- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Cape Town, Sudáfrica, 7920
- Desmond Tutu HIV Centre Cape Town
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South Africa, Sudáfrica, 0204
- Medunsa
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Soweto, Sudáfrica, 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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Comparador de placebos: Placebo
3 volunteers will receive placebo matched to each experimental group.
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Sterile isotonic buffered salt solution
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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
Periodo de tiempo: 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
Periodo de tiempo: 18 months
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18 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Safety: high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 18 months
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18 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Eftyhia Vardas, MD, Perinatal HIV Research Unit (PHRU), Baragwanath
- Investigador principal: Linda-Gail Bekker, MD, Desmond Tutu HIV Centre Cape Town
- Investigador principal: Anwar Hoosen, Medical University of Southern Africa (Medunsa)
- Investigador principal: Elwyn Chomba, MD, Zambia-Emory HIV Research Project (ZEHRP), Lusaka
- Investigador principal: Pontiano Kaleebu, MD, PhD, MRC/UVRI and LSHTM Uganda Research Unit
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones transmitidas por la sangre
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Atributos de la enfermedad
- Enfermedades de virus lentos
- Infecciones por VIH
- Infecciones
- Enfermedades contagiosas
- Síndrome de inmunodeficiencia adquirida
Otros números de identificación del estudio
- IAVI A002
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Ensayos clínicos sobre Infecciones por VIH
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Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
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Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
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China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán
Ensayos clínicos sobre tgAAC09
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International AIDS Vaccine InitiativeChildren's Hospital of Philadelphia; Nationwide Children's Hospital; Targeted Genetics...TerminadoInfección por VIHBélgica, Alemania, India