Analysis of the HVTN 702 Phase 2b-3 HIV-1 vaccine trial in South Africa assessing RV144 antibody and T-cell correlates of HIV-1 acquisition risk. Moodie, Z., Dintwe, O., Sawant, S., Grove, D., Huang, Y., Janes, H., Heptinstall, J., Laher Omar, F., Cohen, K., De Rosa, S. C, Zhang, L., Yates, N. L, Sarzotti-Kelsoe, M., Seaton, K. E, Laher, F., Bekker, L. G., Malahleha, M., Innes, C., Kassim, S., Naicker, N., Govender, V., Sebe, M., Singh, N., Kotze, P., Lazarus, E., Nchabeleng, M., Ward, A. M, Brumskine, W., Dubula, T., Randhawa, A. K, Grunenberg, N., Hural, J., Kee, J. J., Benkeser, D., Jin, Y., Carpp, L. N, Allen, M., D'Souza, P., Tartaglia, J., DiazGranados, C. A, Koutsoukos, M., Gilbert, P. B, Kublin, J. G, Corey, L., Andersen-Nissen, E., Gray, G. E, Tomaras, G. D, & McElrath, M J. The Journal of Infectious Diseases, 226(2):246–257, jun, 2022.
Analysis of the HVTN 702 Phase 2b-3 HIV-1 vaccine trial in South Africa assessing RV144 antibody and T-cell correlates of HIV-1 acquisition risk [link]Paper  doi  abstract   bibtex   
Background The ALVAC/gp120 + MF59 vaccines in the HVTN 702 efficacy trial did not prevent HIV-1 acquisition. Vaccine-matched immunological endpoints that were correlates of HIV-1 acquisition risk in RV144 were measured in HVTN 702 and evaluated as correlates of HIV-1 acquisition. Methods Among 1893 HVTN 702 female vaccinees, 60 HIV-1-seropositive cases and 60 matched seronegative non-cases were sampled. HIV-specific CD4+ T-cell and binding antibody responses were measured 2 weeks post-fourth and fifth immunizations. Cox proportional hazards models assessed pre-specified responses as predictors of HIV-1 acquisition. Results The HVTN 702 Env-specific CD4+ T-cell response rate was significantly higher than in RV144 (63% vs. 40%, P = 0.03) with significantly lower IgG binding antibody response rate and magnitude to 1086.C V1V2 (67% vs. 100%, P\textless 0.001; Pmag\textless 0.001). Although no significant univariate associations were observed between any T-cell or binding antibody response and HIV-1 acquisition, significant interactions were observed (multiplicity-adjusted P\textless=0.03). Among vaccinees with high IgG A244 V1V2 binding antibody responses, vaccine-matched CD4+ T-cell endpoints associated with decreased HIV-1 acquisition (estimated hazard ratios = 0.40-0.49 per 1-SD increase in CD4+ T-cell endpoint). Conclusions HVTN 702 and RV144 had distinct immunogenicity profiles. However, both identified significant correlations (univariate or interaction) for IgG V1V2 and polyfunctional CD4+ T-cells with HIV-1 acquisition.
@article{Moodie2022,
abstract = {Background The ALVAC/gp120 + MF59 vaccines in the HVTN 702 efficacy trial did not prevent HIV-1 acquisition. Vaccine-matched immunological endpoints that were correlates of HIV-1 acquisition risk in RV144 were measured in HVTN 702 and evaluated as correlates of HIV-1 acquisition. Methods Among 1893 HVTN 702 female vaccinees, 60 HIV-1-seropositive cases and 60 matched seronegative non-cases were sampled. HIV-specific CD4+ T-cell and binding antibody responses were measured 2 weeks post-fourth and fifth immunizations. Cox proportional hazards models assessed pre-specified responses as predictors of HIV-1 acquisition. Results The HVTN 702 Env-specific CD4+ T-cell response rate was significantly higher than in RV144 (63{\%} vs. 40{\%}, P = 0.03) with significantly lower IgG binding antibody response rate and magnitude to 1086.C V1V2 (67{\%} vs. 100{\%}, P{\textless} 0.001; Pmag{\textless} 0.001). Although no significant univariate associations were observed between any T-cell or binding antibody response and HIV-1 acquisition, significant interactions were observed (multiplicity-adjusted P{\textless}=0.03). Among vaccinees with high IgG A244 V1V2 binding antibody responses, vaccine-matched CD4+ T-cell endpoints associated with decreased HIV-1 acquisition (estimated hazard ratios = 0.40-0.49 per 1-SD increase in CD4+ T-cell endpoint). Conclusions HVTN 702 and RV144 had distinct immunogenicity profiles. However, both identified significant correlations (univariate or interaction) for IgG V1V2 and polyfunctional CD4+ T-cells with HIV-1 acquisition.},
author = {Moodie, Zoe and Dintwe, One and Sawant, Sheetal and Grove, Doug and Huang, Yunda and Janes, Holly and Heptinstall, Jack and {Laher Omar}, Faatima and Cohen, Kristen and {De Rosa}, Stephen C and Zhang, Lu and Yates, Nicole L and Sarzotti-Kelsoe, Marcella and Seaton, Kelly E and Laher, Fatima and Bekker, Linda Gail and Malahleha, Mookho and Innes, Craig and Kassim, Sheetal and Naicker, Nivashnee and Govender, Vaneshree and Sebe, Modulakgotla and Singh, Nishanta and Kotze, Philip and Lazarus, Erica and Nchabeleng, Maphoshane and Ward, Amy M and Brumskine, William and Dubula, Thozama and Randhawa, April K and Grunenberg, Nicole and Hural, John and Kee, Jia Jin and Benkeser, David and Jin, Yutong and Carpp, Lindsay N and Allen, Mary and D'Souza, Patricia and Tartaglia, James and DiazGranados, Carlos A and Koutsoukos, Marguerite and Gilbert, Peter B and Kublin, James G and Corey, Lawrence and Andersen-Nissen, Erica and Gray, Glenda E and Tomaras, Georgia D and McElrath, M Juliana},
doi = {10.1093/INFDIS/JIAC260},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Moodie et al. - 2022 - Analysis of the HVTN 702 Phase 2b-3 HIV-1 vaccine trial in South Africa assessing RV144 antibody and T-cell corre.pdf:pdf},
issn = {0022-1899},
journal = {The Journal of Infectious Diseases},
keywords = {fund{\_}not{\_}ack,original},
mendeley-tags = {fund{\_}not{\_}ack,original},
month = {jun},
number = {2},
pages = {246--257},
pmid = {35758878},
title = {{Analysis of the HVTN 702 Phase 2b-3 HIV-1 vaccine trial in South Africa assessing RV144 antibody and T-cell correlates of HIV-1 acquisition risk}},
url = {https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiac260/6618597},
volume = {226},
year = {2022}
}
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