The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

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1 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: GSK Study Number: Title: Safety and immunogenicity of GSK Biologicals candidate tuberculosis vaccine (692342) when administered to HIV*- positive adults living in a TB* endemic region (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 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 : 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 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):

2 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.

3 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 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 Randomised, N (Total Vaccinated cohort) 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) 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 Minimum Maximum

4 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 (%) (2.5) - - Asian - South East Asian heritage, n (%) (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 Grade 3* Swelling Any > 50 mm* Dose 2 Pain Any Grade 3* Swelling Any > 50 mm* Across Doses Pain Any Grade 3* Swelling Any > 50 mm* 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 Grade 3* Swelling Any > 50 mm* Dose 2 Pain Any Grade 3* Swelling Any > 50 mm* Across Doses Pain Any Grade 3* Swelling Any > 50 mm* 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

5 Dose 1 Fatigue Any Related Grade 3* Gastrointestinal symptoms Any Related Grade 3* Headache Any Related Grade 3* Malaise Any Related Grade 3* Myalgia Any Related Grade 3* Temperature (Axillary route) Any Related > 39.5 C* Dose 2 Fatigue Any Related Grade 3* Gastrointestinal symptoms Any Related Grade 3* Headache Any Related Grade 3* Malaise Any Related Grade 3* Myalgia Any Related Grade 3* Temperature (Axillary route) Any Related > 39.5 C* Across Doses Fatigue Any Related Grade 3* Gastrointestinal symptoms Any Related Grade 3* Headache Any Related Grade 3* Malaise Any Related Grade 3* Myalgia Any Related Grade 3* Temperature (Axillary route) Any Related

6 > 39.5 C* 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 Related Grade 3* Gastrointestinal symptoms Any Related Grade 3* Headache Any Related Grade 3* Malaise Any Related Grade 3* Myalgia Any Related Grade 3* Temperature (Axillary route) Any Related > 39.5 C* Dose 2 Fatigue Any Related Grade 3* Gastrointestinal symptoms Any Related Grade 3* Headache Any Related Grade 3* Malaise Any Related Grade 3* Myalgia Any Related Grade 3* Temperature (Axillary route) Any Related > 39.5 C* Across Doses Fatigue Any Related Grade 3* Gastrointestinal symptoms Any Related Grade 3* Headache Any Related Grade 3* Malaise Any Related Grade 3*

7 Myalgia Any Related Grade 3* Temperature (Axillary route) Any Related > 39.5 C* 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 Grade Grade Grade 3* Grade 4* PI(D7) 1. Normal Grade Grade Grade 3* Grade 4* PI(M1) 1. Normal Grade Grade Grade 3* Grade 4* PII(D37) 1. Normal Grade Grade Grade 3* Grade 4* Missing PII(M2) 1. Normal Grade Grade Grade 3* Grade 4* White Blood Cells PRE 1. Normal Grade Grade PI(D7) 1. Normal Grade Grade

8 PI(M1) 1. Normal Grade Grade Grade 4* PII(D37) 1. Normal Grade Grade Missing PII(M2) 1. Normal Grade Grade Platelets PRE 1. Normal Grade Grade Grade 3* Grade 4* PI(D7) 1. Normal Grade Grade Grade 3* Grade 4* PI(M1) 1. Normal Grade Grade Grade 4* PII(D37) 1. Normal Grade Grade Grade 3* Grade 4* Missing PII(M2) 1. Normal Grade Grade Grade 4* ALAT PRE 1. Normal Grade Grade PI(D7) 1. Normal Grade Grade PI(M1) 1. Normal Grade Grade

9 PII(D37) 1. Normal Grade Grade PII(M2) 1. Normal Grade Grade Grade 3* ASAT PRE 1. Normal Grade Grade PI(D7) 1. Normal Grade Grade PI(M1) 1. Normal Grade Grade PII(D37) 1. Normal Grade Grade PII(M2) 1. Normal Grade Grade Grade 3* Creatinine PRE 1. Normal Grade Grade Grade 3* PI(D7) 1. Normal Grade Grade Grade 3* PI(M1) 1. Normal Grade Grade Grade 3* PII(D37) 1. Normal Grade Grade Grade 3*

10 PII(M2) 1. Normal Grade Grade Grade 3* Red Blood Cells PRE 1. Normal Grade Grade PI(D7) 1. Normal Grade Grade PI(M1) 1. Normal Grade Grade PII(D37) 1. Normal Grade Grade Missing PII(M2) 1. Normal Grade Grade 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 PI(M1) PII(M2) PII(M7) PII(M13) PRE PI(M1) PII(M2)

11 PII(M7) PII(M13) PRE PI(M1) PII(M2) PII(M7) PII(M13) PRE PI(M1) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(M1) PII(M2) PII(M7) PII(M13) HIV- PRE PI(M1) PII(M2) PII(M7) PII(M13) 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 doubles PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13)

12 PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) 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 PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2)

13 CD4.CD40L(+) +IL2(+)+TNF- (+)+IFN- (-) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2)

14 CD4.CD40L(+) +IL2(+)+TNF- (-)+IFN- (+) CD4.CD40L(+) +IL2(+)+TNF- (-)+IFN- (-) PII(M7) PII(M13) HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2)

15 CD4.CD40L(+) +IL2(-)+TNF- (+)+IFN- (+) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2)

16 CD4.CD40L(+) +IL2(-)+TNF- (+)+IFN- (-) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2)

17 CD4.CD40L(+) +IL2(-)+TNF- (-)+IFN- (+) CD4.CD40L(+) +IL2(-)+TNF- (-)+IFN- (-) PII(M7) PII(M13) HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) HIV- PRE PI(D7) PI(M1) PII(D37) PII(M2) PII(M7) PII(M13) PRE PI(D7) PI(M1) PII(D37) PII(M2)