Thai Prophylactic HIV Vaccine Phase I Study
June 11, 2012 updated by: Kirby Institute
A Randomised, Placebo-Controlled, Double-Blind, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic pHIS-HIV-AE DNA Prime and rFPV-HIV-AE Boost HIV Vaccination Strategy
The development of a safe and effective vaccine for HIV is the subject of intensive world-wide research.
Various approaches are being investigated in monkey models and humans.
This is a randomized, double-blind trial to evaluate the safety and immunogenicity of a candidate preventative human immunodeficiency virus (HIV) vaccine strategy in 24 healthy adult Thai volunteers with no identifiable risk behaviour for HIV-1 infection.
Volunteers will receive three "priming" vaccinations at weeks 0, 4 and 8 (pHIS-HIV-AE, a DNA vector delivering AE clade HIV-1 genes).
This will be followed at week 12 by single "boost" vaccination (rFPV-HIV-AE, non-replicating, recombinant fowlpox virus vector delivering the same HIV-1 genes).
Safety and immunological monitoring will continue to 52 weeks
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand, 10330
- HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers, as judged by the screening physician based on medical history, physical examination and laboratory results
- 18 - 55 years of age, inclusive
- Laboratory blood values within clinically acceptable range
- Women of reproductive potential must have a negative urine beta-human chorionic gonadotropin (B-HCG) pregnancy test at both the screening and baseline visits
- Agreement to employ barrier contraception for 4 weeks preceding entry and for the whole duration of the study (52 weeks)
- Agreement to undertake HIV testing and to receive results
- Provision of written informed consent approved by the Institutional Ethics Committee (IEC).
Exclusion Criteria:
- HIV positive
- HBsAg or HCV positive
Identifiable risk behaviour for HIV infection, defined as any one of the following:
- sexual partners of HIV positive people
- individuals reporting unprotected intercourse with a partner of unknown HIV status, if that partner is reported to be at higher risk for HIV infection ("higher risk of HIV infection" is defined as individuals reporting unprotected anal intercourse (UAI), unprotected intercourse with sex workers and/or sharing injecting equipment within the 12 months preceding trial entry
- men reporting any UAI with male partners of unknown status in the 12 months preceding entry to the study
- individuals who in the 12 months preceding entry to the study have been diagnosed with a new sexually transmissible infection (STI) that may have been acquired through anal or vaginal intercourse (receptive or insertive)
- individuals reporting sharing of injecting equipment in the last 12 months
- Recipients of prior HIV candidate vaccines in a previous HIV vaccine trial (does not apply to volunteers who received placebo or adjuvant in such a trial)
- Recipients of live attenuated vaccines within 60 days prior to entering the study. Whole killed, toxoid or sub-unit vaccines e.g. influenza, pneumococcus, tetanus, hepatitis B are not exclusionary when given at least 4 weeks prior to the scheduled experimental HIV vaccines
- Known or suspected hypersensitivity to egg products or a known history of anaphylaxis or any other serious adverse reactions to any vaccinations
- History of serious allergic reactions requiring hospitalisation or emergency medical care (e.g. Steven-Johnson's syndrome, bronchospasm or hypotension) to any substance
- Clinically significant intercurrent illness or a history of clinically significant illness requiring immunomodulatory (including corticosteroids) or cytotoxic treatment (e.g. cancer) or any significant disease conditions that in the opinion of the Principal Investigator precludes the individual from participating in the study
- Recipients of blood products or immunoglobulins within 6 months prior to entering the study
- Recipients of experimental or investigational agents within 30 days prior to entering the study
- Recreational and/or therapeutic drug-use that, in the opinion of the Principal Investigator, might compromise the volunteer's participation in any way
- Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
- Pregnant or lactating women, or women planning to become pregnant during the trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
placebo containing diluent alone
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6mg pHIS-HIV-AE at weeks 0, 4 and 8; 3 x 10e8 pfu/mL rFPV-HIV-AE at week 12
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
All safety data summarised & compared by randomly assigned vaccination group. Primary immunological outcome is mean difference in change in percent of IFN-y + CD4+ and/or CD8+ cells by intracellular cytokine staining (ICCS) from week 0 to 13.
Time Frame: 13 weeks
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13 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of patients with positive ICCS assay responses; peripheral blood mononuclear cell responses to HIV antigens; proportion of patients with positive ELIspot assay responses; anti-HIV Gag, Pol & Env antibodies.
Time Frame: week 13
|
week 13
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kiat Ruxrungtham, MD PhD, HIV-NAT, Thai Red Cross AIDS Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
June 1, 2006
First Submitted That Met QC Criteria
June 1, 2006
First Posted (Estimate)
June 5, 2006
Study Record Updates
Last Update Posted (Estimate)
June 13, 2012
Last Update Submitted That Met QC Criteria
June 11, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCHECR-AE1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.