Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120

Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120–MF59 in adults. Gray, G. E, Bekker, L., Laher, F., Malahleha, M., Allen, M., Moodie, Z., Grunenberg, N., Huang, Y., Grove, D., Prigmore, B., Kee, J. J., Benkeser, D., Hural, J., Innes, C., Lazarus, E., Meintjes, G., Naicker, N., Kalonji, D., Nchabeleng, M., Sebe, M., Singh, N., Kotze, P., Kassim, S., Dubula, T., Naicker, V., Brumskine, W., Ncayiya, C. N, Ward, A. M, Garrett, N., Kistnasami, G., Gaffoor, Z., Selepe, P., Makhoba, P. B, Mathebula, M. P, Mda, P., Adonis, T., Mapetla, K. S, Modibedi, B., Philip, T., Kobane, G., Bentley, C., Ramirez, S., Takuva, S., Jones, M., Sikhosana, M., Atujuna, M., Andrasik, M., Hejazi, N. S, Puren, A., Wiesner, L., Phogat, S., Diaz Granados, C., Koutsoukos, M., Van Der Meeren, O., Barnett, S. W, Kanesa-Thasan, N., Kublin, J. G, McElrath, M J., Gilbert, P. B, Janes, H., & Corey, L. New England Journal of Medicine, 384(12):1089–1100, Massachusetts Medical Society, mar, 2021.

Paper doi abstract bibtex

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 follow-up, 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. (HVTN 702 ClinicalTrials.gov number, NCT02968849.).

@article{Gray2021,
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 follow-up, 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. (HVTN 702 ClinicalTrials.gov number, NCT02968849.).},
author = {Gray, Glenda E and Bekker, Linda-Gail and Laher, Fatima and Malahleha, Mookho and Allen, Mary and Moodie, Zoe and Grunenberg, Nicole and Huang, Yunda and Grove, Doug and Prigmore, Brittany and Kee, Jia J. and Benkeser, David and Hural, John and Innes, Craig and Lazarus, Erica and Meintjes, Graeme and Naicker, Nivashnee and Kalonji, Dishiki and Nchabeleng, Maphoshane and Sebe, Modulakgotla and Singh, Nishanta and Kotze, Philip and Kassim, Sheetal and Dubula, Thozama and Naicker, Vimla and Brumskine, William and Ncayiya, Cleon N and Ward, Amy M and Garrett, Nigel and Kistnasami, Girisha and Gaffoor, Zakir and Selepe, Pearl and Makhoba, Philisiwe B and Mathebula, Matsontso P and Mda, Pamela and Adonis, Tania and Mapetla, Katlego S and Modibedi, Bontle and Philip, Tricia and Kobane, Gladys and Bentley, Carter and Ramirez, Shelly and Takuva, Simbarashe and Jones, Megan and Sikhosana, Mpho and Atujuna, Millicent and Andrasik, Michele and Hejazi, Nima S and Puren, Adrian and Wiesner, Lubbe and Phogat, Sanjay and {Diaz Granados}, Carlos and Koutsoukos, Marguerite and {Van Der Meeren}, Olivier and Barnett, Susan W and Kanesa-Thasan, Niranjan and Kublin, James G and McElrath, M Juliana and Gilbert, Peter B and Janes, Holly and Corey, Lawrence},
doi = {10.1056/NEJMoa2031499},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Gray et al. - 2021 - Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120–MF59 in adults.pdf:pdf},
issn = {0028-4793},
journal = {New England Journal of Medicine},
keywords = {OA,fund{\_}not{\_}ack,original},
mendeley-tags = {OA,fund{\_}not{\_}ack,original},
month = {mar},
number = {12},
pages = {1089--1100},
pmid = {33761206},
publisher = {Massachusetts Medical Society},
title = {{Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120–MF59 in adults}},
url = {http://www.nejm.org/doi/10.1056/NEJMoa2031499},
volume = {384},
year = {2021}
}

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