Human Immunodeficiency Virus HIV 2 Preventive HIV Vaccine

Human Immunodeficiency Virus (HIV) 2

Preventive HIV Vaccine (cont. ) § AIDSVAX B/E • bivalent HIV gp 120 envelope glycoprotein vaccine • containing a subtype E envelope and a subtype B envelope 8

Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med 2009; 361: 1 -12. 9

Background The development of a safe and effective vaccine against the human immunodeficiency virus type 1 (HIV-1) is critical to pandemic control. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med 2009; 361: 1 -12. 10

Method • A community-based, randomized, multicenter, double-blind, placebocontrolled efficacy trial • Evaluated the vaccine and placebo (priming : ALVAC-HIV [v. CP 1521] plus two booster : AIDSVAX B/E). • 16, 402 patients (18 -30 y, heterosexual) • Rayong and Chon Buri • Follow up 3 years Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med 2009; 361: 1 -12. 11

Results Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med 2009; 361: 1 -12. 12

Intention-to-treat (ITT : 16, 402 subjects) vaccine efficacy was 26. 4% (95% CI, − 4. 0 to 47. 9; P = 0. 08) 13

Per-protocol (12, 452 subjects) vaccine efficacy was 26. 2% (95% CI, − 13. 3 to 51. 9; P = 0. 16) 14

Modified intention-to-treat (m. ITT 16, 395 subjects) vaccine efficacy was 31. 2% (95% CI, 1. 1 to 51. 2; P = 0. 04) 15

Results (cont. ) Vaccination did not affect the degree of viremia or the CD 4+ T-cell count. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med 2009; 361: 1 -12. 16

Conclusions This ALVAC-HIV and AIDSVAX B/E vaccine regimen may reduce the risk of HIV infection in a community-based population with largely heterosexual risk. Vaccination did not affect the viral load or CD 4+ count in subjects with HIV infection. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med 2009; 361: 1 -12. 17

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Population 21

Inclusion /Exclusion criteria • Inclusion criteria – Male and female – 18 -30 years – Not infected with HIV • Exclusion criteria – Pregnant and breast-feeding women 22

Baseline characteristic 23

Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med 2009; 361: 1 -12. 24

Outcomes • Primary outcome – Co-primary outcome : prevention of HIV-1 and viral load after infection 27

http: //uhavax. hartford. edu/bugl/images/HIV-graph. jpg 28

Time • Screening-vaccination>>>ไมเหมาะสม • Within vaccination>>>เหมาะสม • Follow – up >>>เหมาะสม 29

Statistical Methods • Analysis – Wilcoxon rank sum test : comparing between group – Cox proportional hazard model – ITT , Per-protocol and m. ITT 30

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