NCT00119873

Brief Summary

The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine in HIV uninfected individuals.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

3 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

July 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

First QC Date

July 12, 2005

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV Preventive VaccineAIDS VaccinesAdenoviridae

Outcome Measures

Primary Outcomes (2)

  • Blood and chemical parameters for 12 months after injection

  • Local and systemic adverse reactions for 12 months after injection

Interventions

VRC-HIVADV014-00-VPBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Have access to a participating site and are willing to be followed for the duration of the study
  • Willing to receive HIV test results
  • Able to understand and comply with study requirements
  • In good general health
  • Have neutralizing adenovirus antibody levels that are less than a 1:12 ratio
  • Agree to use acceptable methods of contraception for at least 21 days prior to study start and for the duration of the study.

You may not qualify if:

  • HIV infected
  • Positive hepatitis B surface antigen
  • Positive anti-hepatitis C virus antibodies
  • Prior receipt of an HIV vaccine
  • Immunosuppressive drugs within 168 days prior to first vaccination
  • Have received donated blood within 120 days prior to first vaccination
  • Have received immunoglobulin within 60 days of the first vaccination
  • Live attenuated vaccines or investigational research agents within 30 days prior to first vaccination
  • Subunit or killed vaccines within 14 days prior to first vaccination
  • Current preventive or therapeutic anti-tuberculosis (TB) treatment
  • Any medical, psychiatric, or social condition that would interfere with the study
  • Any occupational or other responsibility that would interfere with the study
  • Serious adverse reactions to vaccines
  • Autoimmune disease
  • Immunodeficiency
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

San Francisco Vaccine and Prevention CRS

San Francisco, California, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, 98104, United States

Location

Related Publications (5)

  • Shiver J. A non-replicating adenoviral vector as a potential HIV vaccine. Res Initiat Treat Action. 2003 Spring;8(2):14-6.

    PMID: 12845771BACKGROUND

  • Casimiro DR, Bett AJ, Fu TM, Davies ME, Tang A, Wilson KA, Chen M, Long R, McKelvey T, Chastain M, Gurunathan S, Tartaglia J, Emini EA, Shiver J. Heterologous human immunodeficiency virus type 1 priming-boosting immunization strategies involving replication-defective adenovirus and poxvirus vaccine vectors. J Virol. 2004 Oct;78(20):11434-8. doi: 10.1128/JVI.78.20.11434-11438.2004.

    PMID: 15452269BACKGROUND

  • 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

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

    PMID: 14598567BACKGROUND

  • Peiperl L, Morgan C, Moodie Z, Li H, Russell N, Graham BS, Tomaras GD, De Rosa SC, McElrath MJ; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of a replication-defective adenovirus type 5 HIV vaccine in Ad5-seronegative persons: a randomized clinical trial (HVTN 054). PLoS One. 2010 Oct 27;5(10):e13579. doi: 10.1371/journal.pone.0013579.

    PMID: 21048953RESULT

MeSH Terms

Conditions

HIV InfectionsAdenoviridae Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Laurence Peiperl, MD

    San Francisco Department of Public Health

    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

July 12, 2005

First Posted

July 14, 2005

Study Completion

October 1, 2006

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(3)