@article{Gray2021a,
abstract = {BACKGROUND A safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox–protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1–2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa. METHODS In this phase 2b–3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120–MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months. RESULTS In January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70{\%} of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month followup, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95{\%} confidence interval, 0.81 to 1.30; P=0.84). CONCLUSIONS The ALVAC–gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity.},
author = {Gray, G.E. and Bekker, L.-G. and Laher, F. and Malahleha, M. and Allen, M. and Moodie, Z. and Grunenberg, N. and Huang, Y. and Grove, D. and Prigmore, B. and Janes, H. and Corey, L.},
doi = {10.1056/NEJMoa2031499},
journal = {New England Journal of Medicine},
number = {12},
pages = {1089--1100},
title = {{Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120–MF59 in adults}},
volume = {384},
year = {2021}
}

{"_id":"JZitwzK8ak962zLCj","bibbaseid":"gray-bekker-laher-malahleha-allen-moodie-grunenberg-huang-etal-vaccineefficacyofalvachivandbivalentsubtypecgp120mf59inadults-2021","author_short":["Gray, G.","Bekker, L.","Laher, F.","Malahleha, M.","Allen, M.","Moodie, Z.","Grunenberg, N.","Huang, Y.","Grove, D.","Prigmore, B.","Janes, H.","Corey, L."],"bibdata":{"bibtype":"article","type":"article","abstract":"BACKGROUND A safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox–protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1–2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa. METHODS In this phase 2b–3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120–MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months. RESULTS In January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70% of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month followup, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.81 to 1.30; P=0.84). CONCLUSIONS The ALVAC–gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity.","author":[{"propositions":[],"lastnames":["Gray"],"firstnames":["G.E."],"suffixes":[]},{"propositions":[],"lastnames":["Bekker"],"firstnames":["L.-G."],"suffixes":[]},{"propositions":[],"lastnames":["Laher"],"firstnames":["F."],"suffixes":[]},{"propositions":[],"lastnames":["Malahleha"],"firstnames":["M."],"suffixes":[]},{"propositions":[],"lastnames":["Allen"],"firstnames":["M."],"suffixes":[]},{"propositions":[],"lastnames":["Moodie"],"firstnames":["Z."],"suffixes":[]},{"propositions":[],"lastnames":["Grunenberg"],"firstnames":["N."],"suffixes":[]},{"propositions":[],"lastnames":["Huang"],"firstnames":["Y."],"suffixes":[]},{"propositions":[],"lastnames":["Grove"],"firstnames":["D."],"suffixes":[]},{"propositions":[],"lastnames":["Prigmore"],"firstnames":["B."],"suffixes":[]},{"propositions":[],"lastnames":["Janes"],"firstnames":["H."],"suffixes":[]},{"propositions":[],"lastnames":["Corey"],"firstnames":["L."],"suffixes":[]}],"doi":"10.1056/NEJMoa2031499","journal":"New England Journal of Medicine","number":"12","pages":"1089–1100","title":"Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120–MF59 in adults","volume":"384","year":"2021","bibtex":"@article{Gray2021a,\nabstract = {BACKGROUND A safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox–protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1–2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa. METHODS In this phase 2b–3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120–MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months. RESULTS In January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70{\\%} of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month followup, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95{\\%} confidence interval, 0.81 to 1.30; P=0.84). CONCLUSIONS The ALVAC–gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity.},\nauthor = {Gray, G.E. and Bekker, L.-G. and Laher, F. and Malahleha, M. and Allen, M. and Moodie, Z. and Grunenberg, N. and Huang, Y. and Grove, D. and Prigmore, B. and Janes, H. and Corey, L.},\ndoi = {10.1056/NEJMoa2031499},\njournal = {New England Journal of Medicine},\nnumber = {12},\npages = {1089--1100},\ntitle = {{Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120–MF59 in adults}},\nvolume = {384},\nyear = {2021}\n}\n","author_short":["Gray, G.","Bekker, L.","Laher, F.","Malahleha, M.","Allen, M.","Moodie, Z.","Grunenberg, N.","Huang, Y.","Grove, D.","Prigmore, B.","Janes, H.","Corey, L."],"key":"Gray2021a","id":"Gray2021a","bibbaseid":"gray-bekker-laher-malahleha-allen-moodie-grunenberg-huang-etal-vaccineefficacyofalvachivandbivalentsubtypecgp120mf59inadults-2021","role":"author","urls":{},"metadata":{"authorlinks":{}}},"bibtype":"article","biburl":"https://drive.google.com/uc?export=download&id=1-9gwO2GBrWfUK-fFo05cgfzXdRK_w9xL","dataSources":["Krmt6gt9ktB2s6ARh","9bX4N36CTXtCXNFMd","wrEvssexmuYudwQw9","6GMFi5DCojy3jHY44"],"keywords":[],"search_terms":["vaccine","efficacy","alvac","hiv","bivalent","subtype","gp120","mf59","adults","gray","bekker","laher","malahleha","allen","moodie","grunenberg","huang","grove","prigmore","janes","corey"],"title":"Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120–MF59 in adults","year":2021}