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Evaluating the Safety and Immune Response of a Prime-Boost HIV Vaccine Regimen in Healthy, HIV-Uninfected, Vaccinia-Naive Adults

NCT01571960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-10-15

No results posted yet for this study

Summary

This study will test the safety and immune responses of a prime-boost regimen of two HIV vaccines- a DNA vaccine followed by a modified vaccinia Ankara (MVA) vaccine- in healthy, HIV-uninfected, vaccinia-naive adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

GEO-D03 DNA vaccine

Either a 0.3-mg (Group 1: study vaccine) or 3-mg dose (Groups 2 and 3: study vaccine) administered as a 1-mL IM injection into the deltoid

BIOLOGICAL

MVA/HIV62B (MVA62B) vaccine

1 x 10\^8-TCID50 dose of MVA62B vaccine, administered as a 1-mL IM injection into the deltoid

BIOLOGICAL

Placebo for GEO-D03 DNA

Administered as a 1-mL IM injection into the deltoid

BIOLOGICAL

Placebo for MVA62B:

Administered as a 1-mL IM injection into the deltoid

Sponsors & Collaborators

  • GeoVax, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Susan Buchbinder · San Francisco Department of Public Health

  • Christine (Mhorag) Hay · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-08-31
Completion
2016-01-31

Countries

  • United States

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 NCT01571960 on ClinicalTrials.gov