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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
HIV DNA plasmid vaccine plus recombinant fowlpox vector
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Centre in HIV Epidemiology and Clinical Research

Outcomes

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

Full Information

First Posted
January 10, 2003
Last Updated
August 23, 2007
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00051454
Brief Title
Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Cooper, MD, DSc
Organizational Affiliation
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
Official's Role
Study Director
Facility Information:
Facility Name
National Centre in HIV Epidemiology and Clinical Research
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16511428
Citation
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.
Results Reference
result
Links:
URL
http://www.med.unsw.edu.au/nchecr
Description
Related Info

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

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