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2. Copyright © 2009 Massachusetts Medical Society. All rights reserved. Published by Massachusetts Medical Society. 2 Figure 1 Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. Rerks-Ngarm, Supachai; Pitisuttithum, Punnee; Nitayaphan, Sorachai; Kaewkungwal, Jaranit; Chiu, Joseph; Paris, Robert; Premsri, Nakorn; Namwat, Chawetsan; de Souza, Mark; Adams, Elizabeth; Benenson, Michael; Gurunathan, Sanjay; Tartaglia, Jim; McNeil, John; Francis, Donald; Stablein, Donald; Birx, Deborah; Chunsuttiwat, Supamit; Khamboonruang, Chirasak; Thongcharoen, Prasert; Robb, Merlin; Michael, Nelson; Kunasol, Prayura; Kim, Jerome New England Journal of Medicine. 361(23):2209-2220, December 3, 2009. Figure 1. Enrollment and Outcomes.During the course of the study, there were 15 HIV-1 infections in the vaccine group and 24 in the placebo group that were excluded from the final analysis. This left 12,542 volunteers (6176 in the vaccine group and 6366 in the placebo group) who received all four doses of vaccine within the prespecified time period, who were not excluded for the other reasons, and who did not have HIV-1 infection at visit 7 (per-protocol population).

3. Copyright © 2009 Massachusetts Medical Society. All rights reserved. Published by Massachusetts Medical Society. 3 Table 1 Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. Rerks-Ngarm, Supachai; Pitisuttithum, Punnee; Nitayaphan, Sorachai; Kaewkungwal, Jaranit; Chiu, Joseph; Paris, Robert; Premsri, Nakorn; Namwat, Chawetsan; de Souza, Mark; Adams, Elizabeth; Benenson, Michael; Gurunathan, Sanjay; Tartaglia, Jim; McNeil, John; Francis, Donald; Stablein, Donald; Birx, Deborah; Chunsuttiwat, Supamit; Khamboonruang, Chirasak; Thongcharoen, Prasert; Robb, Merlin; Michael, Nelson; Kunasol, Prayura; Kim, Jerome New England Journal of Medicine. 361(23):2209-2220, December 3, 2009. Table 1. Baseline Characteristics of the Subjects (Modified Intention-to-Treat Population).

4. Copyright © 2009 Massachusetts Medical Society. All rights reserved. Published by Massachusetts Medical Society. 4 Figure 2 Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. Rerks-Ngarm, Supachai; Pitisuttithum, Punnee; Nitayaphan, Sorachai; Kaewkungwal, Jaranit; Chiu, Joseph; Paris, Robert; Premsri, Nakorn; Namwat, Chawetsan; de Souza, Mark; Adams, Elizabeth; Benenson, Michael; Gurunathan, Sanjay; Tartaglia, Jim; McNeil, John; Francis, Donald; Stablein, Donald; Birx, Deborah; Chunsuttiwat, Supamit; Khamboonruang, Chirasak; Thongcharoen, Prasert; Robb, Merlin; Michael, Nelson; Kunasol, Prayura; Kim, Jerome New England Journal of Medicine. 361(23):2209-2220, December 3, 2009. Figure 2. Kaplan-Meier Cumulative Rates of Infection, According to Type of Analysis.The vaccination regimen was completed approximately 6 months after the first dose was administered. In the intention-to-treat analysis involving 16,402 subjects, the vaccine efficacy was 26.4% (95% confidence interval [CI], -4.0 to 47.9; P=0.08) (Panel A). In the per-protocol analysis involving 12,542 subjects, the vaccine efficacy was 26.2% (95% CI, -13.3 to 51.9; P=0.16) (Panel B). In the modified intention-to-treat analysis involving 16,395 subjects (excluding 7 subjects who were found to have had HIV infection at baseline), the vaccine efficacy was 31.2% (95% CI, 1.1 to 51.2; P=0.04) (Panel C).

5. Copyright © 2009 Massachusetts Medical Society. All rights reserved. Published by Massachusetts Medical Society. 5 Table 2 Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. Rerks-Ngarm, Supachai; Pitisuttithum, Punnee; Nitayaphan, Sorachai; Kaewkungwal, Jaranit; Chiu, Joseph; Paris, Robert; Premsri, Nakorn; Namwat, Chawetsan; de Souza, Mark; Adams, Elizabeth; Benenson, Michael; Gurunathan, Sanjay; Tartaglia, Jim; McNeil, John; Francis, Donald; Stablein, Donald; Birx, Deborah; Chunsuttiwat, Supamit; Khamboonruang, Chirasak; Thongcharoen, Prasert; Robb, Merlin; Michael, Nelson; Kunasol, Prayura; Kim, Jerome New England Journal of Medicine. 361(23):2209-2220, December 3, 2009. Table 2. Rate of HIV Infection and Vaccine Efficacy, According to Selected Baseline Variables (Modified Intention-to-Treat Population).

6. Copyright © 2009 Massachusetts Medical Society. All rights reserved. Published by Massachusetts Medical Society. 6 Figure 3 Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. Rerks-Ngarm, Supachai; Pitisuttithum, Punnee; Nitayaphan, Sorachai; Kaewkungwal, Jaranit; Chiu, Joseph; Paris, Robert; Premsri, Nakorn; Namwat, Chawetsan; de Souza, Mark; Adams, Elizabeth; Benenson, Michael; Gurunathan, Sanjay; Tartaglia, Jim; McNeil, John; Francis, Donald; Stablein, Donald; Birx, Deborah; Chunsuttiwat, Supamit; Khamboonruang, Chirasak; Thongcharoen, Prasert; Robb, Merlin; Michael, Nelson; Kunasol, Prayura; Kim, Jerome New England Journal of Medicine. 361(23):2209-2220, December 3, 2009. Figure 3. Viral Loads in Subjects with Early HIV-1 Infection.The receipt of vaccine did not have a significant effect on the viral load in subjects who were found to have early HIV-1 infection. On the left are the mean log10 viral loads at three visits during a 6-week period for subjects who were included in the intention-to-treat analysis. The data points at the right show the distribution of viral loads in the vaccine group (mean, 4.36 log10 copies per milliliter) and the placebo group (mean, 4.21 log10 copies per milliliter) (P=0.09). There was no significant between-group difference in viral load in either the per-protocol analysis (P=0.47) or the modified intention-to-treat analysis (P=0.24).

7. Copyright © 2009 Massachusetts Medical Society. All rights reserved. Published by Massachusetts Medical Society. 7 Table 3 Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. Rerks-Ngarm, Supachai; Pitisuttithum, Punnee; Nitayaphan, Sorachai; Kaewkungwal, Jaranit; Chiu, Joseph; Paris, Robert; Premsri, Nakorn; Namwat, Chawetsan; de Souza, Mark; Adams, Elizabeth; Benenson, Michael; Gurunathan, Sanjay; Tartaglia, Jim; McNeil, John; Francis, Donald; Stablein, Donald; Birx, Deborah; Chunsuttiwat, Supamit; Khamboonruang, Chirasak; Thongcharoen, Prasert; Robb, Merlin; Michael, Nelson; Kunasol, Prayura; Kim, Jerome New England Journal of Medicine. 361(23):2209-2220, December 3, 2009. Table 3. Immunogenicity Analyses at Baseline and 12 Months.