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Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120–MF59 in Adults
Open accessAbstract
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.).
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Delany-Moretlwe, S., Hughes, J. P., Bock, P., Ouma, S. G., Hunidzarira, P., Kalonji, D., Kayange, N., Makhema, J., Mandima, P., Mathew, C., et al. (2022) · The Lancet · doi:10.1016/s0140-6736(22)00538-4 · Cited by 586
Self-citationShangguan, S., Ehrenberg, P. K., Geretz, A., Yum, L., Kundu, G., May, K., Fourati, S., Nganou-Makamdop, K., Williams, L. D., Sawant, S., et al. (2021) · eLife · doi:10.7554/elife.69577 · Cited by 26
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Metadata
- Authors
- Gray, G. E., Bekker, L.-G., 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.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-03-25
- Volume
- 384
- Issue
- 12
- Pages
- 1089-1100
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3137307641
- Cited by
- 230
- References
- 0
- FWCI
- 22.16
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Gray, G. E., Bekker, L.-G., 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., . . . Corey, L. (2021). Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120–MF59 in Adults. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2031499
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