NCT01435135

Randomized, Double Blind Evaluation of Late Boost Strategies for HIV-uninfected Participants in the HIV Vaccine Efficacy Trial RV 144: "Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults"

Status unknown Phase 2 Last updated 2 November 2020

What this trial tests

Phase 2 trial testing ALVAC-HIV in HIV Infections in 162 participants. Status unknown.

Timeline

1 April 2012

Primary endpoint
1 July 2021

1 July 2021

Quick facts

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	162
Start date	1 April 2012
Primary completion	1 July 2021
Estimated completion	1 July 2021
Sites	2 locations across Thailand

Drugs / interventions tested

• ALVAC-HIV — full drug profile →
• AIDSVAX B/E — full drug profile →
• ALVAC-HIV Placebo
• AIDSVAX B/E Placebo

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

U.S. Army Medical Research and Development Command

Who can join

18 and older, any sex, with HIV Infections. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Primary Immunogenicity Endpoint
  Time frame: Week 0
  Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
• Safety Endpoints
  Time frame: During the 3 days post-vaccination
  Post-vaccination reactions including erythema, induration, pain/tenderness, swelling, limitation of arm movement, fever, tiredness, chills, myalgia, arthralgia, headache, nausea, dizziness, and rash will be assessed and recorded on diary cards.
• Primary Immunogenicity Endpoint
  Time frame: Week 2
  Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
• Primary Immunogenicity Endpoint
  Time frame: Week 24
  Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
• Primary Immunogenicity Endpoint
  Time frame: Week 26
  Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
• Primary Immunogenicity Endpoint
  Time frame: Week 48
  Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.

Sponsor's own description

The purpose of this study is to assess safety and tolerability of late boost regimens of AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected participants from RV 144.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Major Scientific Hurdles in HIV Vaccine Development: Historical Perspective and Future Directions.
   Ng'uni T, Chasara C, Ndhlovu ZM. · · 2020 · cited 101× · PMID 33193428 · DOI 10.3389/fimmu.2020.590780
2. Antibody persistence and T-cell balance: two key factors confronting HIV vaccine development.
   Lewis GK, DeVico AL, Gallo RC. · · 2014 · cited 76× · PMID 25349379 · DOI 10.1073/pnas.1413550111
3. Principles of Immunotherapy: Implications for Treatment Strategies in Cancer and Infectious Diseases.
   Naran K, Nundalall T, Chetty S, Barth S. · · 2018 · cited 71× · PMID 30622524 · DOI 10.3389/fmicb.2018.03158
4. Progress in HIV vaccine development.
   Hsu DC, O'Connell RJ. · · 2017 · cited 62× · PMID 28281871 · DOI 10.1080/21645515.2016.1276138
5. RNA interference approaches for treatment of HIV-1 infection.
   Bobbin ML, Burnett JC, Rossi JJ. · · 2015 · cited 61× · PMID 26019725 · DOI 10.1186/s13073-015-0174-y
6. New concepts in HIV-1 vaccine development.
   Stephenson KE, D'Couto HT, Barouch DH. · · 2016 · cited 58× · PMID 27268856 · DOI 10.1016/j.coi.2016.05.011
7. Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial.
   Rerks-Ngarm S, Pitisuttithum P, Excler JL, Nitayaphan S, et al · · 2017 · cited 53× · PMID 28329190 · DOI 10.1093/infdis/jix099
8. Late boosting of the RV144 regimen with AIDSVAX B/E and ALVAC-HIV in HIV-uninfected Thai volunteers: a double-blind, randomised controlled trial.
   Pitisuttithum P, Nitayaphan S, Chariyalertsak S, Kaewkungwal J, et al · · 2020 · cited 38× · PMID 32035516 · DOI 10.1016/s2352-3018(19)30406-0