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Safety of and Immune Response to Prime/Boost Vaccine Regimens in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adults

NCT00961883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-09-06

No results posted yet for this study

Summary

Investigators will examine the safety of and immune responses to two vaccines expressing synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who receive rAd5 first, and NYVAC-B later. A different dose of rAd5 will be tested in each group.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

NYVAC-B

New York Vaccinia (NYVAC) vector for HIV-1, delivered intramuscularly by injection at a dose of 1 x 10 \^7 PFU

BIOLOGICAL

Placebo

Sodium Chloride for injection, delivered intramuscularly

BIOLOGICAL

rAd5

Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10\^10 PFU

BIOLOGICAL

rAd5

Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10\^9 PFU

BIOLOGICAL

rAd5

Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10\^8 PFU

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • EuroVacc Foundation

    collaborator OTHER

  • HIV Vaccine Trials Network

    lead NETWORK

Principal Investigators

  • Giuseppe Pantaleo · CTU Lausanne

  • Pierre-Alexandre Bart, MD · Lausanne CRS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2013-01-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00961883 on ClinicalTrials.gov