Supachai Rerks-NgarmPunnee PitisuttithumSorachai NitayaphanJaranit KaewkungwalJoseph ChiuRobert ParisNakorn PremsriChawetsan NamwatMark De SouzaElizabeth AdamsMichael BenensonSanjay GurunathanJim TartagliaJohn G. McNeilDonald P. FrancisDonald StableinDeborah L. BirxSupamit ChunsuttiwatChirasak KhamboonruangPrasert ThongcharoenMerlin L. RobbNelson L. MichaelPrayura KunasolJerome H. KimThailand Ministry of Public HealthMahidol UniversityArmed Forces Research Institute of Medical Sciences, ThailandNational Institute of Allergy and Infectious DiseasesSanofi PasteurGlobal Solutions for Infectious DiseasesThe EMMES CorporationCenters for Disease Control and PreventionWalter Reed Army Institute of ResearchUS Army Medical Materiel Development Activity2018-09-132018-09-132009-12-03New England Journal of Medicine. Vol.361, No.23 (2009), 2209-222015334406002847932-s2.0-73349094086https://repository.li.mahidol.ac.th/handle/20.500.14594/27795BACKGROUND: The development of a safe and effective vaccine against the human immunodeficiency virus type 1 (HIV-1) is critical to pandemic control. METHODS: In a community-based, randomized, multicenter, double-blind, placebo-controlled efficacy trial, we evaluated four priming injections of a recombinant canarypox vector vaccine (ALVAC-HIV [vCP1521]) plus two booster injections of a recombinant glycoprotein 120 subunit vaccine (AIDSVAX B/E). The vaccine and placebo injections were administered to 16,402 healthy men and women between the ages of 18 and 30 years in Rayong and Chon Buri provinces in Thailand. The volunteers, primarily at heterosexual risk for HIV infection, were monitored for the coprimary end points: HIV-1 infection and early HIV-1 viremia, at the end of the 6-month vaccination series and every 6 months thereafter for 3 years. RESULTS: In the intention-to-treat analysis involving 16,402 subjects, there was a trend toward the prevention of HIV-1 infection among the vaccine recipients, with a vaccine efficacy of 26.4% (95% confidence interval [CI], -4.0 to 47.9; P = 0.08). In the perprotocol analysis involving 12,542 subjects, the vaccine efficacy was 26.2% (95% CI, -13.3 to 51.9; P = 0.16). In the modified intention-to-treat analysis involving 16,395 subjects (with the exclusion of 7 subjects who were found to have had HIV-1 infection at baseline), the vaccine efficacy was 31.2% (95% CI, 1.1 to 52.1; P = 0.04). Vaccination did not affect the degree of viremia or the CD4+ T-cell count in subjects in whom HIV-1 infection was subsequently diagnosed. 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 CD4+ count in subjects with HIV infection. Although the results show only a modest benefit, they offer insight for future research. (ClinicalTrials.gov number, NCT00223080.). Copyright © 2009 Massachusetts Medical Society.video/youtubeMahidol UniversityMedicineArticleSCOPUS10.1056/NEJMoa0908492