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Cited by 336

The DOI matches its Crossref record; 30 of the 30 references it cites were found in a registry or an index.

Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)

Open access
Barouch, Dan H, Tomaka, Frank L, Wegmann, Frank, Stieh, Daniel J, Alter, Galit, Robb, Merlin L, Michael, Nelson L, Peter, Lauren, Nkolola, Joseph P, Borducchi, Erica N, Chandrashekar, Abishek, Jetton, David, Stephenson, Kathryn E, Li, Wenjun, Korber, Bette, Tomaras, Georgia D, Montefiori, David C, Gray, Glenda, Frahm, Nicole, McElrath, M Juliana, Baden, Lindsey, Johnson, Jennifer, Hutter, Julia, Swann, Edith, Karita, Etienne, Kibuuka, Hannah, Mpendo, Juliet, Garrett, Nigel, Mngadi, Kathy, Chinyenze, Kundai, Priddy, Frances, Lazarus, Erica, Laher, Fatima, Nitayapan, Sorachai, Pitisuttithum, Punnee, Bart, Stephan, Campbell, Thomas, Feldman, Robert, Lucksinger, Gregg, Borremans, Caroline, Callewaert, Katleen, Roten, Raphaele, Sadoff, Jerald, Scheppler, Lorenz, Weijtens, Mo, Feddes-de Boer, Karin, van Manen, Daniëlle, Vreugdenhil, Jessica, Zahn, Roland, Lavreys, Ludo, Nijs, Steven, Tolboom, Jeroen, Hendriks, Jenny, Euler, Zelda, Pau, Maria G, Schuitemaker, Hanneke·2018·The Lancet
DOI 10.1016/s0140-6736(18)31364-3
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Abstract

BACKGROUND Over 1.8 million new cases of HIV-1 infection were diagnosed worldwide in 2016. No licensed prophylactic HIV-1 vaccine exists. METHODS This randomized, double-blinded, placebo-controlled phase I/IIa clinical trial evaluated the safety and immunogenicity of adenovirus serotype 26 (Ad26) vector-based HIV-1 vaccine regimens in 393 participants in Eastern Africa, South Africa, Thailand and the United States. Participants were randomly assigned to treatment groups based on a computer-generated randomization code. Vaccine regimens included priming with Ad26 vectors expressing mosaic Env/Gag/Pol antigens and boosting with Ad26 or MVA vectors expressing these antigens with or without aluminum adjuvanted clade C Env gp140 protein. A parallel study in 72 rhesus monkeys assessed the immunogenicity and protective efficacy of these vaccine regimens against repetitive, heterologous, intrarectal challenges with simian-human immunodeficiency virus (SHIV-SF162P3). RESULTS All vaccine regimens demonstrated favorable safety and tolerability. The mosaic Ad26 prime/Ad26+gp140 boost vaccine was the most immunogenic in humans; it elicited Env-specific binding antibody responses, antibody-dependent cellular phagocytosis responses, and T-cell responses in 100%, 80% and 83% of vaccine recipients, respectively. This vaccine regimen induced similar magnitude, durability, and phenotype of immune responses in rhesus monkeys and afforded 66% protection against acquisition of infection following a series of six SHIV-SF162P3 challenges. Env-specific ELISA and ELISPOT responses were the principal immune correlates of protection against SHIV challenge in monkeys. CONCLUSIONS The mosaic Ad26/Ad26+gp140 HIV-1 vaccine induced comparable and robust immune responses in humans and rhesus monkeys, and it provided significant protection against heterologous SHIV challenges in monkeys. This vaccine regimen is currently being evaluated in a phase IIb clinical efficacy study in sub-Saharan Africa.

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Metadata

Authors
Barouch, D. H., Tomaka, F. L., Wegmann, F., Stieh, D. J., Alter, G., Robb, M. L., Michael, N. L., Peter, L., Nkolola, J. P., Borducchi, E. N., Chandrashekar, A., Jetton, D., Stephenson, K. E., Li, W., Korber, B., Tomaras, G. D., Montefiori, D. C., Gray, G., Frahm, N., McElrath, M. J., Baden, L., Johnson, J., Hutter, J., Swann, E., Karita, E., Kibuuka, H., Mpendo, J., Garrett, N., Mngadi, K., Chinyenze, K., Priddy, F., Lazarus, E., Laher, F., Nitayapan, S., Pitisuttithum, P., Bart, S., Campbell, T., Feldman, R., Lucksinger, G., Borremans, C., Callewaert, K., Roten, R., Sadoff, J., Scheppler, L., Weijtens, M., Feddes-de Boer, K., van Manen, D., Vreugdenhil, J., Zahn, R., Lavreys, L., Nijs, S., Tolboom, J., Hendriks, J., Euler, Z., Pau, M. G., & Schuitemaker, H.
Venue
The Lancet
Publisher
Elsevier BV
Published
2018-07
Volume
392
Issue
10143
Pages
232-243
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(18)31364-3
OpenAlex
W2825912598
Cited by
336
References
30
FWCI
20.83
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). https://app.cochat.ai/papers/10.1016/s0140-6736(18)31364-3
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Barouch, D. H., Tomaka, F. L., Wegmann, F., Stieh, D. J., Alter, G., Robb, M. L., Michael, N. L., Peter, L., Nkolola, J. P., Borducchi, E. N., Chandrashekar, A., Jetton, D., Stephenson, K. E., Li, W., Korber, B., Tomaras, G. D., Montefiori, D. C., Gray, G., Frahm, N., . . . Schuitemaker, H. (2018). Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). The Lancet. https://doi.org/10.1016/s0140-6736(18)31364-3

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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