Status: Recruitment ongoing, study in progress.
Number of volunteers: 80 healthy volunteers  at CHUV
Length of study: June 2009 - end of study estimated in December 2010

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.

Nber of
participants

0 (0)

1 (4)

5 (20)

6 (24)

1

30

2

NYVAC-B

Placebo

NYVAC-B

Placebo

Placebo

Placebo

rAd5 (1*10¹⁰)

Placebo

2

15

1

rAd5 (1*10⁸)

Placebo

Placebo

Placebo

NYVAC-B

Placebo

NYVAC-B

Placebo

3

15

1

rAd5 (1*10⁹)

Placebo

Placebo

Placebo

NYVAC-B

Placebo

NYVAC-B

Placebo

4

15

1

rAd5 (1*10¹⁰)

Placebo

Placebo

Placebo

NYVAC-B

Placebo

NYVAC-B

Placebo

Total

80 (75/5)

Cellular immune responses to yellow fever vaccine virus: a comprehensive functional characterization of
T-cell specific responses in vaccinees.

Status: recruitment closed; study in progress.
Number of volunteers: 50
Number of visits: 5

In the Framework of an HIV vaccine development, more knowledge on correlates of protection of current successful viral vaccines is needed.

Yellow fever immunization with vaccine strain YF-17D is a classic example of a safe and efficient live attenuated vaccine. A single dose induces a durable protection due to neutralizing antibodies and YF-specific T cell responses.

Antibody response to YF-17D virus has been well characterized and shown to be a major component of the effectiveness of the vaccine, however, cell-mediated immunity induced by 17D virus is still poorly understood. Only recently, microarray technology has been successfully used to study cellular responses to YF-17D virus, leading to the identification of genes implicated in different immune pathways.

This study’s purpose is to contribute in understanding better the complexity of the T-cell response induced by YF-17D immunization.

The recruitment for this study took place at the Travel Medicine Consultation from the Policlinique Médicale Universitaire (PMU) at Lausanne and consisted of healthy adult travelers in need of yellow fever vaccination for their trip to South American or African countries. Following this first visit, 4 follow-up visits are performed at the Vaccine and Immunotherapy Center (VIC) in a length of  15 months.

Standardization and Validation of immunologic assays, and evaluation of the specific T cells immune response to different viruses.

Status: continuously recruiting
Number of volunteers: 50
Number of visits: 1 or 2

The goal of this study is to carry out a systematic study of the immune response against viruses that are very widespread and generally well-controlled like the CMV (Cyto MegaloVirus), and the EBV (Epstein Barr Virus), in order to better understand which parameters are involved in the effective control of these viruses and to identify the defective parameters of the immune response against HIV.

This study involves either a blood draw, see information sheet for blood draw , or a leukapheresis, preceded by a screening visit a few days before, please see information sheet for leukapheresis (in French).