NCT00091416

Brief Summary

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

8 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

September 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

First QC Date

September 8, 2004

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive Vaccine

Interventions

VRC-HIVADV014-00-VPBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Previously enrolled in and have completed all 3 study vaccine injections for HVTN 052
  • Understanding of vaccination procedure
  • Good general health
  • HIV uninfected
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
  • Willing to use acceptable forms of contraception

You may not qualify if:

  • Immunosuppressive medications within 168 days prior to study
  • Blood products within 120 days prior to study
  • Immunoglobulin within 60 days prior to study
  • Live attenuated vaccines within 30 days prior to study
  • Investigational research agents within 30 days prior to study
  • Medically indicated subunit or killed vaccines within 14 days prior to study
  • Allergy shots within 30 days prior to study
  • Current anti-tuberculosis prophylaxis or therapy
  • Anaphylaxis or other serious adverse reactions 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 (e.g., daily symptoms; use of oral or orally inhaled corticosteroids or other treatments; emergent care, urgent care, hospitalization, or intubation during the past 2 years)
  • Diabetes mellitus. A participant with past gestational diabetes is not excluded.
  • Thyroid disease, including removal of thyroid and diagnoses requiring medication. A participant not requiring thyroid medication during the last year is not excluded.
  • Serious angioedema. A participant who has had an episode of angioedema over 3 years prior to the study, and has not required medications for at least 2 years, is not excluded.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore

Baltimore, Maryland, 21205-1901, United States

Location

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts, 02115, United States

Location

Saint Louis Univ. School of Medicine, HVTU

St Louis, Missouri, 63110-2500, United States

Location

HIV Prevention & Treatment CRS

New York, New York, United States

Location

Univ. of Rochester HVTN CRS

Rochester, New York, 14642-0001, United States

Location

Miriam Hospital's HVTU

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, 98104, United States

Location

Related Publications (4)

  • Gomez-Roman VR, Robert-Guroff M. Adenoviruses as vectors for HIV vaccines. AIDS Rev. 2003 Jul-Sep;5(3):178-85.

    PMID: 14598567BACKGROUND

  • McShane H. Prime-boost immunization strategies for infectious diseases. Curr Opin Mol Ther. 2002 Feb;4(1):23-7.

    PMID: 11883691BACKGROUND

  • Pinto AR, Fitzgerald JC, Giles-Davis W, Gao GP, Wilson JM, Ertl HC. Induction of CD8+ T cells to an HIV-1 antigen through a prime boost regimen with heterologous E1-deleted adenoviral vaccine carriers. J Immunol. 2003 Dec 15;171(12):6774-9. doi: 10.4049/jimmunol.171.12.6774.

    PMID: 14662882BACKGROUND

  • 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

Related Links

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

  • Larry Peiperl, MD

    San Francisco Department of Public Health / University of California - San Francisco

    STUDY CHAIR

  • Julie McElrath, MD, PhD

    Fred Hutchinson Cancer Research Center / University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2004

First Posted

September 9, 2004

Study Completion

May 1, 2006

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(8)