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A Phase IIA Trial to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Followed by an MVA HIV-1 Vaccine in HIV-uninfected Volunteers

NCT01371175 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2011-06-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.

Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of up to 10% (approximately 10 additional volunteers) will be permitted in the study.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA.HIVA

0.5mg DNA.HIVA or placebo

BIOLOGICAL

MVA.HIVA

5x10\^6 pfu MVA or placebo

BIOLOGICAL

MVA.HIVA

5x10\^7 pfu MVA or placebo

BIOLOGICAL

MVA.HIVA

2.5x10\^8 pfu MVA or placebo

Sponsors & Collaborators

  • Medical Research Council-Oxford

    collaborator UNKNOWN

  • University of Nairobi

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Barry S. Peters, MD · Guys and St. Thomas' Hospital

  • Walter Jaoko · KAVI (Kenya AIDS Vaccine Initiative)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2005-05-31

Countries

  • Kenya
  • United Kingdom

Study Locations

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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 NCT01371175 on ClinicalTrials.gov