Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers

GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Dose Escalation Study of GENEVAX-HIV Delivered Intramuscularly Using the Biojector 2000 in HIV Seronegative Volunteers

Patrocinadores

Patrocinador principal: Wyeth-Lederle Vaccines

Fuente NIH AIDS Clinical Trials Information Service
Resumen breve

The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.

Descripción detallada

In this open-label study, volunteers are given an intramuscular injection of GENEVAX-HIV vaccine using the Biojector 2000. Safety measures and immune response are assessed accordingly.

Estado general Completed
Fase Phase 1
Tipo de estudio Interventional
Condición
Intervención

Tipo de intervención: Biological

Nombre de intervención: APL 400-003

Elegibilidad

Criterios:

Inclusion Criteria

You may be eligible for this study if you:

- Are 18 - 60 years old.

- Are HIV-negative and in good health.

- Are able to understand how infections such as HIV are spread.

- Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

- Have hepatitis B or C.

- Have any condition that may prevent you from completing the study.

- Are allergic to bupivacaine, vaccines, or certain local anesthetics.

- Have taken certain medications or have received certain therapies that may affect your immune system.

- Have an immune system disorder or have received therapy for an immune system disorder.

- Have been exposed to HIV within 6 months prior to study entry.

- Have received an experimental HIV vaccine or any other experimental treatment within 30 days prior to study entry.

- Have received blood transfusions within 6 months prior to study entry.

- Abuse alcohol or drugs or have an uncontrolled psychiatric disorder.

- Are pregnant or breast-feeding.

Género: All

Edad mínima: 18 Years

Edad máxima: 60 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel
RR MacGregor Study Chair
Ubicación
Instalaciones: Univ of Pennsylvania Med Ctr
Ubicacion Paises

United States

Fecha de verificación

May 2000

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Propósito primario: Prevention

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov