Preventive experimental HIV vaccine trials

HVTN 084

FAQ - Questions and Answers 

Status: Study completed
Number of volunteers: 100 healthy volunteers
Length of study: June 2011 – end of study estimated in June 2012

A double-blinded, randomized phase IB trial aimed at studying the incidence of antigenic competition on the immunogenicity of Gag/Pol for HIV-1: a comparison between rAd5 gag/pol Env A/B/C and rAd5 gag/pol.

The Vaccine and Immunotherapy Center (VIC) has a large experience in testing of preventive vaccines against HIV.

This phase IB clinical trial is designed to evaluate the safety and to compare the immune response induced by vaccine-type adenovirus (rAd5), which affect about 50% of the Swiss population.

25 volunteers at low risk of HIV infection, aged 18-50 years, men (circumcised) and women, will be enrolled at the Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, for a period of 6 months. A total of 5 visits are scheduled including a full medical check-up, a single immunization visit and 3 follow-up visits with blood samples.

This clinical study is coordinated by the HIV Vaccine Trials Network (HVTN) and funded by the National Institutes of Health (NIH).

For further information on this study, please contact us by phone +41 21 314 1160 / +41 21 314 1163.

HVTN 078

Status: Study completed
Number of volunteers: 80 healthy volunteers at CHUV
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Length of study: June 2009 – end of study October 2012

​​​​​​​A phase IB clinical trial to evaluate the safety and immunogenicity of heterologous prime/boost vaccine regimens (NYVAC-B/rAd5 vs. rAd5/NYVAC-B) in healthy, HIV-1 uninfected, Ad5 seronegative adult participants.

The aim of this phase IB clinical trial is to evaluate the safety of heterologous prime/boost vaccine regimens against HIV (NYVAC-B/rAd5 vs rAd5/NYVAC-B) in HIV-1 seronegative individuals and to compare the immune response induced by each of those vaccination regimens. In the rAd5/NYVAC-B regimen, 3 doses of rAd5 will be explored. The doses of NYVAC and rAd5, as well as the vaccination schedule, are based on data from previous pre-clinical and clinical trials.

80 healthy HIV seronegative volunteers, male or female, between 18 and 45 years old, will be enrolled at the Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland, for 12 months. They will be randomized into one of the 4 groups outlined below, some of which will receive the vaccine regimen (75), and others the placebos only (5).

The study is funded by the Division of AIDS from the US National Institutes of Health and sponsored by the Eurovacc Foundation based in Lausanne, Switzerland. The HIV Vaccine Trials Network (HVTN) will coordinate this study.

For further information on this study, please contact us by phone +41 21 314 1160 / +41 21 314 1163.

EV02

Status: Study completed
Number of volunteers: 40 healthy volunteers (25 at CHUV, 15 at the St Mary's Hospital, London, UK)
Length of study: February 2005 – March 2006

A phase I trial to assess the safety and immunogenicity of two experimental HIV vaccines when administered alone (NYVAC-C) or in combination (DNA-C + NYVAC-C) in healthy volunteers at low risk of HIV infection.

​​​​​​​The trial enrolled 40 healthy volunteers, 25 at the CHUV, in Lausanne, and 15 at Saint Mary’s Hospital from the Imperial College in London. The EuroVacc Foundation was the sponsor of this study.

Vaccination schedule
Week 0Week 4Week 20Week 24
Group 1N = 20DNA-CDNA-CNYVAC-CNYVAC-C
Group 2N = 20NYVAC-CNYVAC-C

Results: Here is an article about the study results published by the VIC staff in the Journal of Experimental Medicine, on January 15th 2008:

For further information on this study, please contact us by phone +41 21 314 1160 / +41 21 314 1163.

EV03/ANRSVAC20

Status: Study completed
Number of volunteers: 147 healthy volunteers (38 at CHUV)
Length of study: June 2007 - October 2009

A phase I/II trial to compare the immunogenicity and safety of 3 DNA-C prime followed by 1 NYVAC-C boost to 2 DNA-C prime followed by 2 NYVAC-C boost in healthy volunteers, at low risk of HIV infection.

​​​​​​​These vaccines are based on an HIV subtype, which is prevalent in China, India and sub-Saharan Africa, and constitutes more than 50% of the new HIV infections worldwide. The recruitment involves 147 volunteers from 4 countries (Germany, Switzerland, UK and several sites in France). The EuroVacc Foundation acts as the sponsor for the sites in Germany, Switzerland and UK, and the Agence Nationale de Recherche sur le Sida (ANRS) acts as sponsor for the French sites, and Legal Representative of the EuroVacc Foundation in the European Union member states.

Vaccination schedule
Week 0Week 4Week 8Week 20Week 24
Group 1N = 70DNA-CDNA-CDNA-CNYVAC-C
Group 2N = 70DNA-CDNA-CNYVAC-CNYVAC-C
IAVI 011

Status: Study completed
Number of volunteers: 111 healthy volunteers (26 at CHUV)
Length of study: November 2003 – September 2005

A randomized, placebo-controlled, dosage-escalating phase 1 study, double-blinded with respect to assignment to either vaccine or placebo, to evaluate the safety and immunogenicity of a modified vaccinia virus ankara vaccine containing the clade A HIV-1 gag gene, (MVA.HIVA) vaccine administered by three different routes and at three different dosage levels in HIV-uninfected, healthy volunteers.

For this study, 111 volunteers were enrolled on 5 sites (two in South Africa, one in the UK, one in the Netherlands and one in Switzerland). The VIC enrolled 26 volunteers. The study was organized by the International Aids Vaccine Initiative - (IAVI), which is an international non-profit organization, whose mission is to develop a preventive vaccine, safe and immunogenic against HIV.

Resullts: The first results from previous studies involving the same vaccine products (IAVI 006 and IAVI 009) showed very weak immune responses. Thus the decision was taken to discontinue administering small and medium doses of the same vaccine product. In the IAVI 010 protocol, bigger doses of the vaccine product were administered. This study had already begun prior to IAVI 011, and it was decided to evaluate the immunogenicity of the stronger dose only in the first study. As a result, IAVI 011 was discontinued.

For further information on this study, please contact us by phone +41 21 314 1160 / +41 21 314 1163.

EV01

Status: Study completed
Number of volunteers: 24 healthy volunteers (12 at CHUV, 12 at the St Mary Hospital, London UK)
Length of study: August 2003 – August 2004

EuroVacc 01 was a phase I study to evaluate the safety of the NYVAC-C vaccine in healthy volunteers at low risk of HIV infection. The NYVAC-C vaccine was developed by the European consortium EuroVacc, financed by the 5th framework program of the European Union. 24 volunteers were enrolled, 12 in London at Saint Mary’s Hospital, and 12 at the VIC. The main goal of the study was to evaluate the safety and the immunogenicity of the NYVAC-C.

For further information on this study, please contact us by phone +41 21 314 1160 / +41 21 314 1163.

Contact

Division of Immunology and Allergy
Monday to Friday: 8 am - 6 pm
Vaccine and Immunotherapy Center
1011 Lausanne, Suisse
Tél. +41 21 314 1160
Tél. +41 21 314 1163
Fax +41 21 314 1161
 Dernière mise à jour le 28/06/2019 à 08:09