HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants

October 13, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. This study will evaluate the safety and immunogenicity of an experimental multiclade HIV vaccine, VRC-HIVDNA016-00-VP, followed by a similarly structured adenovirus-vectored vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adults. The DNA plasmids in both the vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. Participants in this study will be recruited in North America, South America, and Africa.

Each volunteer will participate in the study for 36 months. Participants will be randomly assigned to one of two groups. Group 1 participants will receive the DNA HIV vaccine at study entry and at Months 1 and 2. At Month 6, Group 1 participants will receive an injection of the adenoviral vector HIV vaccine. Group 2 participants will receive placebo at study entry and Months 1, 2, and 6. There will be 17 study visits, which will occur at study entry and every 2 weeks thereafter until Day 70; at Month 6 and every 2 weeks thereafter until Day 210; and Months 9.5, 12, 18, 24, 30, and 36. A physical exam, adverse events reporting, HIV and pregnancy prevention counseling, and medication history will occur at each visit. Blood and urine collection will occur at selected visits.

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Projeto Praca Onze/Hesfa Crs
      • San Paulo, Brazil
        • Sao Paulo HVTU - CRT DST/AIDS CRS
  • Haiti
      • Port-au-Prince, Haiti
        • Les Centres GHESKIO CRS
  • Jamaica
      • Kingston, Jamaica
        • Epidemiology Research & Training Unit Jamaica MOH CRS
  • South Africa
      • Cape Town, South Africa
        • Emavundleni Desmond Tutu HIV Centre CRS
      • Klerksdorp, South Africa
        • CAPRISA Aurum CRS
    • Gauteng
      • Johannesburg, Gauteng, South Africa
        • Soweto HVTN CRS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2041
        • Alabama Vaccine CRS
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Project Brave HIV Vaccine CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp. CRS
    • Rhode Island
      • Providence, Rhode Island, United States, 02115
        • Miriam Hospital's HVTU
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Vaccine CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV uninfected
  • Has access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
  • Willing to receive HIV test results
  • Good general health
  • Willing to use acceptable forms of contraception
  • Completed at least 12 years of schooling (South African participants only)

Exclusion Criteria:

  • HIV vaccines in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first study vaccine administration
  • Blood products within 120 days prior to first study vaccine administration
  • Immunoglobulin within 60 days prior to first study vaccine administration
  • Live attenuated vaccines within 30 days prior to first study vaccine administration
  • Investigational research agents within 30 days prior to first study vaccine administration
  • Subunit or killed vaccines within 14 days prior to first study vaccine administration
  • Current tuberculosis prophylaxis or therapy
  • Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
  • Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
  • Any job-related responsibility that would interfere with the study
  • Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection
  • Unstable asthma
  • Diabetes mellitus type 1 or 2
  • Thyroid disease requiring treatment
  • Serious angioedema within the past 3 years
  • Uncontrolled hypertension
  • Bleeding disorder
  • Cancer. If a participant has had surgery to remove the cancer and, in the opinion of the investigator, the cancer is not likely to recur during the study period, the participant is not excluded.
  • Seizure disorder
  • Asplenia
  • Mental illness that would interfere with compliance with the protocol
  • Other conditions that, in the judgment of the investigator, would interfere with the study
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
DNA HIV vaccine administered at study entry and at Months 1 and 2 and adenoviral vector HIV vaccine administered at Month 6
Biological: VRC-HIVDNA016-00-VP
4 mg administered in deltoid
Other Names:
  • Multiclade HIV-1 DNA Plasmid Vaccine
Biological: VRC-HIVADV014-00-VP
1 x 10^10 PU administered in deltoid
Other Names:
  • rAD
Placebo Comparator: 2
DNA HIV vaccine placebo administered at study entry and at Months 1 and 2 and adenoviral vector HIV vaccine placebo administered at Month 6
Biological: VRC-HIVDNA016-00-VP placebo
1 mL administered at study entry and Months 1 and 2
Other Names:
  • Phosphate buffered saline
  • DNA HIV placebo vaccine
Biological: VRC-HIVADV014-00-VP placebo
1 mL administered at Month 6
Other Names:
  • VRC-DILUENT013-DIL-VP
  • rAD placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local and systemic adverse reactions
Time Frame: Measured after each injection and for 12 months after the first injection
Measured after each injection and for 12 months after the first injection
Unfractionated IFN-γ ELISpot responses to HIV-1 peptide pools as performed by the VRC laboratory
Time Frame: Measured at Day 196
Measured at Day 196
Unfractionated IFN-γ ELISpot responses to HIV-1 peptide pools as performed by the FHCRC laboratory
Time Frame: Measured at Day 210
Measured at Day 210
CD4 and CD8 T cell responses to HIV-1 peptide pools as measured by flow cytometry-based intracellular cytokine staining (ICS) assay as performed by the VRC laboratory
Time Frame: Measured at Day 196
Measured at Day 196
CD4 and CD8 T cell responses to HIV-1 peptide pools as measured by flow cytometry-based ICS assay as performed by the FHCRC laboratory
Time Frame: Measured at Day 210
Measured at Day 210

Secondary Outcome Measures

Outcome Measure
Time Frame
Humoral immune response to HIV-1 as measured by neutralizing antibody and binding assays
Time Frame: Measured through Month 36
Measured through Month 36
Unfractionated IFN-γ ELISpot responses to HIV-1 as performed by the FHCRC or the VRC laboratories
Time Frame: Measured at Days 70, 210, and 364
Measured at Days 70, 210, and 364
CD4 and CD8 T cell responses to HIV-1 as measured by flow cytometry-based ICS assay as performed by the FHCRC or the VRC laboratories
Time Frame: Measured at Days 70, 210, and 364
Measured at Days 70, 210, and 364
Vaccine-induced HIV-specific T cell responses to individual peptide pools as measured by IFN-γ ELISpot and ICS as performed by the FHCRC or the VRC laboratories
Time Frame: Measured through Month 36
Measured through Month 36
Cross-clade cellular immune responses to HIV-1 Gag-Pol-Nef peptides from clades A and C as assessed by IFN-γ ELISpot and ICS assays as performed by the FHCRC or the VRC laboratories
Time Frame: Measured through Month 36
Measured through Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Gavin Churchyard, MBBCh, FCP, MMed, PhD, Aurum Health Research Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

August 1, 2005

First Posted (Estimate)

August 2, 2005

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVTN 204
  • 10061 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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