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HIV-1-Gag Conserved-Element DNA Vaccine as Therapeutic Vaccination in HIV-Infected Persons With Viral Suppression on Antiretroviral Therapy

2018-06-25 04:40:13 | BioPortfolio

Summary

This study will evaluate the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons who are on antiretroviral therapy (ART). The study aims to induce potent virus-specific cytotoxic T lymphocytes (CTL) responses.

Description

This study will evaluate the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons who are on antiretroviral therapy (ART).

The study will randomly assign participants to one of three groups. Participants in Arm 1 will receive p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55^gag pDNA vaccine at Weeks 12 and 24. Participants in Arm 2 will receive full-length p55^gag pDNA vaccine at Weeks 0, 4, 12, and 24. Participants in Arm 3 will receive placebo at Weeks 0, 4, 12, and 24.

Study visits will occur at Weeks 0, 4, 6, 12, 24, 26, and 48 and may include physical examinations and blood and urine collection. Some participants may undergo leukapheresis and stool sample collection.

Study Design

Conditions

HIV Infections

Intervention

p24CE1/2 pDNA vaccine, p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine, Full-length p55^gag pDNA vaccine, Placebo

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-06-25T04:40:13-0400

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Medical and Biotech [MESH] Definitions

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

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A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed)

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