Status:
COMPLETED
Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid
Lead Sponsor:
International AIDS Vaccine Initiative
Collaborating Sponsors:
Targeted Genetics Corporation
Conditions:
Human Immunodeficiency Virus Infections
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study volunteers will receive two in...
Detailed Description
The study design will also assess the effect of the presence of anti-AAV2 capsid neutralizing antibodies at the time of vaccination on the safety and immunogenicity of tgAAC09. Since the prevalence of...
Eligibility Criteria
Inclusion
- Healthy male or female
- Age at least 18 years on the day of screening and no greater than 50 years on the day of the first study injection
- Willing to comply with the requirements of the protocol and available for follow up for the planned duration of the study
- Able and willing to give informed consent.
- Willing to undergo HIV testing, counseling and receive results
- If sexually active female of child-bearing potential (not menopausal or anatomically sterile), willing to use an effective method of contraception (hormonal contraceptives; intrauterine contraceptive device (IUCD); condoms; anatomical sterility in self or partner) from screening until at least four months after last study injection and willing to undergo urine pregnancy tests at screening, prior to each injection and four months after the last injection
- If sexually active male, willing to use a method of contraception (such as condoms) from screening until four months after the last study injection
Exclusion
- HIV-1 or HIV-2 infection
- Active tuberculosis
- Clinically relevant abnormality on history or examination including history of immunodeficiency, or cancer, or autoimmune disorder
- Use of systemic corticosteroids, immunosuppressive or anticancer medications in the last six months
- Chronic condition that, in the opinion of the investigator or the designated trial physician, would make the volunteer unsuitable for the study
- Any of the following abnormal laboratory parameters:
- Hemoglobin \<9.0 g/dL (females), \<12.0 g/dL (males)
- Absolute Neutrophil Count (ANC): ≤ 999/mm3
- Absolute Lymphocyte Count (ALC): ≤ 500/mm3
- Platelets: decreased ≤ 90,000 or increased ≥ 550,000/mm3
- Creatinine: \> 1.4 x ULN
- AST: \>3.0 x ULN
- ALT: \>3.0 x ULN
- Urine dipstick: blood = 2+ or more (except in menstruating females); protein = 2+ or more
- Any of the following high-risk behaviors:
- Had unprotected vaginal or anal sex with a known HIV positive person in the past six months
- Had unprotected vaginal or anal sex with a casual partner (i.e. no continuing established relationship) in the past six months
- Engaged in sex work for money or drugs in the past six months
- Used injection drugs illegally in the past six months
- Acquired a sexually transmitted infection (STI) in the past six months
- If female, pregnant, lactating or planning a pregnancy within four months after last study injection
- Receipt of live attenuated vaccine within 30 days or other vaccine within 14 days of the first study injection
- Receipt of blood transfusion or blood products six months prior to the first study injection
- Participation in another clinical trial of an investigational product currently or within last 12 weeks of first study injection or expected participation during this study
- Prior receipt of an investigational HIV vaccine
- History of severe local or systemic reaction to vaccination(s) or history of severe allergic reactions
- History of major neurological or psychiatric disorders
- Positive for hepatitis B surface antigen, active untreated syphilis (confirmed by treponemal test such as TPHA in addition to nontreponemal test such as RPR) or other active sexually transmitted diseases
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00888446
Start Date
October 1 2005
End Date
December 1 2007
Last Update
December 17 2012
Active Locations (5)
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1
Desmond Tutu HIV Centre Cape Town
Cape Town, South Africa, South Africa, 7920
2
Medunsa
South Africa, South Africa, South Africa, 0204
3
Perinatal HIV Research Unit, Baragwanath Hospital
Soweto, South Africa, South Africa, 2013
4
Uganda Virus Research Institute
Entebbe, Entebbe, Uganda