NCT00051454

Brief Summary

This study will examine the safety and immune response to a two-part HIV vaccine. Healthy volunteers who are at low risk of HIV infection will receive either active vaccine or a placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

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

January 10, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

August 27, 2007

Status Verified

August 1, 2007

First QC Date

January 10, 2003

Last Update Submit

August 23, 2007

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (3)

  • Safety and adverse events among the two vaccination groups

  • lymphoproliferative (LP) responses to HIV antigens, as assessed by LP assays at Week 9

  • CD8+ T cell responses to HIV antigens, as assessed by ELIspot assay of interferon gamma (IFN-g) secreting cells at Week 9

Secondary Outcomes (6)

  • Proportion of patients with positive LP assay and ELISPOT assay responses

  • intracellular cytokine staining (ICS) of IFN-g/CD69 and flow cytometry

  • 51-Cr release cytotoxic T cell lymphocyte assay

  • HLA class I tetramer analyses

  • anti-HIV gag, pol and env antibodies, as assessed by ELISA and Western blot

  • +1 more secondary outcomes

Interventions

HIV DNA plasmid vaccine plus recombinant fowlpox vectorBIOLOGICAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV negative.
  • Acceptable methods of contraception.

You may not qualify if:

  • Identifiable risk behavior for HIV infection, including: sexual partners of HIV positive people, sexual intercourse with a partner of unknown HIV status if that partner is reported to be at higher risk for HIV infection, gay men reporting any unprotected anal intercourse with partners of unknown status in the 12 months preceding study entry, individuals diagnosed with a sexually transmissible infection (STI) in the 12 months preceding entry that may have been acquired through anal or vaginal intercourse, individuals reporting sharing of injecting equipment in the last 12 months.
  • HIV candidate vaccines in a previous HIV vaccine trial.
  • Hypersensitivity to egg products or a known history of anaphylaxis or any other serious adverse reactions to vaccination.
  • History of serious allergic reaction requiring hospitalization or emergency medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) to any substance.
  • Significant illness requiring immunomodulatory or cytotoxic therapy.
  • History of cancer unless there is evidence of surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
  • Blood products or immunoglobulins within 6 months prior to entering the study.
  • Experimental or investigational agents within 30 days prior to entering the study.
  • Recreational and/or therapeutic drug use that might compromise the study participant's safety.
  • Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Centre in HIV Epidemiology and Clinical Research

Sydney, New South Wales, 2010, Australia

Location

Related Publications (1)

  • Kelleher AD, Puls RL, Bebbington M, Boyle D, Ffrench R, Kent SJ, Kippax S, Purcell DF, Thomson S, Wand H, Cooper DA, Emery S. A randomized, placebo-controlled phase I trial of DNA prime, recombinant fowlpox virus boost prophylactic vaccine for HIV-1. AIDS. 2006 Jan 9;20(2):294-7. doi: 10.1097/01.aids.0000199819.40079.e9.

    PMID: 16511428RESULT

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

  • David A Cooper, MD, DSc

    National Centre in HIV Epidemiology and Clinical Research, University of New South Wales

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 10, 2003

First Posted

January 13, 2003

Study Start

March 1, 2003

Study Completion

February 1, 2005

Last Updated

August 27, 2007

Record last verified: 2007-08

Locations

AU(1)