Thai Prophylactic HIV Vaccine Phase I Study

This study has been terminated.
(Vaccines safe but not immunogenic in 8 participants; trial closed to further recruitment by the protocol steering committee & DSMB.)
Sponsor:
Collaborator:
Thai Red Cross AIDS Research Centre
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00333424
First received: June 1, 2006
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
HIV
Biological: pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: August 2007
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo containing diluent alone
Biological: pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine
6mg pHIS-HIV-AE at weeks 0, 4 and 8; 3 x 10e8 pfu/mL rFPV-HIV-AE at week 12

  Eligibility

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

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.
  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: NCT00333424

Locations
Thailand
HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Sponsors and Collaborators
Kirby Institute
Thai Red Cross AIDS Research Centre
Investigators
Principal Investigator: Kiat Ruxrungtham, MD PhD HIV-NAT, Thai Red Cross AIDS Research Center
  More Information

Additional Information:
Publications:
Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT00333424     History of Changes
Obsolete Identifiers: NCT00476749, NCT00859820, NCT00859248
Other Study ID Numbers: NCHECR-AE1
Study First Received: June 1, 2006
Last Updated: June 11, 2012
Health Authority: Thailand: Thai Food and Drug Administration, the Subcommittee on HIV/AIDS Vaccine Development (SHAVD)
Thailand: Chulalongkorn University Ethics Committee for Human Research
Thailand: Ministry of Public Health

Keywords provided by Kirby Institute:
HIV
Human Immunodeficiency Virus
Prophylactic vaccine

ClinicalTrials.gov processed this record on August 20, 2014