Thai Prophylactic HIV Vaccine Phase I Study

HIV Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00333424
• Other study ID #: NCHECR-AE1
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 1, 2006
• Last updated: June 11, 2012
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2012
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Thai Food and Drug Administration, the Subcommittee on HIV/AIDS Vaccine Development (SHAVD)Thailand: Chulalongkorn University Ethics Committee for Human ResearchThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00476749
• NCT00859820
• NCT00859248

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
Thailand	HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Kirby Institute	Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Hemachandra A, Puls RL, Sirivichayakul S, Kerr S, Thantiworasit P, Ubolyam S, Cooper DA, Emery S, Phanuphak P, Kelleher A, Ruxrungtham K. An HIV-1 clade A/E DNA prime, recombinant fowlpox virus boost vaccine is safe, but non-immunogenic in a randomized ph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		13 weeks	Yes
Secondary	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.		week 13	No

External Links

•   National Centre in HIV Epidemiology and Clinical Research Homepage