EHVA P01/ANRS VRI08: A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults

EHVA P01 is an international, phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults.

开始日期2022-08-05

申办/合作机构

ANRS, Emerging Infectious Diseases

[+6]

NCT04120415 / Completed临床2期IIT

EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial 02)/ANRS VRI07: A Phase II Randomised, Placebo-controlled Trial of Vedolizumab With or Without Therapeutic HIV MVA Vaccine in Individuals Who Started Antiretrovirals During Primary or Chronic Infection

EHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication.

开始日期2022-06-21

申办/合作机构

ANRS, Emerging Infectious Diseases

[+14]

NCT04066881 / Enrolling by invitation临床2期IIT

A Phase IIb Three-arm, Two-stage HIV Prophylactic Vaccine Trial With a Second Randomisation to Compare TAF/FTC to TDF/FTC as Pre-exposure Prophylaxis

This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e. DNA/AIDSVAX (weeks 0,4,24,48) and DNA/CN54gp140 (weeks 0,4) + MVA/CN54gp140 (weeks 24,48) with placebo control. There will be a concurrent open-label 1:1 randomisation to compare daily TAF/FTC (week 0-26) to daily TDF/FTC (weeks 0-26) as pre-exposure prophylaxis.
The study aims to randomise up to 1668 eligible adults (18-40 years) through collaborating clinical research centres in 4 countries (Mozambique; South Africa; Tanzania; and Uganda). Each participant will be followed for a minimum of 74 weeks after enrolment.
The trial is designed to detect a reduction in HIV incidence that has public health relevance sufficient to justify implementation of the combination vaccine regimen. In light of the high level of effectiveness demonstrated in the PrEP trials (up to 86% reduction in HIV), this trial is powered to detect a protective vaccine efficacy of 70% at the final analysis.
The PrEP component will determine whether the effectiveness of TAF/FTC is unacceptably lower than the effectiveness of TDF/FTC.

开始日期2020-12-15

申办/合作机构

EuroVacc Foundation

[+10]

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项与 EuroVacc Foundation 相关的文献（医药）

2019-12-01·BMC Research Notes

Safety and tolerance of lymph node biopsies from chronic HIV-1 volunteers in rural Tanzania

Article

作者: Byakuzana, Theonestina ; Nyuri, Amina ; Pantaleo, Giuseppe ; Klimkait, Thomas ; Bani, Farida ; Masawa, Ngisi ; Daubenberger, Claudia ; Ding, Song ; Weisser-Rohacek, Maja ; Mkindi, Catherine Gerald ; Battegay, Manuel ; Orlova-Fink, Nina ; Marandu, Elias Antony

OBJECTIVEHIV-1 rapidly establishes a persistent infection that can be contained under life-long antiretroviral therapy (ART) but not cured. One major viral reservoir is the peripheral lymph node (LN) follicles. Studying the impact of novel HIV-1 treatment and vaccination approaches on cells residing in germinal centers is essential for rapid progress towards HIV-1 prevention and cure.RESULTSWe enrolled 9 asymptomatic adult volunteers with a newly diagnosed HIV-1 infection and CD4 T cell counts ≥ 350/ml. The patients underwent venous blood collection and inguinal lymph node excision surgery in parallel. Mononuclear cells were extracted from blood and tissues simultaneously. Participants were followed up regularly for 2 weeks until complete healing of the surgical wounds. All participants completed the lymph node excision surgery without clinical complications. Among the 9 volunteers, one elite controller was identified. The number of mononuclear cells recovered from lymph nodes ranged from 68 to 206 million and correlated positively with lymph node size. This is the first study to show that lymph node biopsy is a safe procedure and can be undertaken with local experts in rural settings. It provides a foundation for detailed immune response investigations during future clinical trials.

2019-11-01·Journal of Virology2区 · 医学

Correction for Kibler et al., “Replication-Competent NYVAC-KC Yields Improved Immunogenicity to HIV-1 Antigens in Rhesus Macaques Compared to Nonreplicating NYVAC”

2区 · 医学

Article

作者: Montefiori, David C. ; Forthal, Donald N. ; Ding, Song ; Roederer, Mario ; Gottardo, Raphael ; Barnett, Susan ; Jacobs, Bertram L. ; Foulds, Kathryn E. ; Ferrari, Guido ; Pantaleo, Giuseppe ; Wagner, Ralf ; Phogat, Sanjay ; Asbach, Benedikt ; Tartaglia, James ; Esteban, Mariano ; Galmin, Lindsey ; Self, Steve ; Parks, Robert ; Weiss, Deborah ; Heeney, Jonathan L. ; Cristillo, Anthony D. ; Stanfield-Oakley, Sherry ; Perdiguero, Beatriz ; Kibler, Karen V. ; García-Arriaza, Juan ; Yates, Nicole L. ; Tomaras, Georgia D. ; Seaman, Michael S.

Author(s): Kibler, Karen V; Asbach, Benedikt; Perdiguero, Beatriz; Garcia-Arriaza, Juan; Yates, Nicole L; Parks, Robert; Stanfield-Oakley, Sherry; Ferrari, Guido; Montefiori, David C; Tomaras, Georgia D; Roederer, Mario; Foulds, Kathryn E; Forthal, Donald N; Seaman, Michael S; Self, Steve; Gottardo, Raphael; Phogat, Sanjay; Tartaglia, James; Barnett, Susan; Cristillo, Anthony D; Weiss, Deborah; Galmin, Lindsey; Ding, Song; Heeney, Jonathan L; Esteban, Mariano; Wagner, Ralf; Pantaleo, Giuseppe; Jacobs, Bertram L | Abstract: Volume 93, no. 3, e01513-18, 2019, https://doi-org.libproxy1.nus.edu.sg/10.1128/JVI.01513-18. The article was originally published on 17 January 2019 with a standard copyright line (“© 2019 American Society for Microbiology. All Rights Reserved.”). We elected to pay for open access for the article after publication, necessitating replacement of the original copyright line with “© 2019 Kibler et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.” This change was made to the online version of the article on 21 August 2019.

2019-09-30·Journal of Clinical Investigation1区 · 医学

DNA priming and gp120 boosting induces HIV-specific antibodies in a randomized clinical trial

1区 · 医学

Article

作者: Rouphael, Nadine G ; Jensen, Ryan ; Li, Shuying S ; Montefiori, David C ; Wilson, Gregory J ; Pantaleo, Giuseppe ; Norwood, Aliza ; Sinangil, Faruk ; De Rosa, Stephen C ; Karuna, Shelly ; Morgan, Cecilia ; Sanchez, Brittany ; Ferrari, Guido ; Swann, Edith ; Maenza, Janine ; Tomaras, Georgia D ; Tieu, Hong-Van ; Sobieszczyk, Magdalena E ; Kobie, James ; Keefer, Michael C ; Frank, Ian ; McElrath, M Juliana ; Ding, Song

BACKGROUNDRV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODSOne hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTSAll regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final vaccination at high magnitude. While IgG3 responses were highest in T3, a lower IgA/IgG ratio was observed in T4. Binding antibodies persisted at 12 months in 35%-100% of participants. Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively. CD4+ T cell responses were detectable in all treatment groups (32%-64%) without appreciable CD8+ T cell responses.CONCLUSIONThe DNA/protein combination regimens induced high-magnitude and long-lasting HIV V1V2-binding antibody responses, and early coadministration of the 2 vaccines led to a more rapid induction of these potentially protective responses.TRIAL REGISTRATIONClinicalTrials.gov NCT02207920.FUNDINGNational Institute of Allergy and Infectious Diseases (NIAID) grants UM1 AI068614, UM1 AI068635, UM1 AI068618, UM1 AI069511, UM1 AI069470, UM1 AI069534, P30 AI450008, UM1 AI069439, UM1 AI069481, and UM1 AI069496; the National Center for Advancing Translational Sciences, NIH (grant UL1TR001873); and the Bill & Melinda Gates Foundation (grant OPP52845).

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