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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00051454
First received: January 10, 2003
Last updated: August 23, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: HIV DNA plasmid vaccine plus recombinant fowlpox vector
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 24
Study Start Date: March 2003
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051454

Locations
Australia, New South Wales
National Centre in HIV Epidemiology and Clinical Research
Sydney, New South Wales, Australia, 2010
Sponsors and Collaborators
Investigators
Study Director: David A Cooper, MD, DSc National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00051454     History of Changes
Other Study ID Numbers: N01-AI05395
Study First Received: January 10, 2003
Last Updated: August 23, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014