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Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00051454
Recruitment Status : Completed
First Posted : January 13, 2003
Last Update Posted : August 27, 2007
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE January 10, 2003
First Posted Date  ICMJE January 13, 2003
Last Update Posted Date August 27, 2007
Study Start Date  ICMJE March 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
  • 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
  • behavioral changes in study participants
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
Official Title  ICMJE A Randomised, Placebo-Controlled, Double-Blind, Phase I/IIa Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic DNA Prime-rFPV Boost HIV Vaccination Strategy
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.
Detailed Description

The purpose of this study is to examine the safety and immunogenicity of a candidate vaccine strategy for HIV prophylaxis using a DNA-prime plus recombinant fowlpox boost. The DNA plasmid and fowlpox vector contain HIV genes. However, these vaccines contain only some HIV genes and cannot themselves cause HIV or AIDS.

Eligible volunteers at low risk of HIV infection will be randomized to receive either active vaccine or placebo injections at Day 0, Week 4, and Week 8. Intensive immunologic and safety monitoring will be done during the first 16 weeks of the study. Follow-up will continue to Week 52.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE Biological: HIV DNA plasmid vaccine plus recombinant fowlpox vector
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

  • HIV negative.
  • Acceptable methods of contraception.

Exclusion Criteria

  • 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.
  • Live attenuated vaccines within 60 days prior to entering the study. Whole killed, toxoid, or sub-unit vaccines (e.g., influenza, pneumococcal, tetanus, and hepatitis B) are not exclusionary within 4 weeks prior to the scheduled experimental HIV vaccines.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00051454
Other Study ID Numbers  ICMJE N01-AI05395
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David A Cooper, MD, DSc National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP