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A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

rgp120/HIV-1 SF-2

+ Env 2-3
+ HIVAC-1e
Biológico
Quiénes están siendo reclutados

HIV Infections

De 18 a 60 años
Cómo está diseñado el estudio

Estudio de Prevención

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters. Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone. In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone. In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone. Seventy healthy volunteers are randomized to one of four groups. Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3, respectively, at months 8 and 12. Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12. Group C receives three doses of subunit gp120 only at months 0, 8 and 12. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) have been eliminated.) Subjects are followed for 18 months.

Título OficialA Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 56 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Prevención
Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
De 18 a 60 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Criterios

Inclusion Criteria Subjects must have: * Normal history and physical exam. * Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen). * History of smallpox vaccination more than 5 years prior to enrollment. * Normal urinalysis. * Absolute CD4 count = or \> 500 cells/mm3. Prior Medication: Required: * Vaccinia (smallpox) vaccination more than 5 years prior to study enrollment. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire/interview. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: * Household contacts who are pregnant, \< 12 months of age, have eczema, or have immunodeficiency disease or who use immunosuppressive medications. * Hepatitis B surface antigenemia. * Medical or psychiatric condition or occupational responsibilities that preclude compliance. Subjects with the following prior conditions are excluded: * History of immunodeficiency or chronic illness. * Eczema within the past year. Prior Medication: Excluded: * Prior experimental HIV vaccine. * Immunoglobulin administration or use of experimental agent within the past 2 months. * History of immunosuppressive medications. Prior Treatment: Excluded: * Blood or blood product transfusion within the previous 6 months.



Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.
Este estudio tiene una ubicación
Suspendido
JHU AVEGPittsburgh, United StatesVer ubicación

Completado1 Centros de Estudio