. *HIV= Human immunodeficiency virus; TB = Tuberculosis Rationale: This study, ongoing at the time of writing, is aimed at assessing the safety and immunogenicity of the TB vaccine in HIV-infected subjects aged 18-59 years. Two clusters of HIV-positive (HIV+) subjects, one on Highly Active Anti-Retroviral Therapy (HAART) and the other not on HAART, are evaluated. For comparison purposes, a further third cluster of HIVuninfected (HIV-negative [HIV-]) subjects is also evaluated. The study has an approximate duration of 3 years, and comprises two main phases, a Primary Vaccination epoch, up to Month 2, and a Follow-Up up to study end at Year 3. This summary presents results up to Year 1 of the study follow-up. It will be updated when results for later time points become available. Phase: IIB Study Period: 17 January 2011 to: - 17 July 2012 (Month 2, end of the Primary Vaccination Phase) - 17 June 2013 (up to one year post-vaccination) Study Design: Single-centre, double-blind (observer-blind), randomised, controlled study with 6 parallel groups (1:1:1:1:1:1) organised in 3 study clusters*. Centres: One centre in India Indication: Tuberculosisin HIV-infected adults aged 18 to 59 years Treatment: Study clusters and groups were as follows: Cluster: Subjects in this cluster were/are HIV-positive and receive(d) Highly Active Anti-Retroviral Therapy (HAART) therapy at the time of study enrolment. s in this cluster were: - : Subjects received 2 doses of the TB vaccine at Days 0 and 30. - : Subjects received 2 doses of saline solution at Days 0 and 30. HIV+ Treatment Naïve (TN) Cluster: Subjects in this cluster were/are HIV-positive and HAART-naïve at the time of study enrolment. s in this cluster were: - : Subjects received 2 doses of the TB vaccine at Days 0 and 30*. - : Subjects received 2 doses of saline solution at Days 0 and 30*. HIV- Cluster: Subjects in this cluster were/are HIV-negative at the time of study enrolment. s in this cluster were: - HIV- : Subjects received 2 doses of the TB vaccine at Days 0 and 30. - HIV- : Subjects received 2 doses of saline solution at Days 0 and 30. Subjects received the vaccine by intramuscular injection in the deltoid region of the arm. All doses of the TB vaccine and of the saline solution were administered intramuscularly in the deltoid region of the arm. *Since this was the first time that the TB vaccine was evaluated in HIV treatment-naïve adults, a safety review was performed in a subset of subjects at post Dose 1 before allowing progression to Dose 2 and for further vaccination of subjects in the cohort. Objectives: To evaluate the safety of the TB vaccine in adults aged 18 to 59 years, with HIV infection. Primary Outcome/Efficacy Variable: Occurrence of grade 3 solicited local and general adverse events (AEs) during the 7-day follow-up period following vaccination (day of vaccination and 6 subsequent days after each vaccine dose). Occurrence of grade 3 unsolicited AEs during the 30-day follow-up period following vaccination (day of vaccination and 29 subsequent days after each vaccine dose). Occurrence of serious adverse events (SAEs) from screening up to one month post Dose 2 in each group. Grade 3 haematological and biochemical levels at defined time points prior to vaccination (Day 0), post Dose 1 (Days 7 and 30) and post Dose 2 (Days 37 and 60). Secondary Outcome/Efficacy Variable(s):
Immunogenicity Humoral immunogenicity at defined time points - prior to Dose 1 (Day 0), post Dose 1 (Day 30) and post Dose 2 (Days 60, 210 and Years 1, 2* and 3*): - M72-specific antibody titres as measured by enzyme-linked immunosorbent assay (ELISA) - Seroconversion rates as measured by ELISA. Cell-mediated immunogenicity at defined time points - prior to Dose 1 (Day 0), post Dose 1 (Days 7 and 30) and post Dose 2 (Days 37, 60, 210 and Years 1, 2* and 3*) as defined by: - Frequency of M72-specific cluster of differentiation (CD) 4+/CD8+ T cells per 10 6 cells expressing any combination of cytokines/activation. Safety Occurrence of any solicited local and general AEs during the 7-day follow-up period following vaccination (day of vaccination and 6 subsequent days after each vaccine dose). Occurrence of any unsolicited AEs during the 30-day follow-up period following vaccination (day of vaccination and 29 subsequent days after each vaccine dose). Occurrence of SAEs from one month post Dose 2 $ up to study end in each group.* Haematological and biochemical levels at defined time points prior to vaccination (Day 0), post Dose 1 (Days 7 and 30) and post Dose 2 (Days 37 and 60). *This summary presents study results up to Year 1, of the Follow-Up Phase. It will be updated when results for later time points become available. Please refer to the Statistical Methods section below for the definition of seroconversion in this study. $ SAEs were tabulated up to one month post Dose 2 and a second tabulation was performed for covering the whole study period. Statistical Methods: The analyses were performed on the Total Vaccinated cohort and on the According-to-Protocol (ATP) cohort for immunogenicity: The Total vaccinated cohort included all vaccinated subjects for whom data were available. The ATP cohort for analysis of immunogenicity included all evaluable subjects, that is, subjects who had received at least one dose of study vaccine according to their random assignment, for whom the randomization code had not been broken, who met all eligibility criteria, complied with the procedures and intervals defined in the protocol, did not meet any of the criteria for elimination, who did not receive a product or did not present with a medical condition leading to study exclusion, and for whom data concerning immunogenicity outcome measures were available. Analysis of Immunogenicity The analysis was performed on the ATP cohort for immunogenicity. For each cluster and each group, seropositivity rates, seroconversion rates and geometric mean concentrations (GMCs) for anti-m72 antibodies, by ELISA and with 95% confidence interval (CI), were tabulated at each scheduled time point. - A seronegative/seropositive subject for M72 antibodies was defined as a subject whose concentration was below (<)/higher than or equal to ( ) the cut-off value of 2.8 EL.U/mL. - A seroconverted subject for M72 antibodies was defined as a seronegative subject at baseline with the appearance of M72 antibody concentration the cut-off value of 2.8 EL.U/mL post vaccination. Antibody concentrations below the cut-off value of the assay were given an arbitrary value of half the cut-off value for the purpose of GMC calculation. Cell-mediated immunogenicity For each cluster and each group, for each scheduled time point, descriptive statistics of the frequency of M72-specific CD4+/CD8+ T cells expressing any combinations of cytokines/activation markers amongst CD40-Ligand (CD40-L), interferon- (IFN- ), interleukin-2 (IL-2), and tumour necrosis factor- (TNF- ) after background reduction were tabulated. Analysis of Safety The percentage of subjects reporting any and grade 3 solicited local and general symptoms after each dose and across doses and during the 7-day (Days 0-6) follow-up period was tabulated with exact 95% CI by cluster and group. The same tabulation was performed for related solicited general symptoms. The percentage of subjects with clinically relevant laboratory abnormalities for haematological and biochemical parameters was tabulated by intensity grade up to Month 2 for the following parameters : haemoglobin, white blood cells, platelets, alanine aminotransferase, aspartate aminotransferase, creatinine and red blood cells. The percentage of subjects with at least one reported unsolicited AE, classified by Medical Dictionary for Regulatory Activities (MedDRA) preferred terms, was tabulated by cluster and group during the 30-day (Days 0-29) follow-up period.
The same tabulation was performed for grade 3 unsolicited AEs. The percentage of subjects with SAEs, fatal SAEs and SAEs assessed by the investigator as related to study vaccination, classified by MedDRA preferred terms, was tabulated up to Year 1. Study Population: Male or female subjects aged between, and including, 18 and 59 years at the time of the first vaccination were enrolled in the study. To be enrolled, subjects were to present clinically acceptable laboratory values at screening as determined by the investigator, to show no evidence of tuberculosis disease including no evidence of pulmonary pathology (i.e. active/acute or chronic pulmonary disease; past tuberculosis disease) as confirmed by chest X-ray and to have no history of extra pulmonary tuberculosis or of chemotherapy for tuberculosis. Subjects were excluded from enrolment if they had any history of previous administration of experimental vaccines against M. tuberculosis or of previous exposure to components of the investigational tuberculosis vaccine. Subjects with chronic administration of systemic steroids, interleukins, systemic interferon or systemic chemotherapy or with acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality were also excluded from enrolment. Female subjects of nonchildbearing potential could be enrolled in the study provided they practised adequate contraception for 30 days prior to vaccination, had a negative pregnancy test on the day of vaccination, and agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Written informed consent was obtained from subjects prior to any study procedure. In addition, the following additional criteria were also applied, depending on the cluster in which the subject was enrolled: Cluster: To be enrolled in this cluster, subjects were to be HIV-positive, to have been under care of a physician for at least 6 months, to have a CD4+T cell count higher than or equal to ( ) 250 cells/mm 3 at screening and to have been stable on HAART for at least 6 months, with an undetectable HIV viral load level (< 400 copies/ml) at screening. Subjects were excluded from enrolment in this cluster if they presented any change in anti-retroviral drug regimen within 12 weeks prior to screening and in case of any chronic drug therapy to be continued during the study period other than, HAART or prophylaxis for opportunistic HIV related infections and/or HIV-related symptoms, birth control pills, anti-histamines for seasonal allergies and selective serotonin-reuptake inhibitors. Cluster: To be enrolled in this cluster, subjects were to be HIV-positive, to have been under care of a physician for at least 6 months, to be HAART-naïve (e. a. to have never received anti-retrovirals after HIV diagnosis), to have a CD4+ T cell count above 350 cells/mm 3 at screening, not to be expected to start HAART treatment within the next year and to have a viral load between 5000-80000 copies/ml at screening. HIV- Cluster: To be enrolled in this cluster, subjects were to be negative for HIV-1. Number of Subjects: Cluster Cluster HIV- Cluster HIV- HIV- Planned, N 40 40 40 40 40 40 Randomised, N (Total Vaccinated cohort) 40 40 40 40 40 40 Completed to Month 2, n (%) 37 (92.5) 39 (97.5) 39 (97.5) 38 (95.0) 38 (95.0) 36 (90.0) Completed to Month 7, n (%) 35 (87.5) 40 (100) 34 (85.0) 34 (85.0) 38 (95.0) 36 (90.0) Completed to Year 1, n (%) 31 (77.5) 39 (97.5) 37 (92.5) 36 (90.0) 29 (72.5) 31 (77.5) Number of subjects with unknown status, 4 (10.0) 0 (0.0) 1 (2.5) 2 (5.0) 1 (2.5) 3 (7.5) n(%) Total Number Subjects Withdrawn, n (%) 5 (12.5) 1 (2.5) 2 (5.0) 2 (5.0) 10 (25.0) 6 (15.0) Withdrawn due to Adverse Events n (%) 0 (0.0) 0 (0.0) 2 (5.0) 0 (0.0) 0 (0.0) 0 (0.0) Withdrawn due to Lack of Efficacy n (%) Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Withdrawn for other reasons n (%) 5 (12.5) 1 (2.5) 0 (0.0) 2 (5.0) 10 (25.0) 6 (15.0) Demographics Cluster Cluster HIV- Cluster HIV- HIV- N (Total Vaccinated cohort) 40 40 40 40 40 40 Sex, n (%) Females 27 (67.5) 26 (65.0) 29 (72.5) 28 (70.0) 30 (75.0) 27 (67.5) Males 13 (32.5) 14 (35.0) 11 (27.5) 12 (30.0) 10 (25.0) 13 (32.5) Mean Age, years (SD) 36.0 (6.46) 35.5 (6.19) 32.6 (6.50) 32.2 (5.34) 33.9 (7.55) 34.6 (6.45) Median 35.0 35.0 30.5 32.0 33.0 35.0 Minimum 25 19 23 22 19 24 Maximum 53 46 50 45 53 50
Asian - Central/South Asian heritage, n 40 (100) 40 (100) 38 (95.0) 36 (90.0) 38 (95.0) 39 (97.5) (%) Asian - East Asian heritage, n (%) - - - 1 (2.5) - - Asian - South East Asian heritage, n (%) - - 2 (5.0) 3 (7.5) 2 (5.0) 1 (2.5) Primary Efficacy Results: Number (percentage) of subjects with solicited local symptoms reported during the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses (Total Vaccinated cohort) Cluster Cluster Symptom Intensity 95 % CI 95 % CI 95 % CI N n % LL UL N n % LL UL N n % LL UL Dose 1 Pain Any 40 12 30.0 16.6 46.5 40 7 17.5 7.3 32.8 40 6 15.0 5.7 29.8 Grade 3* 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 Swelling Any 40 3 7.5 1.6 20.4 40 1 2.5 0.1 13.2 40 2 5.0 0.6 16.9 > 50 mm* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Dose 2 Pain Any 39 10 25.6 13.0 42.1 39 5 12.8 4.3 27.4 40 5 12.5 4.2 26.8 Grade 3* 39 3 7.7 1.6 20.9 39 0 0.0 0.0 9.0 40 2 5.0 0.6 16.9 Swelling Any 39 4 10.3 2.9 24.2 39 0 0.0 0.0 9.0 40 2 5.0 0.6 16.9 > 50 mm* 39 0 0.0 0.0 9.0 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Across Doses Pain Any 40 14 35.0 20.6 51.7 40 7 17.5 7.3 32.8 40 8 20.0 9.1 35.6 Grade 3* 40 3 7.5 1.6 20.4 40 0 0.0 0.0 8.8 40 3 7.5 1.6 20.4 Swelling Any 40 5 12.5 4.2 26.8 40 1 2.5 0.1 13.2 40 4 10.0 2.8 23.7 > 50 mm* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Cluster HIV- Cluster HIV- HIV- Symptom Intensity 95 % CI 95 % CI 95 % CI N n % LL UL N n % LL UL N n % LL UL Dose 1 Pain Any 40 3 7.5 1.6 20.4 40 8 20.0 9.1 35.6 40 3 7.5 1.6 20.4 Grade 3* 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 Swelling Any 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 > 50 mm* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Dose 2 Pain Any 40 2 5.0 0.6 16.9 39 7 17.9 7.5 33.5 37 0 0.0 0.0 9.5 Grade 3* 40 0 0.0 0.0 8.8 39 4 10.3 2.9 24.2 37 0 0.0 0.0 9.5 Swelling Any 40 0 0.0 0.0 8.8 39 4 10.3 2.9 24.2 37 0 0.0 0.0 9.5 > 50 mm* 40 0 0.0 0.0 8.8 39 0 0.0 0.0 9.0 37 0 0.0 0.0 9.5 Across Doses Pain Any 40 3 7.5 1.6 20.4 40 9 22.5 10.8 38.5 40 3 7.5 1.6 20.4 Grade 3* 40 0 0.0 0.0 8.8 40 4 10.0 2.8 23.7 40 0 0.0 0.0 8.8 Swelling Any 40 0 0.0 0.0 8.8 40 4 10.0 2.8 23.7 40 0 0.0 0.0 8.8 > 50 mm* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 N= number of subjects with at least one documented dose n/%= number/percentage of subjects reporting the symptom at least once 95% CI = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = Incidence of any particular symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal activity *Primary Outcome Variable. Primary Efficacy Results: Number (percentage) of subjects with solicited general symptoms reported during the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses (Total Vaccinated cohort) Cluster Cluster Symptom Intensity/Relationship 95 % CI 95 % CI 95 % CI N n % LL UL N n % LL UL N n % LL UL
Dose 1 Fatigue Any 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Gastrointestinal symptoms Any 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Headache Any 40 2 5.0 0.6 16.9 40 3 7.5 1.6 20.4 40 3 7.5 1.6 20.4 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 Malaise Any 40 2 5.0 0.6 16.9 40 1 2.5 0.1 13.2 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Myalgia Any 40 4 10.0 2.8 23.7 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Temperature (Axillary route) Any 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 2 5.0 0.6 16.9 Related 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 1 2.5 0.1 13.2 > 39.5 C* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Dose 2 Fatigue Any 39 2 5.1 0.6 17.3 39 1 2.6 0.1 13.5 40 1 2.5 0.1 13.2 Related 39 0 0.0 0.0 9.0 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Grade 3* 39 1 2.6 0.1 13.5 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Gastrointestinal symptoms Any 39 1 2.6 0.1 13.5 39 0 0.0 0.0 9.0 40 1 2.5 0.1 13.2 Related 39 0 0.0 0.0 9.0 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Grade 3* 39 0 0.0 0.0 9.0 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Headache Any 39 4 10.3 2.9 24.2 39 2 5.1 0.6 17.3 40 2 5.0 0.6 16.9 Related 39 0 0.0 0.0 9.0 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Grade 3* 39 2 5.1 0.6 17.3 39 0 0.0 0.0 9.0 40 1 2.5 0.1 13.2 Malaise Any 39 2 5.1 0.6 17.3 39 1 2.6 0.1 13.5 40 1 2.5 0.1 13.2 Related 39 0 0.0 0.0 9.0 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Grade 3* 39 2 5.1 0.6 17.3 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Myalgia Any 39 3 7.7 1.6 20.9 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Related 39 0 0.0 0.0 9.0 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Grade 3* 39 1 2.6 0.1 13.5 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Temperature (Axillary route) Any 39 5 12.8 4.3 27.4 39 0 0.0 0.0 9.0 40 4 10.0 2.8 23.7 Related 39 3 7.7 1.6 20.9 39 0 0.0 0.0 9.0 40 4 10.0 2.8 23.7 > 39.5 C* 39 0 0.0 0.0 9.0 39 0 0.0 0.0 9.0 40 0 0.0 0.0 8.8 Across Doses Fatigue Any 40 2 5.0 0.6 16.9 40 1 2.5 0.1 13.2 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Gastrointestinal symptoms Any 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Headache Any 40 4 10.0 2.8 23.7 40 3 7.5 1.6 20.4 40 4 10.0 2.8 23.7 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 2 5.0 0.6 16.9 40 1 2.5 0.1 13.2 40 1 2.5 0.1 13.2 Malaise Any 40 2 5.0 0.6 16.9 40 2 5.0 0.6 16.9 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Myalgia Any 40 4 10.0 2.8 23.7 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Temperature (Axillary route) Any 40 5 12.5 4.2 26.8 40 1 2.5 0.1 13.2 40 6 15.0 5.7 29.8 Related 40 3 7.5 1.6 20.4 40 1 2.5 0.1 13.2 40 5 12.5 4.2 26.8
> 39.5 C* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Cluster HIV- Cluster HIV- HIV- Symptom Intensity/Relationship 95 % CI 95 % CI 95 % CI N n % LL UL N n % LL UL N n % LL UL Fatigue Any 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 Gastrointestinal symptoms Any 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 Headache Any 40 1 2.5 0.1 13.2 40 4 10.0 2.8 23.7 40 2 5.0 0.6 16.9 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 3 7.5 1.6 20.4 40 0 0.0 0.0 8.8 Malaise Any 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 Myalgia Any 40 0 0.0 0.0 8.8 40 3 7.5 1.6 20.4 40 0 0.0 0.0 8.8 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 Temperature (Axillary route) Any 40 2 5.0 0.6 16.9 40 3 7.5 1.6 20.4 40 0 0.0 0.0 8.8 Related 40 1 2.5 0.1 13.2 40 3 7.5 1.6 20.4 40 0 0.0 0.0 8.8 > 39.5 C* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Dose 2 Fatigue Any 40 1 2.5 0.1 13.2 39 1 2.6 0.1 13.5 37 0 0.0 0.0 9.5 Related 40 0 0.0 0.0 8.8 39 0 0.0 0.0 9.0 37 0 0.0 0.0 9.5 Grade 3* 40 0 0.0 0.0 8.8 39 1 2.6 0.1 13.5 37 0 0.0 0.0 9.5 Gastrointestinal symptoms Any 40 0 0.0 0.0 8.8 39 0 0.0 0.0 9.0 37 0 0.0 0.0 9.5 Related 40 0 0.0 0.0 8.8 39 0 0.0 0.0 9.0 37 0 0.0 0.0 9.5 Grade 3* 40 0 0.0 0.0 8.8 39 0 0.0 0.0 9.0 37 0 0.0 0.0 9.5 Headache Any 40 1 2.5 0.1 13.2 39 8 20.5 9.3 36.5 37 0 0.0 0.0 9.5 Related 40 0 0.0 0.0 8.8 39 1 2.6 0.1 13.5 37 0 0.0 0.0 9.5 Grade 3* 40 0 0.0 0.0 8.8 39 4 10.3 2.9 24.2 37 0 0.0 0.0 9.5 Malaise Any 40 0 0.0 0.0 8.8 39 1 2.6 0.1 13.5 37 0 0.0 0.0 9.5 Related 40 0 0.0 0.0 8.8 39 0 0.0 0.0 9.0 37 0 0.0 0.0 9.5 Grade 3* 40 0 0.0 0.0 8.8 39 1 2.6 0.1 13.5 37 0 0.0 0.0 9.5 Myalgia Any 40 0 0.0 0.0 8.8 39 3 7.7 1.6 20.9 37 1 2.7 0.1 14.2 Related 40 0 0.0 0.0 8.8 39 1 2.6 0.1 13.5 37 0 0.0 0.0 9.5 Grade 3* 40 0 0.0 0.0 8.8 39 1 2.6 0.1 13.5 37 0 0.0 0.0 9.5 Temperature (Axillary route) Any 40 1 2.5 0.1 13.2 39 9 23.1 11.1 39.3 37 1 2.7 0.1 14.2 Related 40 1 2.5 0.1 13.2 39 6 15.4 5.9 30.5 37 1 2.7 0.1 14.2 > 39.5 C* 40 0 0.0 0.0 8.8 39 0 0.0 0.0 9.0 37 0 0.0 0.0 9.5 Across Doses Fatigue Any 40 1 2.5 0.1 13.2 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 Gastrointestinal symptoms Any 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 Headache Any 40 2 5.0 0.6 16.9 40 8 20.0 9.1 35.6 40 2 5.0 0.6 16.9 Related 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 5 12.5 4.2 26.8 40 0 0.0 0.0 8.8 Malaise Any 40 0 0.0 0.0 8.8 40 2 5.0 0.6 16.9 40 0 0.0 0.0 8.8 Related 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8
Myalgia Any 40 0 0.0 0.0 8.8 40 3 7.5 1.6 20.4 40 1 2.5 0.1 13.2 Related 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 Grade 3* 40 0 0.0 0.0 8.8 40 1 2.5 0.1 13.2 40 0 0.0 0.0 8.8 Temperature (Axillary route) Any 40 3 7.5 1.6 20.4 40 9 22.5 10.8 38.5 40 1 2.5 0.1 13.2 Related 40 2 5.0 0.6 16.9 40 7 17.5 7.3 32.8 40 1 2.5 0.1 13.2 > 39.5 C* 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 40 0 0.0 0.0 8.8 N = number of subjects with at least one documented dose n/% = number/percentage of subjects reporting the symptom at least once 95% CI = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = Incidence of any particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = Incidence of a particular symptom that prevented normal activity Gastrointestinal symptoms included nausea, vomiting and/or abdominal pain. *Primary Outcome Variable. Primary Efficacy Results: Number and percentage of subjects outside the Normal ranges and at the different grades of severity for haematology biochemistry (Total Vaccinated cohort) Cluster Cluster HIV- Clusters HIV- HIV- Laboratory test Timing Categories N % n % n % n % n % n % Haemoglobin PRE 1. Normal 28 70.0 25 62.5 19 47.5 25 62.5 23 57.5 22 55.0 2. Grade 1 6 15.0 11 27.5 9 22.5 3 7.5 10 25.0 13 32.5 3. Grade 2 3 7.5 3 7.5 9 22.5 9 22.5 5 12.5 3 7.5 4. Grade 3* 1 2.5 1 2.5 2 5.0 3 7.5 2 5.0 2 5.0 5. Grade 4* 2 5.0 0 0.0 1 2.5 0 0.0 0 0.0 0 0.0 PI(D7) 1. Normal 27 67.5 24 60.0 19 47.5 21 53.8 22 56.4 22 55.0 2. Grade 1 7 17.5 11 27.5 11 27.5 7 17.9 9 23.1 11 27.5 3. Grade 2 3 7.5 5 12.5 7 17.5 9 23.1 5 12.8 5 12.5 4. Grade 3* 1 2.5 0 0.0 2 5.0 1 2.6 3 7.7 2 5.0 5. Grade 4* 2 5.0 0 0.0 1 2.5 1 2.6 0 0.0 0 0.0 PI(M1) 1. Normal 23 59.0 22 55.0 17 42.5 22 55.0 21 53.8 22 57.9 2. Grade 1 9 23.1 15 37.5 10 25.0 7 17.5 10 25.6 12 31.6 3. Grade 2 4 10.3 3 7.5 10 25.0 9 22.5 7 17.9 2 5.3 4. Grade 3* 2 5.1 0 0.0 3 7.5 2 5.0 1 2.6 2 5.3 5. Grade 4* 1 2.6 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PII(D37) 1. Normal 22 57.9 24 61.5 16 41.0 17 43.6 20 51.3 21 56.8 2. Grade 1 9 23.7 12 30.8 12 30.8 12 30.8 12 30.8 10 27.0 3. Grade 2 4 10.5 2 5.1 9 23.1 8 20.5 5 12.8 4 10.8 4. Grade 3* 2 5.3 1 2.6 2 5.1 2 5.1 2 5.1 1 2.7 5. Grade 4* 1 2.6 0 0.0 0 0.0 0 0.0 0 0.0 1 2.7 Missing 0-0 - 0-1 - 0-0 - PII(M2) 1. Normal 24 64.9 25 64.1 17 43.6 21 55.3 22 57.9 21 60.0 2. Grade 1 9 24.3 10 25.6 13 33.3 9 23.7 9 23.7 10 28.6 3. Grade 2 2 5.4 4 10.3 6 15.4 7 18.4 5 13.2 2 5.7 4. Grade 3* 2 5.4 0 0.0 3 7.7 1 2.6 2 5.3 1 2.9 5. Grade 4* 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 1 2.9 White Blood Cells PRE 1. Normal 39 97.5 36 90.0 38 95.0 37 92.5 35 87.5 36 90.0 2. Grade 1 1 2.5 4 10.0 2 5.0 3 7.5 4 10.0 4 10.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 1 2.5 0 0.0 PI(D7) 1. Normal 37 92.5 38 95.0 38 95.0 37 94.9 36 92.3 37 92.5 2. Grade 1 3 7.5 2 5.0 2 5.0 2 5.1 3 7.7 3 7.5 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0
PI(M1) 1. Normal 34 87.2 39 97.5 38 95.0 40 100 39 100 34 89.5 2. Grade 1 3 7.7 1 2.5 2 5.0 0 0.0 0 0.0 2 5.3 3. Grade 2 1 2.6 0 0.0 0 0.0 0 0.0 0 0.0 2 5.3 5. Grade 4* 1 2.6 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PII(D37) 1. Normal 31 81.6 35 89.7 38 97.4 35 89.7 35 89.7 32 86.5 2. Grade 1 7 18.4 4 10.3 0 0.0 4 10.3 4 10.3 4 10.8 3. Grade 2 0 0.0 0 0.0 1 2.6 0 0.0 0 0.0 1 2.7 Missing 0-0 - 0-1 - 0-0 - PII(M2) 1. Normal 33 89.2 37 94.9 37 94.9 35 92.1 34 89.5 29 82.9 2. Grade 1 4 10.8 2 5.1 2 5.1 3 7.9 4 10.5 5 14.3 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 1 2.9 Platelets PRE 1. Normal 40 100 39 97.5 38 95.0 40 100 40 100 40 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 0 0.0 1 2.5 0 0.0 0 0.0 0 0.0 4. Grade 3* 0 0.0 1 2.5 0 0.0 0 0.0 0 0.0 0 0.0 5. Grade 4* 0 0.0 0 0.0 1 2.5 0 0.0 0 0.0 0 0.0 PI(D7) 1. Normal 40 100 39 97.5 39 97.5 39 100 39 100 40 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 4. Grade 3* 0 0.0 1 2.5 0 0.0 0 0.0 0 0.0 0 0.0 5. Grade 4* 0 0.0 0 0.0 1 2.5 0 0.0 0 0.0 0 0.0 PI(M1) 1. Normal 39 100 40 100 39 97.5 40 100 39 100 38 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 5. Grade 4* 0 0.0 0 0.0 1 2.5 0 0.0 0 0.0 0 0.0 PII(D37) 1. Normal 38 100 38 97.4 38 97.4 39 100 38 97.4 37 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 1 2.6 0 0.0 0 0.0 0 0.0 0 0.0 4. Grade 3* 0 0.0 0 0.0 1 2.6 0 0.0 0 0.0 0 0.0 5. Grade 4* 0 0.0 0 0.0 0 0.0 0 0.0 1 2.6 0 0.0 Missing 0-0 - 0-1 - 0-0 - PII(M2) 1. Normal 37 100 38 97.4 38 97.4 38 100 38 100 35 100 2. Grade 1 0 0.0 1 2.6 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 5. Grade 4* 0 0.0 0 0.0 1 2.6 0 0.0 0 0.0 0 0.0 ALAT PRE 1. Normal 32 80.0 33 82.5 37 92.5 31 77.5 37 92.5 36 90.0 2. Grade 1 7 17.5 7 17.5 3 7.5 9 22.5 3 7.5 4 10.0 3. Grade 2 1 2.5 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PI(D7) 1. Normal 30 75.0 32 80.0 32 80.0 33 84.6 34 87.2 35 87.5 2. Grade 1 9 22.5 7 17.5 7 17.5 6 15.4 5 12.8 5 12.5 3. Grade 2 1 2.5 1 2.5 1 2.5 0 0.0 0 0.0 0 0.0 PI(M1) 1. Normal 30 76.9 31 77.5 34 85.0 34 85.0 36 92.3 35 92.1 2. Grade 1 9 23.1 9 22.5 6 15.0 5 12.5 3 7.7 3 7.9 3. Grade 2 0 0.0 0 0.0 0 0.0 1 2.5 0 0.0 0 0.0
PII(D37) 1. Normal 28 73.7 31 79.5 34 87.2 35 87.5 33 84.6 35 94.6 2. Grade 1 9 23.7 8 20.5 4 10.3 5 12.5 6 15.4 2 5.4 3. Grade 2 1 2.6 0 0.0 1 2.6 0 0.0 0 0.0 0 0.0 PII(M2) 1. Normal 27 73.0 31 79.5 34 87.2 32 84.2 33 86.8 32 91.4 2. Grade 1 9 24.3 8 20.5 5 12.8 6 15.8 5 13.2 3 8.6 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 4. Grade 3* 1 2.7 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 ASAT PRE 1. Normal 30 75.0 30 75.0 28 70.0 29 72.5 33 82.5 38 95.0 2. Grade 1 9 22.5 10 25.0 12 30.0 11 27.5 6 15.0 2 5.0 3. Grade 2 1 2.5 0 0.0 0 0.0 0 0.0 1 2.5 0 0.0 PI(D7) 1. Normal 31 77.5 29 72.5 30 75.0 27 69.2 31 79.5 33 82.5 2. Grade 1 8 20.0 11 27.5 9 22.5 12 30.8 7 17.9 7 17.5 3. Grade 2 1 2.5 0 0.0 1 2.5 0 0.0 1 2.6 0 0.0 PI(M1) 1. Normal 29 74.4 30 75.0 32 80.0 29 72.5 33 84.6 33 86.8 2. Grade 1 9 23.1 10 25.0 8 20.0 10 25.0 5 12.8 5 13.2 3. Grade 2 1 2.6 0 0.0 0 0.0 1 2.5 1 2.6 0 0.0 PII(D37) 1. Normal 29 76.3 29 74.4 29 74.4 26 65.0 34 87.2 33 89.2 2. Grade 1 8 21.1 10 25.6 10 25.6 14 35.0 4 10.3 4 10.8 3. Grade 2 1 2.6 0 0.0 0 0.0 0 0.0 1 2.6 0 0.0 PII(M2) 1. Normal 27 73.0 29 74.4 25 64.1 24 63.2 32 84.2 29 82.9 2. Grade 1 9 24.3 9 23.1 14 35.9 14 36.8 5 13.2 6 17.1 3. Grade 2 0 0.0 1 2.6 0 0.0 0 0.0 1 2.6 0 0.0 4. Grade 3* 1 2.7 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 Creatinine PRE 1. Normal 39 97.5 40 100 40 100 40 100 40 100 40 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 4. Grade 3* 1 2.5 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PI(D7) 1. Normal 39 97.5 40 100 40 100 39 100 38 97.4 40 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 1 2.6 0 0.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 4. Grade 3* 1 2.5 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PI(M1) 1. Normal 38 97.4 40 100 40 100 40 100 39 100 38 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 4. Grade 3* 1 2.6 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PII(D37) 1. Normal 37 97.4 39 100 39 100 40 100 39 100 37 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 4. Grade 3* 1 2.6 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0
PII(M2) 1. Normal 36 97.3 39 100 39 100 38 100 38 100 35 100 2. Grade 1 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 4. Grade 3* 1 2.7 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 Red Blood Cells PRE 1. Normal 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 2. Grade 1 40 100 40 100 40 100 40 100 40 100 40 100 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PI(D7) 1. Normal 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 2. Grade 1 40 100 40 100 40 100 39 100 39 100 40 100 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PI(M1) 1. Normal 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 2. Grade 1 39 100 40 100 40 100 40 100 39 100 38 100 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 PII(D37) 1. Normal 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 2. Grade 1 38 100 39 100 39 100 39 100 39 100 37 100 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 Missing 0-0 - 0-1 - 0-0 - PII(M2) 1. Normal 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 2. Grade 1 37 100 39 100 39 100 38 100 38 100 35 100 3. Grade 2 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 N = number of subjects n = number of subjects in a given category % = n / Number of subjects with available results x 100 ALAT = Alanine aminoransferase ASAT = Aspartate aminoransferase PRE = Pre-vaccination, at Day 0 PI(D7) = Post Dose 1, at Day 7 PI(M1) = Post Dose 1, at Day 30 PII(D37) = Post Dose 2, at Day 37 PII(M2) = Post Dose 2, at Day 60 *Primary Outcome Variable Primary Efficacy Results: Please refer to the Safety Results Section of this summary for Unsolicited AEs and SAEs results. Secondary Outcome Results: Seropositivity rates and GMCs for anti-m72 antibodies measured by ELISA (ATP cohort for immunogenicity) 2.8 EU/ml GMC (EU/ml) 95% CI 95% CI Antibody Cluster Timing N n % LL UL value LL UL anti-m72 antibody PRE 39 0 0.0 0.0 9.0 1.4 1.4 1.4 PI(M1) 36 23 63.9 46.2 79.2 4.9 3.2 7.5 PII(M2) 37 36 97.3 85.8 99.9 469.3 310.8 708.5 PII(M7) 35 34 97.1 85.1 99.9 45.5 31.4 66.0 PII(M13) 31 30 96.8 83.3 99.9 28.0 18.8 41.6 PRE 39 0 0.0 0.0 9.0 1.4 1.4 1.4 PI(M1) 39 0 0.0 0.0 9.0 1.4 1.4 1.4 PII(M2) 38 1 2.6 0.1 13.8 1.5 1.3 1.6
PII(M7) 39 0 0.0 0.0 9.0 1.4 1.4 1.4 PII(M13) 38 0 0.0 0.0 9.3 1.4 1.4 1.4 PRE 39 1 2.6 0.1 13.5 1.5 1.3 1.6 PI(M1) 39 27 69.2 52.4 83.0 6.0 4.0 9.2 PII(M2) 38 37 97.4 86.2 99.9 249.4 142.3 437.2 PII(M7) 33 29 87.9 71.8 96.6 17.7 11.0 28.5 PII(M13) 36 29 80.6 64.0 91.8 9.3 6.3 13.8 PRE 37 0 0.0 0.0 9.5 1.4 1.4 1.4 PI(M1) 38 0 0.0 0.0 9.3 1.4 1.4 1.4 PII(M2) 38 0 0.0 0.0 9.3 1.4 1.4 1.4 PII(M7) 33 0 0.0 0.0 10.6 1.4 1.4 1.4 PII(M13) 36 0 0.0 0.0 9.7 1.4 1.4 1.4 HIV- HIV- PRE 39 0 0.0 0.0 9.0 1.4 1.4 1.4 PI(M1) 38 35 92.1 78.6 98.3 11.2 7.5 16.7 PII(M2) 36 36 100 90.3 100 754.5 532.6 1068.9 PII(M7) 37 36 97.3 85.8 99.9 58.3 42.2 80.6 PII(M13) 28 27 96.4 81.7 99.9 29.4 20.7 41.8 HIV- PRE 39 2 5.1 0.6 17.3 1.5 1.4 1.6 PI(M1) 38 1 2.6 0.1 13.8 1.5 1.3 1.8 PII(M2) 35 1 2.9 0.1 14.9 1.5 1.3 1.8 PII(M7) 35 2 5.7 0.7 19.2 1.5 1.3 1.7 PII(M13) 31 1 3.2 0.1 16.7 1.5 1.3 1.6 GMC = geometric mean antibody concentration calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination PI(M1) = Post Dose 1 (Day 30) PII(M2) = Post Dose 2 (Day 60) PII(M7) = Post Dose 2 (Month 7) PII(M13) = Post Dose 2 (Month 13) Secondary Outcome Results: Descriptive Statistics for the frequency of M72-specific CD4+ T-cells expressing at least 2 immune markers among IL-2, IFN-, TNF- and CD40-L after background reduction (ATP cohort for immunogenicity) Immune marker Cluster Timing N Nmiss Mean SD Min Q1 Median Q3 Max CD4-All PRE 34 5 550.59 1543.39 37 110.0 176.5 306.0 9060 doubles PI(D7) 33 6 3297.61 3814.98 22 545.0 1253.0 6993.0 12847 PI(M1) 31 7 2551.52 3408.78 41 992.0 1661.0 2258.0 15697 PII(D37) 27 10 10899.41 6793.81 66 6906.0 9060.0 15368.0 33534 PII(M2) 23 14 7823.70 5810.08 40 3151.0 7505.0 9705.0 21073 PII(M7) 31 4 3725.65 2212.70 416 2035.0 3488.0 5140.0 10453 PII(M13) 29 2 4145.45 3573.30 88 2224.0 3593.0 4827.0 18490 PRE 36 3 1154.50 3699.13 41 127.0 279.5 519.0 22058 PI(D7) 32 7 686.00 1084.79 75 198.0 278.0 622.5 5295 PI(M1) 37 2 1295.43 4156.09 47 143.0 306.0 621.0 24729 PII(D37) 31 6 449.94 536.89 21 138.0 210.0 512.0 2024 PII(M2) 26 12 1088.31 3641.04 32 111.0 230.5 410.0 18687 PII(M7) 32 7 455.63 383.04 11 226.0 346.0 579.5 1835 PII(M13) 35 3 461.11 418.48 62 228.0 373.0 470.0 2211 PRE 32 7 241.56 271.72 11 63.0 173.0 300.5 1348 PI(D7) 31 8 1912.45 2659.23 53 223.0 693.0 2147.0 10872 PI(M1) 31 8 1354.68 1633.05 106 312.0 610.0 1654.0 6159 PII(D37) 32 6 7139.19 6747.34 219 2033.0 5346.5 9841.5 27052 PII(M2) 26 12 3492.19 3421.22 481 1618.0 2283.5 4368.0 17149 PII(M7) 30 3 1711.40 2216.94 175 502.0 1084.5 1777.0 11128 PII(M13) 31 5 1412.35 2022.86 11 431.0 863.0 1572.0 9709
PRE 31 7 730.68 2892.05 25 82.0 145.0 317.0 16275 PI(D7) 32 6 722.47 2834.37 11 89.5 168.5 314.5 16222 PI(M1) 33 5 439.24 1429.23 11 71.0 163.0 265.0 8335 PII(D37) 33 5 157.94 133.16 11 55.0 94.0 243.0 617 PII(M2) 30 8 174.50 102.36 38 91.0 148.5 244.0 406 PII(M7) 31 2 299.13 384.99 11 109.0 189.0 358.0 2137 PII(M13) 32 4 363.78 766.04 23 81.5 191.5 328.0 4393 HIV- HIV- PRE 32 7 355.59 498.52 42 121.0 216.5 381.0 2736 PI(D7) 35 3 4115.26 5422.17 51 581.0 2352.0 5353.0 25188 PI(M1) 21 17 2357.67 2283.82 190 1021.0 1499.0 2889.0 8135 PII(D37) 21 17 9133.38 8794.04 1244 4217.0 5705.0 10980.0 37542 PII(M2) 32 5 3429.72 2945.40 284 1701.5 2913.0 4113.0 16171 PII(M7) 30 7 1802.33 906.31 334 1166.0 1630.5 2400.0 4696 PII(M13) 26 2 1824.08 1958.12 211 885.0 1181.0 1943.0 10306 HIV- PRE 28 11 425.54 459.60 47 122.0 290.0 489.0 1841 PI(D7) 33 6 558.15 667.66 29 93.0 274.0 770.0 2600 PI(M1) 20 18 442.75 479.62 67 147.0 312.0 524.5 2024 PII(D37) 22 15 551.41 876.74 67 158.0 204.5 405.0 3911 PII(M2) 28 7 446.82 720.37 29 149.0 229.5 514.0 3879 PII(M7) 31 4 373.61 330.90 24 140.0 287.0 586.0 1502 PII(M13) 28 3 334.04 301.18 39 141.0 274.0 447.5 1501 N = number of subjects with available results Nmiss = number of subjects with missing results SD = Standard Deviation Q1,Q3 = First and third quartiles Min/Max = Minimum/Maximum PRE = Pre-vaccination, at Day 0 PI(D7) = Post Dose 1, at Day 7 PI(M1) = Post Dose 1, at Day 30 PII(D37) = Post Dose 2, at Day 37 PII(M2) = Post Dose 2, at Day 60 PII(M7) = Post Dose 2 at Month 7 PII(M13) = Post Dose 2 at Month 13 Secondary Outcome Results: Descriptive Statistics of the frequency of M72 specific CD4+ T cells expressing any combination of cytokines among CD40-L, IFN-, IL-2 and TNF- after background reduction (ATP cohort for immunogenicity) Immune Cluster Timing N Nmiss Mean SD Min Q1 Median Q3 Max marker CD4.CD40L(+) +IL2(+)+TNF- (+)+IFN- (+) PRE 34 5 101.91 119.36 1 15.0 58.5 132.0 447 PI(D7) 33 6 1592.12 2176.78 1 153.0 525.0 1759.0 8809 PI(M1) 31 7 517.58 628.80 1 133.0 307.0 792.0 3319 PII(D37) 27 10 2333.96 1734.27 1 1000.0 2229.0 3539.0 7707 PII(M2) 23 14 1438.35 1155.33 1 428.0 1257.0 2169.0 4077 PII(M7) 31 4 1017.55 710.10 77 435.0 967.0 1310.0 2770 PII(M13) 29 2 1046.62 800.87 1 412.0 798.0 1586.0 2904 PRE 36 3 154.53 172.80 1 30.5 86.5 204.5 615 PI(D7) 32 7 187.44 249.72 1 60.0 109.5 210.0 1091 PI(M1) 37 2 192.59 293.38 1 27.0 85.0 186.0 1429 PII(D37) 31 6 124.94 153.75 1 32.0 76.0 168.0 595 PII(M2) 26 12 154.77 265.74 1 17.0 59.5 158.0 1139 PII(M7) 32 7 206.34 244.56 1 44.5 117.5 278.0 913 PII(M13) 35 3 180.03 196.21 1 62.0 102.0 196.0 807 PRE 32 7 74.16 138.34 1 1.0 1.0 65.5 458 PI(D7) 31 8 914.58 1516.08 1 58.0 165.0 1029.0 6309 PI(M1) 31 8 571.35 952.49 1 25.0 140.0 816.0 4036 PII(D37) 32 6 1945.13 2096.62 24 322.0 1290.5 2817.5 8089 PII(M2) 26 12 1072.81 1309.37 1 233.0 616.0 943.0 4559
CD4.CD40L(+) +IL2(+)+TNF- (+)+IFN- (-) PII(M7) 30 3 564.70 625.06 1 114.0 380.5 775.0 2530 PII(M13) 31 5 476.03 721.65 1 82.0 220.0 536.0 3110 PRE 31 7 72.84 129.03 1 1.0 23.0 77.0 573 PI(D7) 32 6 55.72 92.64 1 1.0 1.0 71.5 356 PI(M1) 33 5 43.82 79.31 1 1.0 1.0 53.0 382 PII(D37) 33 5 49.15 66.92 1 1.0 19.0 59.0 226 PII(M2) 30 8 42.17 47.89 1 1.0 24.0 86.0 181 PII(M7) 31 2 62.65 99.11 1 1.0 30.0 83.0 465 PII(M13) 32 4 82.09 165.70 1 1.0 29.0 92.5 882 HIV- HIV- PRE 32 7 139.91 132.93 1 29.5 93.0 257.5 508 PI(D7) 35 3 2236.26 3314.49 1 147.0 847.0 2817.0 15599 PI(M1) 21 17 790.81 1049.40 15 133.0 369.0 1139.0 4225 PII(D37) 21 17 1979.38 1780.63 133 458.0 1639.0 2917.0 5798 PII(M2) 32 5 930.88 802.03 25 320.0 754.0 1345.5 3359 PII(M7) 30 7 615.10 414.46 44 307.0 500.0 884.0 1660 PII(M13) 26 2 580.31 487.49 36 230.0 410.5 851.0 1906 HIV- PRE 28 11 211.25 303.43 1 19.5 105.0 240.5 1209 PI(D7) 33 6 277.42 363.69 1 21.0 125.0 408.0 1339 PI(M1) 20 18 144.85 245.75 1 18.5 57.5 99.0 959 PII(D37) 22 15 173.36 287.74 1 22.0 57.0 160.0 1049 PII(M2) 28 7 111.86 173.49 1 27.0 54.0 107.5 763 PII(M7) 31 4 176.45 249.99 1 44.0 106.0 174.0 1215 PII(M13) 28 3 163.89 181.99 1 26.0 128.5 204.5 755 PRE 34 5 36.59 48.50 1 1.0 9.0 65.0 199 PI(D7) 33 6 171.06 174.15 1 48.0 110.0 282.0 578 PI(M1) 31 7 636.90 615.50 1 296.0 450.0 698.0 2309 PII(D37) 27 10 2317.00 2145.06 1 806.0 1975.0 3245.0 9583 PII(M2) 23 14 3041.83 2763.57 1 1039.0 2162.0 4464.0 9518 PII(M7) 31 4 1675.48 1345.56 1 816.0 1370.0 2192.0 6901 PII(M13) 29 2 1879.72 1771.55 50 749.0 1536.0 2594.0 8293 PRE 36 3 54.44 166.49 1 1.0 1.5 40.0 995 PI(D7) 32 7 70.00 161.02 1 1.0 21.0 80.5 901 PI(M1) 37 2 58.81 139.52 1 1.0 26.0 58.0 832 PII(D37) 31 6 69.29 126.47 1 1.0 32.0 85.0 641 PII(M2) 26 12 34.65 44.93 1 1.0 11.0 59.0 163 PII(M7) 32 7 61.94 114.80 1 1.0 32.5 67.5 634 PII(M13) 35 3 78.34 194.90 1 1.0 30.0 70.0 1155 PRE 32 7 36.25 49.27 1 1.0 1.0 63.0 156 PI(D7) 31 8 100.81 135.84 1 1.0 42.0 226.0 560 PI(M1) 31 8 323.35 445.12 1 70.0 204.0 379.0 2356 PII(D37) 32 6 1023.31 1099.24 1 383.0 671.5 1040.0 4590 PII(M2) 26 12 1143.50 1246.69 127 499.0 788.5 1184.0 6042 PII(M7) 30 3 775.63 1408.02 1 161.0 305.5 678.0 7075 PII(M13) 31 5 632.39 1091.80 1 139.0 282.0 589.0 5070 PRE 31 7 21.48 44.32 1 1.0 1.0 19.0 193 PI(D7) 32 6 19.91 28.91 1 1.0 1.0 31.0 117 PI(M1) 33 5 29.48 42.11 1 1.0 16.0 46.0 202 PII(D37) 33 5 16.97 34.91 1 1.0 1.0 21.0 168 PII(M2) 30 8 25.43 39.05 1 1.0 1.0 33.0 138 PII(M7) 31 2 33.26 72.85 1 1.0 1.0 40.0 386 PII(M13) 32 4 25.09 35.61 1 1.0 1.0 37.0 112 HIV- HIV- PRE 32 7 20.28 24.44 1 1.0 7.0 37.0 93 PI(D7) 35 3 330.57 599.59 1 30.0 119.0 365.0 3254 PI(M1) 21 17 663.57 761.31 29 295.0 463.0 610.0 3534 PII(D37) 21 17 1618.33 1687.41 243 654.0 937.0 1458.0 6195 PII(M2) 32 5 990.91 1065.37 75 417.5 684.0 1207.0 5778
CD4.CD40L(+) +IL2(+)+TNF- (-)+IFN- (+) CD4.CD40L(+) +IL2(+)+TNF- (-)+IFN- (-) PII(M7) 30 7 642.73 406.96 58 326.0 600.5 934.0 1804 PII(M13) 26 2 702.54 966.64 43 262.0 411.0 780.0 5022 HIV- PRE 28 11 25.07 33.38 1 1.0 14.0 38.0 116 PI(D7) 33 6 22.73 29.72 1 1.0 5.0 34.0 105 PI(M1) 20 18 15.65 19.00 1 1.0 1.5 30.5 54 PII(D37) 22 15 30.77 41.17 1 1.0 2.5 44.0 145 PII(M2) 28 7 26.04 35.68 1 1.0 9.0 36.5 120 PII(M7) 31 4 23.29 30.36 1 1.0 15.0 31.0 124 PII(M13) 28 3 30.96 30.37 1 1.0 27.5 55.0 103 PRE 34 5 16.56 24.47 1 1.0 1.0 27.0 102 PI(D7) 33 6 206.94 288.64 1 31.0 74.0 255.0 1279 PI(M1) 31 7 76.77 65.82 1 20.0 63.0 130.0 261 PII(D37) 27 10 1051.63 832.70 1 364.0 816.0 1459.0 2949 PII(M2) 23 14 377.17 351.19 1 83.0 325.0 599.0 1189 PII(M7) 31 4 164.03 166.93 1 26.0 128.0 217.0 720 PII(M13) 29 2 201.86 234.63 1 39.0 160.0 212.0 1020 PRE 36 3 18.00 31.76 1 1.0 1.0 20.5 166 PI(D7) 32 7 14.06 18.52 1 1.0 1.0 23.0 74 PI(M1) 37 2 12.89 16.63 1 1.0 1.0 25.0 46 PII(D37) 31 6 15.13 24.24 1 1.0 1.0 25.0 111 PII(M2) 26 12 16.15 27.39 1 1.0 8.0 22.0 136 PII(M7) 32 7 25.63 37.35 1 1.0 17.0 32.0 169 PII(M13) 35 3 22.20 45.05 1 1.0 1.0 21.0 189 PRE 32 7 8.06 17.16 1 1.0 1.0 1.0 83 PI(D7) 31 8 145.35 177.01 1 1.0 65.0 278.0 691 PI(M1) 31 8 59.45 137.05 1 1.0 18.0 43.0 703 PII(D37) 32 6 837.38 925.15 24 214.0 507.0 1184.0 3829 PII(M2) 26 12 198.31 193.26 1 67.0 127.0 226.0 791 PII(M7) 30 3 48.17 75.43 1 1.0 8.5 53.0 286 PII(M13) 31 5 32.32 42.38 1 1.0 16.0 49.0 151 PRE 31 7 9.52 17.00 1 1.0 1.0 19.0 74 PI(D7) 32 6 22.09 35.84 1 1.0 1.0 27.0 136 PI(M1) 33 5 27.27 69.72 1 1.0 1.0 33.0 401 PII(D37) 33 5 9.82 16.53 1 1.0 1.0 15.0 74 PII(M2) 30 8 10.17 12.72 1 1.0 1.0 20.0 39 PII(M7) 31 2 10.35 23.38 1 1.0 1.0 3.0 116 PII(M13) 32 4 6.16 14.90 1 1.0 1.0 1.0 64 HIV- HIV- PRE 32 7 11.44 15.03 1 1.0 1.0 16.0 56 PI(D7) 35 3 325.86 559.08 1 25.0 148.0 413.0 3239 PI(M1) 21 17 79.00 84.80 1 44.0 60.0 95.0 360 PII(D37) 21 17 1099.57 1695.47 77 313.0 546.0 692.0 7629 PII(M2) 32 5 208.25 247.77 1 80.5 145.5 219.5 1089 PII(M7) 30 7 89.87 72.22 1 29.0 77.5 138.0 333 PII(M13) 26 2 86.15 115.52 1 1.0 58.0 100.0 482 HIV- PRE 28 11 10.07 14.25 1 1.0 1.0 18.5 49 PI(D7) 33 6 19.58 28.25 1 1.0 1.0 37.0 96 PI(M1) 20 18 12.45 15.88 1 1.0 1.0 25.0 54 PII(D37) 22 15 8.05 17.06 1 1.0 1.0 1.0 68 PII(M2) 28 7 14.43 18.52 1 1.0 5.5 19.5 71 PII(M7) 31 4 17.55 31.99 1 1.0 1.0 26.0 163 PII(M13) 28 3 16.04 28.92 1 1.0 1.0 26.5 122 PRE 34 5 10.00 14.43 1 1.0 1.0 16.0 51 PI(D7) 33 6 113.94 115.09 1 42.0 94.0 172.0 509 PI(M1) 31 7 475.23 518.33 1 174.0 351.0 507.0 2369 PII(D37) 27 10 2287.89 1716.82 1 787.0 2065.0 3498.0 5899 PII(M2) 23 14 1897.87 1799.16 1 855.0 1591.0 2307.0 8909
CD4.CD40L(+) +IL2(-)+TNF- (+)+IFN- (+) PII(M7) 31 4 630.77 561.24 38 259.0 476.0 970.0 2640 PII(M13) 29 2 758.41 1096.54 1 309.0 484.0 722.0 5910 PRE 36 3 24.83 39.28 1 1.0 1.0 33.5 132 PI(D7) 32 7 19.31 28.22 1 1.0 1.0 26.5 84 PI(M1) 37 2 14.00 21.02 1 1.0 1.0 23.0 88 PII(D37) 31 6 16.35 21.99 1 1.0 1.0 32.0 69 PII(M2) 26 12 10.85 17.61 1 1.0 1.0 13.0 58 PII(M7) 32 7 35.88 52.48 1 1.0 1.0 56.5 215 PII(M13) 35 3 22.09 29.21 1 1.0 1.0 40.0 97 PRE 32 7 20.22 36.73 1 1.0 1.0 32.0 129 PI(D7) 31 8 97.16 101.97 1 26.0 51.0 139.0 357 PI(M1) 31 8 137.10 151.78 1 13.0 113.0 180.0 647 PII(D37) 32 6 1056.31 1030.25 86 316.0 718.0 1545.0 4061 PII(M2) 26 12 543.35 441.24 1 191.0 425.5 779.0 1749 PII(M7) 30 3 157.83 223.79 1 6.0 78.0 225.0 1038 PII(M13) 31 5 147.26 219.62 1 1.0 103.0 198.0 968 PRE 31 7 20.42 33.00 1 1.0 1.0 30.0 144 PI(D7) 32 6 21.56 53.28 1 1.0 1.0 23.5 278 PI(M1) 33 5 7.97 20.32 1 1.0 1.0 1.0 106 PII(D37) 33 5 18.42 34.25 1 1.0 1.0 28.0 157 PII(M2) 30 8 18.77 43.78 1 1.0 1.0 1.0 181 PII(M7) 31 2 26.71 45.03 1 1.0 1.0 42.0 146 PII(M13) 32 4 17.88 36.17 1 1.0 1.0 13.0 141 HIV- HIV- PRE 32 7 12.81 20.41 1 1.0 1.0 20.5 76 PI(D7) 35 3 223.23 352.88 1 27.0 101.0 252.0 1568 PI(M1) 21 17 351.43 388.06 1 92.0 234.0 554.0 1758 PII(D37) 21 17 1946.48 2605.11 227 591.0 1145.0 1699.0 10978 PII(M2) 32 5 841.16 1203.86 1 285.5 510.5 993.0 6578 PII(M7) 30 7 276.83 190.06 21 145.0 247.0 381.0 716 PII(M13) 26 2 273.69 554.23 1 58.0 185.0 287.0 2929 HIV- PRE 28 11 21.86 40.70 1 1.0 1.0 27.0 152 PI(D7) 33 6 14.03 27.14 1 1.0 1.0 14.0 127 PI(M1) 20 18 19.10 42.80 1 1.0 1.0 16.0 182 PII(D37) 22 15 12.64 22.08 1 1.0 1.0 21.0 77 PII(M2) 28 7 20.68 28.71 1 1.0 1.0 42.5 115 PII(M7) 31 4 17.06 25.43 1 1.0 1.0 41.0 99 PII(M13) 28 3 10.14 22.28 1 1.0 1.0 1.0 88 PRE 34 5 227.53 1066.48 1 1.0 1.0 28.0 6206 PI(D7) 33 6 596.06 1450.33 1 23.0 66.0 486.0 7886 PI(M1) 31 7 432.00 1594.77 1 1.0 1.0 88.0 7781 PII(D37) 27 10 838.63 1372.86 55 128.0 391.0 1004.0 6699 PII(M2) 23 14 386.43 1297.79 1 14.0 57.0 186.0 6300 PII(M7) 31 4 57.03 72.79 1 1.0 32.0 83.0 286 PII(M13) 29 2 60.72 70.21 1 1.0 39.0 91.0 237 PRE 36 3 325.22 1286.66 1 1.0 15.0 63.5 7519 PI(D7) 32 7 154.22 476.19 1 1.0 1.0 41.5 2019 PI(M1) 37 2 441.76 1884.21 1 1.0 1.0 78.0 11299 PII(D37) 31 6 90.26 278.46 1 1.0 1.0 38.0 1419 PII(M2) 26 12 466.38 1916.38 1 1.0 1.0 45.0 9709 PII(M7) 32 7 24.94 37.08 1 1.0 8.5 28.0 130 PII(M13) 35 3 30.49 40.69 1 1.0 18.0 44.0 167 PRE 32 7 9.59 20.18 1 1.0 1.0 1.0 71 PI(D7) 31 8 124.90 201.22 1 1.0 28.0 141.0 725 PI(M1) 31 8 39.26 68.23 1 1.0 1.0 68.0 340 PII(D37) 32 6 350.94 421.22 1 58.5 214.0 511.5 1609 PII(M2) 26 12 85.96 144.52 1 1.0 28.5 92.0 654
CD4.CD40L(+) +IL2(-)+TNF- (+)+IFN- (-) PII(M7) 30 3 32.70 48.56 1 1.0 18.0 46.0 215 PII(M13) 31 5 22.68 40.61 1 1.0 1.0 30.0 197 PRE 31 7 180.61 939.08 1 1.0 1.0 12.0 5239 PI(D7) 32 6 114.50 571.69 1 1.0 1.0 26.5 3245 PI(M1) 33 5 87.85 453.00 1 1.0 1.0 13.0 2609 PII(D37) 33 5 13.97 32.36 1 1.0 1.0 2.0 147 PII(M2) 30 8 11.57 25.51 1 1.0 1.0 1.0 118 PII(M7) 31 2 27.29 54.28 1 1.0 1.0 36.0 280 PII(M13) 32 4 38.09 126.69 1 1.0 1.0 28.0 716 HIV- HIV- PRE 32 7 53.94 180.67 1 1.0 9.5 31.0 1025 PI(D7) 35 3 360.91 647.50 1 34.0 117.0 345.0 3279 PI(M1) 21 17 125.86 218.66 1 1.0 46.0 113.0 862 PII(D37) 21 17 564.24 785.43 49 173.0 318.0 578.0 3689 PII(M2) 32 5 115.19 130.61 1 23.0 76.5 180.0 499 PII(M7) 30 7 51.07 57.02 1 1.0 31.5 71.0 217 PII(M13) 26 2 54.12 62.15 1 15.0 35.0 85.0 241 HIV- PRE 28 11 36.46 58.05 1 1.0 19.0 49.0 283 PI(D7) 33 6 45.36 87.43 1 1.0 13.0 42.0 428 PI(M1) 20 18 19.75 29.58 1 1.0 1.0 33.5 113 PII(D37) 22 15 56.41 86.93 1 1.0 18.0 75.0 299 PII(M2) 28 7 36.89 48.62 1 1.0 14.5 51.0 163 PII(M7) 31 4 33.48 48.58 1 1.0 15.0 50.0 224 PII(M13) 28 3 21.36 30.05 1 1.0 1.0 35.5 108 PRE 34 5 27.97 55.89 1 1.0 1.0 25.0 253 PI(D7) 33 6 111.88 159.74 1 1.0 48.0 134.0 643 PI(M1) 31 7 99.23 120.82 1 1.0 54.0 125.0 412 PII(D37) 27 10 745.00 696.78 1 239.0 583.0 1040.0 2543 PII(M2) 23 14 346.17 368.95 1 50.0 274.0 542.0 1397 PII(M7) 31 4 87.65 88.41 1 3.0 48.0 164.0 263 PII(M13) 29 2 112.72 149.04 1 14.0 61.0 141.0 574 PRE 36 3 37.78 67.19 1 1.0 1.0 44.0 304 PI(D7) 32 7 38.72 61.46 1 1.0 1.0 57.0 229 PI(M1) 37 2 56.27 112.81 1 1.0 1.0 29.0 445 PII(D37) 31 6 39.16 60.27 1 1.0 17.0 55.0 210 PII(M2) 26 12 27.42 66.98 1 1.0 1.0 14.0 305 PII(M7) 32 7 52.09 62.69 1 1.0 27.0 72.5 242 PII(M13) 35 3 47.34 68.41 1 1.0 1.0 85.0 228 PRE 32 7 23.78 39.34 1 1.0 1.0 42.0 142 PI(D7) 31 8 53.39 55.53 1 1.0 34.0 80.0 214 PI(M1) 31 8 54.52 64.08 1 1.0 35.0 72.0 240 PII(D37) 32 6 328.41 380.07 1 69.0 211.5 456.0 1580 PII(M2) 26 12 64.15 70.33 1 2.0 30.0 103.0 242 PII(M7) 30 3 70.70 100.23 1 1.0 16.5 112.0 442 PII(M13) 31 5 47.74 83.17 1 1.0 30.0 49.0 435 PRE 31 7 25.29 52.16 1 1.0 1.0 38.0 244 PI(D7) 32 6 17.66 26.81 1 1.0 1.0 26.0 85 PI(M1) 33 5 24.58 33.66 1 1.0 1.0 34.0 107 PII(D37) 33 5 13.70 23.17 1 1.0 1.0 21.0 89 PII(M2) 30 8 15.63 27.50 1 1.0 1.0 30.0 94 PII(M7) 31 2 43.39 65.01 1 1.0 1.0 82.0 217 PII(M13) 32 4 42.94 71.90 1 1.0 2.0 42.5 259 HIV- HIV- PRE 32 7 15.13 31.88 1 1.0 1.0 20.0 165 PI(D7) 35 3 72.60 93.33 1 1.0 34.0 113.0 329 PI(M1) 21 17 124.57 156.82 1 26.0 81.0 136.0 551 PII(D37) 21 17 602.14 635.53 24 251.0 399.0 721.0 2416 PII(M2) 32 5 117.47 99.56 1 43.0 85.5 174.0 353
CD4.CD40L(+) +IL2(-)+TNF- (-)+IFN- (+) CD4.CD40L(+) +IL2(-)+TNF- (-)+IFN- (-) PII(M7) 30 7 65.37 53.59 1 12.0 72.0 99.0 187 PII(M13) 26 2 57.58 82.34 1 1.0 43.0 82.0 399 HIV- PRE 28 11 27.14 34.70 1 1.0 14.5 40.0 128 PI(D7) 33 6 25.79 49.71 1 1.0 1.0 28.0 229 PI(M1) 20 18 47.35 55.05 1 1.0 31.5 73.0 204 PII(D37) 22 15 26.05 42.28 1 1.0 1.0 37.0 136 PII(M2) 28 7 32.39 57.33 1 1.0 1.5 51.0 258 PII(M7) 31 4 34.90 52.61 1 1.0 4.0 57.0 239 PII(M13) 28 3 37.36 62.61 1 1.0 1.0 29.5 218 PRE 34 5 24.09 67.65 1 1.0 1.0 20.0 387 PI(D7) 33 6 138.21 132.12 1 24.0 117.0 209.0 480 PI(M1) 31 7 55.45 116.64 1 1.0 21.0 58.0 582 PII(D37) 27 10 817.30 843.68 1 287.0 725.0 973.0 4105 PII(M2) 23 14 111.39 158.90 1 15.0 74.0 119.0 683 PII(M7) 31 4 34.00 32.07 1 1.0 26.0 54.0 130 PII(M13) 29 2 27.28 33.92 1 1.0 15.0 46.0 107 PRE 36 3 36.28 110.42 1 1.0 4.0 33.0 666 PI(D7) 32 7 27.16 41.73 1 1.0 1.0 39.5 171 PI(M1) 37 2 36.89 100.20 1 1.0 13.0 33.0 609 PII(D37) 31 6 10.19 18.10 1 1.0 1.0 16.0 74 PII(M2) 26 12 42.92 148.02 1 1.0 1.0 23.0 762 PII(M7) 32 7 10.94 17.48 1 1.0 1.0 19.0 64 PII(M13) 35 3 32.40 131.50 1 1.0 1.0 18.0 781 PRE 32 7 16.94 37.16 1 1.0 1.0 12.5 166 PI(D7) 31 8 108.58 154.57 1 1.0 51.0 171.0 736 PI(M1) 31 8 30.77 45.97 1 1.0 1.0 49.0 178 PII(D37) 32 6 638.94 749.32 1 167.5 388.0 694.0 3109 PII(M2) 26 12 40.73 53.95 1 1.0 28.5 44.0 213 PII(M7) 30 3 16.73 27.22 1 1.0 1.0 22.0 115 PII(M13) 31 5 10.16 15.75 1 1.0 1.0 22.0 65 PRE 31 7 14.19 18.05 1 1.0 1.0 32.0 56 PI(D7) 32 6 27.38 72.00 1 1.0 1.0 32.0 407 PI(M1) 33 5 31.85 90.00 1 1.0 1.0 3.0 393 PII(D37) 33 5 9.24 15.99 1 1.0 1.0 16.0 67 PII(M2) 30 8 17.13 24.93 1 1.0 1.0 27.0 104 PII(M7) 31 2 10.71 21.85 1 1.0 1.0 17.0 105 PII(M13) 32 4 10.94 23.25 1 1.0 1.0 11.5 119 HIV- HIV- PRE 32 7 14.78 20.76 1 1.0 1.5 22.5 92 PI(D7) 35 3 188.54 265.63 1 30.0 84.0 255.0 1285 PI(M1) 21 17 33.48 45.73 1 1.0 22.0 43.0 193 PII(D37) 21 17 826.52 684.12 59 399.0 740.0 1129.0 2966 PII(M2) 32 5 65.91 55.41 1 19.5 55.0 100.0 212 PII(M7) 30 7 19.53 24.43 1 1.0 7.5 29.0 89 PII(M13) 26 2 21.46 30.17 1 1.0 13.5 28.0 113 HIV- PRE 28 11 27.93 43.06 1 1.0 7.5 42.5 198 PI(D7) 33 6 13.27 22.75 1 1.0 1.0 16.0 95 PI(M1) 20 18 17.50 20.54 1 1.0 13.5 29.5 79 PII(D37) 22 15 15.05 16.60 1 1.0 8.0 24.0 47 PII(M2) 28 7 21.07 23.00 1 1.0 13.5 45.5 68 PII(M7) 31 4 17.71 32.78 1 1.0 1.0 18.0 149 PII(M13) 28 3 10.79 19.90 1 1.0 1.0 14.0 89 PRE 34 5 258.53 1010.32 1 1.0 1.0 1.0 5700 PI(D7) 33 6 302.82 989.59 1 1.0 1.0 150.0 5600 PI(M1) 31 7 148.81 370.53 1 1.0 1.0 100.0 1830 PII(D37) 27 10 1998.70 1836.63 1 510.0 1510.0 3520.0 5990 PII(M2) 23 14 656.17 867.26 1 1.0 1.0 1110.0 3000