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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051454
• Other study ID #: N01AI05395
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 10, 2003
• Last updated: August 23, 2007
• Start date: March 2003
• Est. completion date: February 2005

Study information

• Verified date: August 2007
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• HIV DNA plasmid vaccine plus recombinant fowlpox vector

Locations

Country	Name	City	State
Australia	National Centre in HIV Epidemiology and Clinical Research	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Australia, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and adverse events among the two vaccination groups
Primary	lymphoproliferative (LP) responses to HIV antigens, as assessed by LP assays at Week 9
Primary	CD8+ T cell responses to HIV antigens, as assessed by ELIspot assay of interferon gamma (IFN-g) secreting cells at Week 9
Secondary	Proportion of patients with positive LP assay and ELISPOT assay responses
Secondary	intracellular cytokine staining (ICS) of IFN-g/CD69 and flow cytometry
Secondary	51-Cr release cytotoxic T cell lymphocyte assay
Secondary	HLA class I tetramer analyses
Secondary	anti-HIV gag, pol and env antibodies, as assessed by ELISA and Western blot
Secondary	behavioral changes in study participants

External Links

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