- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00056745
Determining an Effective Site (Groin Versus Arm) for Giving HIV Vaccines
The Role of Immunization Site in Eliciting Mucosal Immunity
Descripción general del estudio
Descripción detallada
The goal of this vaccination study is to evaluate the safety and immunogenicity of the Therion Biologic Corporation (Cambridge, MA) TBC-3B vaccine. TBC-3B consists of live, recombinant vaccinia virus expressing the env and gag/pol genes of HIV-1 strain IIIB. TBC-3B will be administered by subcutaneous injection in the groin and in the deltoid region, with the aim of determining which site is better at inducing mucosal immune responses. Because the groin area drains to the inguinal lymph nodes, vaccines given there may stimulate local immunologic activity in the draining rectal mucosa as well as systemic immunologic activity in the blood.
Volunteers will be followed for 20 months. The first 2 months of the study will be an evaluation of volunteers' normal immune function. Volunteers will then be randomly selected to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid region. Neither volunteers nor study personnel will know which group the volunteer will be in until the day of the first immunization. All volunteers will receive TBC-3B.
During the 20 months of the study, volunteers will be asked to donate blood up to 14 times, undergo seven flexible sigmoidoscopies with biopsies, and receive three pairs of vaccine injections. For up to 36 days after each experimental vaccination, volunteers will be asked to abstain from activity that might spread the virus in the vaccine and put others at risk. Volunteers will receive specific instructions on how to avoid these risks. Volunteers will also be asked not to engage in receptive anal intercourse during the study.
Tipo de estudio
Inscripción
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095-7019
- University of California at Los Angelos Center for HIV and Digestive Diseases
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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
- HIV uninfected
- Low risk for HIV-1 (no sexually transmitted disease within 1 year of study entry, no history of injection drug use, no sex with an HIV infected individual or active injection drug user within 6 months of study entry, no unsafe sexual activity with unknown partners) or mutually monogamous relationship with a known HIV seronegative partner (per subject report) for 6 months prior to study entry
- Born after 1970
- Willingness to abstain from sexual activity for up to 30 days after each vaccination
- Willingness to abstain from receptive anal intercourse during the 20 months of the study
- Available for follow-up during the 20 month duration of the study
- Acceptable methods of contraception
Exclusion Criteria
- Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, radiation, or large doses of corticosteroids
- Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea
- Medical or psychiatric condition or occupational responsibilities which preclude volunteer's compliance with the protocol; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis
- Prior smallpox or vaccinia-based vaccination
- Live attenuated vaccines within 60 days of study. Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 1 month prior to TBC-3B immunizations.
- Anaphylaxis or other serious adverse reactions to vaccines
- Serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension)
- Sexually transmitted disease in the year prior to study entry
- Genital HSV (herpes) or other ulcerative genital lesions
- Active HBV (hepatitis B) or HCV (hepatitis C) infection
- Nonprescribed injection drug use
- Pregnant or lactating women
- Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, eczema)
- Use of experimental agents within 30 days prior to study
- Household contacts with or ongoing occupational exposure to any of the following: pregnant women; children < 12 months of age; people with acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, eczema); people with an immunodeficiency or using immunosuppressive medications
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Safety of administering TBC-3B vaccinations to vaccinia naive individuals
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Medidas de resultado secundarias
Medida de resultado |
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Immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by increased levels of CTL activity directed to vaccinia and HIV-1 env, gag and pol gene products
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immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by anti-HIV-1 directed CD4+ T cell proliferative response to soluble p24 antigen
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immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by CD8+ T cell specificity for HIV-1 epitopes
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immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by serum and mucosal immunoglobulins against HIV-1 epitopes
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Peter Anton, MD, University of California at Los Angeles
Fechas de registro del estudio
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
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- R01AI050467 (Subvención/contrato del NIH de EE. UU.)
- UCLA MIG-001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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Ensayos clínicos sobre TBC-3B
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National Institute of Allergy and Infectious Diseases...Terminado
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National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...TerminadoInfecciones por VIHEstados Unidos, Puerto Rico
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National Institute of Allergy and Infectious Diseases...TerminadoInfecciones por VIHEstados Unidos, Brasil
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Centre Hospitalier Universitaire VaudoisMcGill University; Université du Québec à Trois-Rivières; University of Applied...Desconocido
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International AIDS Vaccine InitiativeTerminado
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National Institute of Allergy and Infectious Diseases...TerminadoSaludableEstados Unidos
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Hadassah Medical OrganizationTerminadoVestibulodinia provocadaIsrael
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Gulf Medical UniversitySrinivas UniversityTerminadoDolor de espalda | Dolor De Espalda Lumbar Crónico | Dolor de espalda con radiación | Dolor de espalda sin radiaciónEmiratos Árabes Unidos
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H. Lee Moffitt Cancer Center and Research InstituteSan Diego State University; University of Minnesota; University of ArizonaTerminadoAnsiedad | Estrés psicológicoEstados Unidos