Status: Study completed
Number of volunteers: 5
Length of the study: 2 visits (1h and 3h)

Characterization of the T immune response (T lymphocytes) in HIV seropositive patients with classic evolution and in Long Term Non Progressors (LTNP) patients.

This study is part of HIV research and aims to better understand mechanisms which enable Long Term Non Progressors (LTNP) patients to control the infection. In order to know more about these control mechanisms, some comparison of the immune response between classic evolution patients and LTNP patients should be done. These immune response analyses are handled on a cell population called T lymphocytes from the blood. The lymphocytapheresis technique enables to collect a large number of cells (4 to 10 billion of cells) with a small amount of blood (100mL). These cells will be used in order to perform analyses to better understand these patients immune response. Moreover, these study results may contribute to the development of new HIV vaccine strategies.    

For this study, we are recruiting HIV infected patients, aged between 18 and 60 years.

For further information on this study, please consult these information sheets (in French):

• Information sheet 1 ·(165 Kb) - HIV seropositive patients with classic evolution
• Information sheet 2 ·(151 Kb) - Long Term Non Progressors (LTNP) patients

Status: Study completed
Number of volunteers: 50
Number of visits: 5

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

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.

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 on 021 314 11 60/63.

Status: Study completed
Number of volunteers: 80 healthy volunteers  at CHUV
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.

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.

Group 1

N = 20

DNA-C

DNA-C

NYVAC-C

NYVAC-C

Group 2

N = 20

NYVAC-C

Results: Here is an article about the study results published by the VIC staff in the Journal of Experimental Medicine, on January 15^th 2008: <An HIV-1 clade C DNA prime, NYVAC boost vaccine regimen induces reliable, polyfunctional, and long-lasting T cell responses. Alexandre Harari et al.

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.

Group 1

N = 70

DNA-C

DNA-C

DNA-C

NYVAC-C

Group 2

N = 70

DNA-C

DNA-C

NYVAC-C

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.

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 5^th 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.

Status: Study completed
Number of volunteers: 10 HIV positive patients
Length of study: May 2006 – June 2007

The TheraVac study program for the “Evaluation of a new therapeutic vaccination strategy for HIV infection” is funded by the European Union and involves several research laboratories. The working hypothesis of this program is that a combination of a new and potent HIV vaccine with HAART should restore a protective immune control of HIV that would allow limiting drug toxicity by prolonging the time without antiretroviral therapy. The first step of this clinical program consisted of 2 single center phase 1 clinical trial with identical design to evaluate the safety of this new therapeutic strategy, that combines HAART with a new HIV recombinant poxvirus vaccine (NYVAC-B for TheraVac 01 performed at the CHUV and MVA-B for TheraVac 02 performed in the Netherlands).

TheraVac 01 took place at the Vaccine and Immunotherapy Center (VIC) and enrolled 10 patients, infected by HIV-B, and treated successfully with HAART since at least 6 months.

The study was an open-label phase I study to evaluate the safety of the HIV-1 vaccine NYVAC-B.

TheraVac 02 took place in The Netherlands, at the Academic Medical Center of Amsterdam.

Status: Study completed
Number of volunteers: 30
Number of visits: 1 or 2

Study on the impact of a soluble molecule agonist CD40 on the quality of the immune T response with a view to elaborate a vaccination strategy against HIV.

A majority of healthy adults (80-90%) carry viruses such as the Cytomegalovirus (CMV), the Epstein-Barr Virus (EBV) and the Herpes Simplex Virus (HSV). Some cells from the immune system, of which the T memory cells, have developed to some parts of these viruses, called antigens, a response sufficiently strong to be detected directly ex vivo. Also, many individuals’ memory T cells have developed this same type of responses against the tetanus vaccination. T cells coming from subjects with such a response are an ideal model for the study of the capacity of new molecules to enhance the immune T response. The T cells are isolated from the white blood cells. The response of these cells against viral antigens derived from CMV, EBV and HSV, and against the tetanos toxin are assessed with or without the presence of the sCD40L agonist soluble of CD40.

Status: Study completed
Number of volunteers: 100
Lenght of the study: 1 month

Immunogenicity (humoral and cellular immune responses) and safety of the Northern Hemisphere 2012 – 2013 seasonal flu vaccine in patients 65 year old

The aim of this study is to investigate the effects of aging on the immune system. Particularly, it aims to assess the effect of the seasonal flu vaccine in order to improve recommendations in elderly and to better understand the immune system functioning.

100 healthy volunteers, men and women, aged 65 years old will be enrolled in this study for 1 month. A total of 5 visits are scheduled including a check-up, one immunization visit and 3 follow-up visits including blood samples.  

If you plan to get vaccinated against flu and you are 65 years old or more, you could be interested by this study!

For further information on this study, please consult the information sheet (in French - 265 Ko) and contact us by phone 021 314 11 60 / 63.

Status: Study completed
Number of volunteers: 70
Number of visits: 12

A Phase I  Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of BCG and AERAS-404 Administered as a Prime-Boost Regimen to HIV-Negative, TB-Negative, BCG-Naive Adults

BCG is currently the only licensed vaccine for the prevention of tuberculosis. The incomplete protection of this vaccine, especially in adults, makes it necessary to develop an effective booster in order to increase protection from TB disease.

The aim of this study is to assess the safety and the efficiency of BCG and a AERAS-404 two- or three-dose boost regimen administrated to healthy adults. 70 volunteers will be enrolled at the vaccine and immunotherapy Center, CHUV (Beaumont Hospital) for 10 months.

For this study, we have recruited 18-50 years old women and men in good health and who didn’t get BCG vaccination.

For additional information, please contact us by phone 021 314 11 63.

Status: Study completed
Number of volonteers: 48 (4 groups of 12 volunteers)
Number of visits: 13 or 15 (depending on the group number)

A Phase I randomized placebo-controlled study of a virosome-formulated anti-Candida vaccine (PEV7) administered by the vaginal or intramuscular route to healthy adult volunteers

The aim of PCAN001 study is to develop a preventive vaccine against the yeast Candida in order to treat and prevent the vaginal infections due to Candida albicans (vaginal mycosis).

Two objectives have been defined for this study: the first one is the evaluation of the safety and the tolerability of the vaccine and the second one is the determination of the immune response induced by this vaccine. Two types of immunisation ways will be tested and compared (intramuscular injections or intravaginal administration) over a period of 15 months.

For this study, we are recruiting 18-45 years old women in good health and under oral contraceptive (pill).

For further information on this study, please consult the information sheet (in French - 260 Ko)

Status: Study completed
Number of volunteers: 40
Lenght of the study: 1 month

Study of the immune response to vaccination against seasonal flu in different groups of age

The aim of this study is to compare and to assess the effect of aging on the immune system, in the context of the vaccination against seasonal flu.

40 healthy volunteers, men and women, aged 45-65 years old will be enrolled in this study for 1 month. A total of 5 visits are scheduled including a short check-up, one baseline visit (of note: for CHUV employees, the vaccination could be performed at the health care medicine) and 3 follow-up visits including blood samples.  

If you plan to get vaccinated against flu and you are 45-65 years old, you could be interested by this study!

For further information on this study, please consult the information sheet (in French - 98.6 Ko) and contact us by phone 021 314 11 60 / 63.