Ongoing studies

HIV PREVENTION CLINICAL TRIAL

HVTN 704 / HPTN 085 or AMP Study

Design: Multicenter, randomized, controlled, double-blind trial
Status: Study in progress
Length of the study: 21 months

A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection among men and transgender persons who have sex with men.

70 men and transgender persons who have sex with men, in good health, HIV-uninfected and aged 18-50 years old will be enrolled at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne for 21 months with monthly visits. Participants will receive 10 IV infusions (containing either the antibody or a placebo) and will have follow-up visits including blood sampling.

For further information on this study, please contact us by phone +41 21 314 11 60 / +41 21 314 11 63.

HVTN 127 / HPTN 187

Design: Multicenter, randomized, partially blinded trial
Status: Study in progress
Length of the study per participant: 112 weeks
Estimated study completion date: 31 July 2021

The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults (118-50 years).

Participants will attend numerous study visits throughout the course of the study, beginning at Week 0 through Week 112. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires.

For more detailed information on the study, please consult www.clinicaltrials.gov and search for “HVTN127”

HIV TREATMENT CLINICAL TRIAL

EHVA T02

Design: Multicenter, randomized, double-blinded trial
Status: Recruitment not yet open
Length of the study per participant: up to 54 weeks
Estimated study completion date: 31 December 2021

Study title: A Phase I/II Randomised Therapeutic HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection

EVHA T01 is an international, phase I/II, multicentre, multi-stage, double-blind study that will evaluate at least three experimental arms compared to placebo control in HIV-1 infected participants to see if one or more has a clinically relevant impact on the control of viral replication.

For more detailed information on the study, please consult www.clinicaltrials.gov and search for “EHVAT01”

OUR PARTNERS

SVRI

CHUV

NIH

Bill & Melinda Gates Foundation

HVTN

Non-interventional Research Project

Swiss Immune Setpoint Study

Design: Observational
Status: Study in progress
Length of the study per participant: 1 clinic visit
Estimated study completion date: December 2021

The Immune Setpoint study is an observational study of 600 healthy volunteers, stratified by age and gender including a subset of individuals who will receive the yellow fever vaccination (YFV). The study is conducted at the Vaccine and Immunotherapy Centre (VIC) CHUV, Lausanne and the University of Zurich Travel clinic.

The study objectives are:

To investigate a large number of phenotypic and functional parameters (about 200) of innate and adaptive immunity
To identify the Immune Setpoint in healthy individuals through:
- Validated and highly specific immunological markers defining phenotypic and functional distinct cell populations with assays of high-level reproducibility suitable for clinical monitoring
- Immunological markers shared by different cell types
- Exploratory markers

To evaluate the impact of vaccination (notably YF and influenza vaccination) on the immune system
To determine the relationship between the microbiome and the Immune Setpoint

Collaborations:

STOP-FLU - Reducing the Burden of Influenza after Solid-Organ Transplantation:
Design: Prospective double-blinded randomized controlled three-arm parallel group superiority multicenter trial.
Status: Recruiting and ongoing.

Influenza is associated with significant morbidity and mortality in solid-organ transplant (SOT) recipients and it is mainly prevented by seasonal influenza vaccination. Unfortunately, the immunogenicity of standard influenza vaccine is suboptimal in this population. Vaccination with a high-dose (HD) influenza vaccine or an MF59-adjuvanted (MF59a) vaccine have significantly reduced the incidence of influenza and increased the immunogenicity of influenza vaccine in the elderly. The investigators will compare the immunogenicity and efficacy of two new vaccination strategies, consisting in vaccination with a HD influenza vaccine or an MF59a influenza vaccine, to the standard-dose non-adjuvanted vaccination (standard of care) in a population of SOT recipients.

The Vaccine and Immunotherapy Centre is providing operational support for the STOP-FLU clinical trial