- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00695877
Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults
A Phase I Randomized, Double-blind, Placebo Controlled Dose Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenovirus Serotype 5 HVR48 HIV-1 Vaccine (Ad5HVR48.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad5HVR48.ENVA.01 (rAd5HVR48) HIV-1/IPCAVD-002 Vaccine Study)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Control of the HIV pandemic can only be achieved with the development of a safe and effective preventive HIV vaccine. A vaccine that will prevent HIV infection will elicit a strong immune response from both CD4 and CD8 cells. Recombinant adenovirus serotype vectors have been shown to elicit just such a response. The purpose of this study is to determine the safety and immunogenicity of the recombinant adenovirus serotype 5 preventive HIV-1 vaccine.
This study will last 18 to 24 months. Participants will be randomly assigned to one of four arms that will receive vaccine or placebo administered via intramuscular injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Participants in Arm 4 will receive one injection. For most participants, there will be 10 study visits in this study; for participants in Arm 4, there will be only 7 visits. For Arms 1, 2, and 3, study visits will occur at baseline and on Days 0, 14, 28, 42, 56, 168, 182,196, and 365. Participants in Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. For participants in Arm 4, study visits will occur at baseline and on Days 0, 14, 28, 56, 168 and 365. Participants in Arm 4 will receive one injection only, on Day 0. Participants will be asked to record their temperature and other side effects in a symptom log for 3 days after each injection. Risk reduction/pregnancy prevention counseling and physical exams will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. Samples collected will be stored for future testing. HIV testing and pregnancy testing will occur at select visits. At Years 2, 3, 4, and 5, participants will be followed-up by telephone, e-mail, or study visit to collect vital status, and information about any development of significant disability or incapacity, hospitalizations, or congenital anomalies. At these follow-up visits, blood collection will be optional.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS
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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:
- Good general health
- Normal hematological, hepatic and renal functions
- Demonstrated understanding of study
- Willing to receive HIV test results
- HIV-1 and -2 uninfected
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
- Adequate contraception. For more information on this criterion can be found in the protocol.
Exclusion Criteria:
- HIV vaccines or placebos in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
- Blood products within 120 days prior to first injection
- Immunoglobulin within 60 days prior to first injection
- Investigational agents within 30 days prior to first injections
- Live attenuated vaccine within 30 days prior to first injection
- Any vaccine that is not a live attenuated vaccine within 14 days prior to first injection
- Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
- Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
- Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
- Known autoimmune disease
- Known immunodeficiency
- Asthma other than mild, well-controlled asthma
- Diabetes mellitus type 1 or 2
- Thyroidectomy or thyroid disease in the12 months prior to study entry
- Angioedema in the 3 years prior to study entry
- Hypertension. More information on this criterion can be found in the protocol.
- Body mass index (BMI) of 40 or higher OR BMI of 35 or greater, if other cardiovascular risk factors. More information on this criterion can be found in the protocol.
- Bleeding disorder
- Malignancy, unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
- Seizure disorder or occurrence of seizure in the 3 years prior to study entry. Participants who have not required medications or had a seizure for prior 3 years are not excluded.
- Absence of spleen
- Individuals at high-risk of acquiring HIV infection
- Presence of pre-existing neutralizing antibodies for Adenovirus 5 or 48
- Pregnancy or breastfeeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
3 injections of rAd5.ENVA.48
HIV-1 vaccine or placebo at 1 x 10^9 virus particles (VP) given at Days 0, 28, and 168
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Recombinant adenovirus serotype 5 HIV-1 vaccine
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Experimental: 2
3 injections of rAd5.ENVA.48
HIV-1 vaccine or placebo at 1 x 10^10 virus particles (VP) given at Days 0, 28, and 168
|
Recombinant adenovirus serotype 5 HIV-1 vaccine
|
Experimental: 3
3 injections of rAd5.ENVA.48
HIV-1 vaccine or placebo at 1 x 10^11 virus particles (VP) given at Days 0, 28, and 168
|
Recombinant adenovirus serotype 5 HIV-1 vaccine
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Experimental: 4
1 injection of rAd5.ENVA.48
HIV-1 vaccine or placebo at a dose determined by the safety data from Arms 1, 2 and 3 given at Day 0.
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Recombinant adenovirus serotype 5 HIV-1 vaccine
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Local and systemic adverse reactions
Periodo de tiempo: Throughout study
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Throughout study
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Genotipado
Periodo de tiempo: A lo largo del estudio
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A lo largo del estudio
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Humoral Immune response
Periodo de tiempo: Throughout study
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Throughout study
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Cell mediated immunity
Periodo de tiempo: Throughout study
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Throughout study
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Colaboradores e Investigadores
Investigadores
- Silla de estudio: Lindsey Baden, MD, Brigham and Women's Hospital
- Silla de estudio: Dan Barouch, MD, Beth Israel Deaconess Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.
- Stevens W, Kamali A, Karita E, Anzala O, Sanders EJ, Jaoko W, Kaleebu P, Mulenga J, Dally L, Fast P, Gilmour J, Farah B, Birungi J, Hughes P, Manigart O, Stevens G, Yates S, Thomson H, von Lieven A, Krebs M, Price MA, Stoll-Johnson L, Ketter N. Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials. PLoS One. 2008 Apr 30;3(4):e2043. doi: 10.1371/journal.pone.0002043.
- Baden LR, Walsh SR, Seaman MS, Johnson JA, Tucker RP, Kleinjan JA, Gothing JA, Engelson BA, Carey BR, Oza A, Bajimaya S, Peter L, Bleckwehl C, Abbink P, Pau MG, Weijtens M, Kunchai M, Swann EM, Wolff M, Dolin R, Barouch DH. First-in-human evaluation of a hexon chimeric adenovirus vector expressing HIV-1 Env (IPCAVD 002). J Infect Dis. 2014 Oct 1;210(7):1052-61. doi: 10.1093/infdis/jiu217. Epub 2014 Apr 8.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- Ad5HVR48.ENVA.01/IPCAVD-002
- 10701 (Identificador de registro: DAIDS ES Registry Number)
- Ad5HVR48.ENVA.01/ IPCAVD-002
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 Ad5.ENVA.48 HIV-1 vaccine
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