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Immune Response to an HIV DNA Plasmid Vaccine Prime Followed by Adenovirus Boost in HIV-uninfected Individuals

NCT00955006 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-10-14

No results posted yet for this study

Summary

The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC-HIVDNA-016-00-VP

Composed of six DNA plasmids in equal concentrations that encode Gag, Pol, and Nef from clade B (strains HXB2, NL4-3, NY5/BRU) and the HIV-1 Env glycoproteins from clade A (strain 92rw020), clade B (strains HXB2/BaL), and clade C (strain 97ZA012). Vaccine will be administered intramuscularly (IM) in the deltoid via needle-free Biojector.

BIOLOGICAL

VRCHIVADV014-00-VP

A mixture of 4 recombinant serotype 5 adenoviral replication deficient vectors, each expressing HIV-1 proteins (clade B Gag-Pol fusion, clade A Env, clade B Env, clade C Env). Administered IM via needle and syringe.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Janine Maenza · Fred Hutchinson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-09-30
Completion
2017-11-22

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 NCT00955006 on ClinicalTrials.gov