NCT00384787

Brief Summary

The purpose of this study is to determine the safety of, immune response to, and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine. The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers (intradermally), or under the skin (subcutaneously). NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1 hiv-infections

Geographic Reach
2 countries

7 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

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

October 4, 2006

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityAdenoviral Vector VaccineDNA Plasmid VaccineHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (2)

  • Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)

    After each injection and for 12 months after the first injection

  • Magnitude of HIV-specific T-cell responses assessed by the magnitude of IFN-gamma enzyme-linked immunosorbent spot (ELISpot) responses

    4 weeks after adenoviral vaccine boost

Secondary Outcomes (1)

  • Titer of HIV-specific binding antibodies assessed by enzyme-linked immunosorbent assay (ELISA)

    4 weeks after adenoviral vaccine boost

Study Arms (3)

1

EXPERIMENTAL

Group 1 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost intramuscularly at Month 6.

Biological: VRC-HIVDNA009-00-VPBiological: VRC-HIVADV014-00-VP

2

EXPERIMENTAL

Group 2 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost intradermally at Month 6.

Biological: VRC-HIVDNA009-00-VPBiological: VRC-HIVADV014-00-VP

3

EXPERIMENTAL

Group 3 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost subcutaneously at Month 6.

Biological: VRC-HIVDNA009-00-VPBiological: VRC-HIVADV014-00-VP

Interventions

VRC-HIVDNA009-00-VPBIOLOGICAL

HIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2

123
VRC-HIVADV014-00-VPBIOLOGICAL

Adenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6

123

Eligibility Criteria

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

You may qualify if:

  • HIV-1 and -2 uninfected
  • Good general health
  • Pre-existing adenovirus 5 (Ad5) neutralizing antibody titers of a 1:12 ratio or greater
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
  • Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
  • Willing to receive HIV test results
  • Able to understand the vaccination procedure
  • Willing to use acceptable forms of contraception

You may not qualify if:

  • HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
  • Immunosuppressive medications within 168 days prior to first study vaccination
  • Blood products within 120 days prior to first study vaccination
  • Immunoglobulin within 60 days prior to first study vaccination
  • Live attenuated vaccines within 30 days prior to first study vaccination
  • Investigational research agents within 30 days prior to first study vaccination
  • Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
  • Allergy treatment with antigen injections within 30 days prior to first study vaccination
  • Current anti-tuberculosis (TB) preventive therapy or treatment
  • Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
  • 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 reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection. Participants who have been fully treated for syphilis more than 6 months prior to study entry are not excluded.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Alabama Vaccine CRS

Birmingham, Alabama, 35294, United States

Location

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, 02115-6110, United States

Location

NY Blood Ctr./Union Square CRS

New York, New York, 10003, United States

Location

Columbia P&S CRS

New York, New York, 10032-3732, United States

Location

NY Blood Ctr./Bronx CRS

The Bronx, New York, 10455, United States

Location

Seattle Vaccine and Prevention CRS

Seattle, Washington, 98109-1024, United States

Location

ACSA CRS

Iquitos, Maynas, 1, Peru

Location

Related Publications (6)

  • Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149.

    PMID: 15761255BACKGROUND

  • Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004 Nov 25;351(22):2295-301. doi: 10.1056/NEJMoa043540. Epub 2004 Nov 3.

    PMID: 15525714BACKGROUND

  • Pittman PR, Kim-Ahn G, Pifat DY, Coonan K, Gibbs P, Little S, Pace-Templeton JG, Myers R, Parker GW, Friedlander AM. Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans. Vaccine. 2002 Jan 31;20(9-10):1412-20. doi: 10.1016/s0264-410x(01)00462-5.

    PMID: 11818160BACKGROUND

  • Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. doi: 10.1146/annurev.med.55.091902.104344.

    PMID: 14746526BACKGROUND

  • 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

  • Koblin BA, Casapia M, Morgan C, Qin L, Wang ZM, Defawe OD, Baden L, Goepfert P, Tomaras GD, Montefiori DC, McElrath MJ, Saavedra L, Lau CY, Graham BS; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of an HIV adenoviral vector boost after DNA plasmid vaccine prime by route of administration: a randomized clinical trial. PLoS One. 2011;6(9):e24517. doi: 10.1371/journal.pone.0024517. Epub 2011 Sep 12.

    PMID: 21931737DERIVED

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

  • Beryl Koblin, PhD

    New York Blood Center

    STUDY CHAIR

  • Martin Casapia, MD

    Asociación Civil Impacta Salud y Educación (IMPACTA), Peru

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2008

Study Completion

December 1, 2012

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

PE(1)US(6)