- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00888446
Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid (TGC14F)
Phase II, Placebo-controlled, Double-blind, Dose-escalation/Dose-optimization Trial to Evaluate Safety and Immunogenicity of tgAAC09, an HIV Vaccine Containing Clade C Gag-PR-ΔRT DNA in an Adeno-associated Virus (AAV) Capsid
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Cape Town, South Africa, 7920
- Desmond Tutu HIV Centre Cape Town
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South Africa, South Africa, 0204
- Medunsa
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Soweto, South Africa, 2013
- Perinatal HIV Research Unit, Baragwanath Hospital
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Entebbe, Uganda
- Uganda Virus Research Institute
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Lusaka, Zambia
- Zambia-Emory HIV Research Project (ZEHRP)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group A
Number of Vaccine Recipients: 10 Dosage level 3 x 10^10 DRP Month 0 + 6 |
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Experimental: Group B
Number of Vaccine Recipients: 10 Dosage level 3 x 10^10 DRP Month 0+12 |
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Experimental: Group C
Number of Vaccine Recipients: 10 Dosage level 3 x 10^11 DRP Month 0+6 |
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Experimental: Group D
Number of Vaccine Recipients: 10 Dosage level 3 x 10^11 DRP Month 0+12 |
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Experimental: Group E
Number of Vaccine Recipients: 10 Dosage level 3 x 10^12 DRP Month 0+6 |
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Experimental: Group F
Number of Vaccine Recipients: 10 Dosage level 3 x 10^12 DRP Month 0+12 |
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Experimental: Group G
Number of Vaccine Recipients: 10 Preselected for baseline AAV neutralization titers of <1/8 Dosage level 3 x 10^12 DRP Month 0+6 |
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Placebo Comparator: Placebo
3 volunteers will receive placebo matched to each experimental group.
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Sterile isotonic buffered salt solution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety: proportion of volunteers with severe local and systemic reactions, proportion of volunteers with other SAEs (including laboratory abnormalities) related to study vaccine, number of volunteers with SAEs related to study vaccine
Time Frame: 18 months
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18 months
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Proportion of volunteers with HIV-1 specific T- cell responses quantified by γ-IFN ELISPOT and magnitude of the response, and proportion of volunteers with HIV-1 specific binding antibodies and magnitude of the response
Time Frame: 18 months
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18 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination
Time Frame: 18 months
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18 months
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Immunogenicity: proportion of volunteers with HIV-1 specific T- cell responses by γ-IFN CFC or other T-cell assays
Time Frame: 18 months
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18 months
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Immunogenicity endpoints in volunteers with high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination
Time Frame: 18 months
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18 months
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Immunogenicity endpoints in volunteers with versus without four-fold or greater increase in titres of neutralizing antibodies to AAV2 after vaccination
Time Frame: 18 months
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18 months
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Immunogenicity endpoints after the second study injection, compared with the first study injection
Time Frame: 18 months
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18 months
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Immunogenicity endpoints after the second study injection following a twelve-month interval compared to a six-month interval
Time Frame: 18 months
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18 months
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Vaccine biodistribution: presence and persistence of vaccine in peripheral blood mononuclear cells (PBMC), saliva, nasal swabs, urine and semen or cervical/vaginal secretions
Time Frame: 18 months
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18 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Eftyhia Vardas, MD, Perinatal HIV Research Unit (PHRU), Baragwanath
- Principal Investigator: Linda-Gail Bekker, MD, Desmond Tutu HIV Centre Cape Town
- Principal Investigator: Anwar Hoosen, Medical University of Southern Africa (Medunsa)
- Principal Investigator: Elwyn Chomba, MD, Zambia-Emory HIV Research Project (ZEHRP), Lusaka
- Principal Investigator: Pontiano Kaleebu, MD, PhD, MRC/UVRI and LSHTM Uganda Research Unit
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- IAVI A002
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.
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