NCT00125970

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Sep 2005

Typical duration for phase_2 hiv-infections

Geographic Reach
5 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

June 30, 2005

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (5)

  • Local and systemic adverse reactions

    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

    Measured at Day 196

  • Unfractionated IFN-γ ELISpot responses to HIV-1 peptide pools as performed by the FHCRC laboratory

    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

    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

    Measured at Day 210

Secondary Outcomes (5)

  • Humoral immune response to HIV-1 as measured by neutralizing antibody and binding assays

    Measured through Month 36

  • Unfractionated IFN-γ ELISpot responses to HIV-1 as performed by the FHCRC or the VRC laboratories

    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

    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

    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

    Measured through Month 36

Study Arms (2)

1

EXPERIMENTAL

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-VPBiological: VRC-HIVADV014-00-VP

2

PLACEBO COMPARATOR

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 placeboBiological: VRC-HIVADV014-00-VP placebo

Interventions

VRC-HIVDNA016-00-VPBIOLOGICAL

4 mg administered in deltoid

Also known as: Multiclade HIV-1 DNA Plasmid Vaccine
1
VRC-HIVADV014-00-VPBIOLOGICAL

1 x 10\^10 PU administered in deltoid

Also known as: rAD
1
VRC-HIVDNA016-00-VP placeboBIOLOGICAL

1 mL administered at study entry and Months 1 and 2

Also known as: DNA HIV placebo vaccine, Phosphate buffered saline
2
VRC-HIVADV014-00-VP placeboBIOLOGICAL

1 mL administered at Month 6

Also known as: rAD placebo, VRC-DILUENT013-DIL-VP
2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Alabama Vaccine CRS

Birmingham, Alabama, 35294-2041, United States

Location

Project Brave HIV Vaccine CRS

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hosp. CRS

Boston, Massachusetts, 02115, United States

Location

Miriam Hospital's HVTU

Providence, Rhode Island, 02115, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

Projeto Praca Onze/Hesfa Crs

Rio de Janeiro, Brazil

Location

Sao Paulo HVTU - CRT DST/AIDS CRS

São Paulo, Brazil

Location

Les Centres GHESKIO CRS

Port-au-Prince, Haiti

Location

Epidemiology Research & Training Unit Jamaica MOH CRS

Kingston, Jamaica

Location

Soweto HVTN CRS

Johannesburg, Gauteng, South Africa

Location

Emavundleni Desmond Tutu HIV Centre CRS

Cape Town, South Africa

Location

CAPRISA Aurum CRS

Klerksdorp, South Africa

Location

Related Publications (7)

  • Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.

    PMID: 12699356BACKGROUND

  • Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.

    PMID: 12089434BACKGROUND

  • Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. doi: 10.1128/JVI.75.13.5721-5729.2001. No abstract available.

    PMID: 11390574BACKGROUND

  • Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.

    PMID: 14738219BACKGROUND

  • Fischinger S, Cizmeci D, Deng D, Grant SP, Frahm N, McElrath J, Fuchs J, Bart PA, Pantaleo G, Keefer M, O Hahn W, Rouphael N, Churchyard G, Moodie Z, Donastorg Y, Streeck H, Alter G. Sequence and vector shapes vaccine induced antibody effector functions in HIV vaccine trials. PLoS Pathog. 2021 Nov 29;17(11):e1010016. doi: 10.1371/journal.ppat.1010016. eCollection 2021 Nov.

    PMID: 34843602DERIVED

  • Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.

    PMID: 25820067DERIVED

  • Churchyard GJ, Morgan C, Adams E, Hural J, Graham BS, Moodie Z, Grove D, Gray G, Bekker LG, McElrath MJ, Tomaras GD, Goepfert P, Kalams S, Baden LR, Lally M, Dolin R, Blattner W, Kalichman A, Figueroa JP, Pape J, Schechter M, Defawe O, De Rosa SC, Montefiori DC, Nabel GJ, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204). PLoS One. 2011;6(8):e21225. doi: 10.1371/journal.pone.0021225. Epub 2011 Aug 3.

    PMID: 21857901DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Michael Keefer, MD

    University of Rochester

    STUDY CHAIR

  • Gavin Churchyard, MBBCh, FCP, MMed, PhD

    Aurum Health Research Limited

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

August 2, 2005

Study Start

September 1, 2005

Primary Completion

February 1, 2008

Study Completion

January 1, 2010

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations

JA(1)HA(1)US(5)BR(2)ZA(3)