A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects (PARC002)

Mass General Brigham

Status and phase: Completed; Phase 2; Phase 1

Conditions: HIV-1 Infection; HIV Infections

Treatments: Biological: mRNA-transfected autologous dendritic cells; Biological: autologous dendritic cells with no mRNA transfection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00833781

DAIDS-ES ID 10731 (Other Identifier)

2008p001577

R01AI066992-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.

Full description

This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-1 positive
• CD4+ T Cell count >200
• Undetectable HIV viral load for 6 months prior to screening
• On antiretroviral treatment for 12 months prior to screening

Exclusion criteria

• Hepatitis C positive
• Detectable HIV viral load within 6 months prior to study entry
• Females who are pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

15 participants in 2 patient groups, including a placebo group

mRNA-transfected dendritic cells

Active Comparator group

Description:

Participants in this arm/group received mRNA-transfected autologous dendritic cells

Treatment:

Biological: mRNA-transfected autologous dendritic cells

Dendritic cells without mRNA

Placebo Comparator group

Description:

Participants in this arm/group received autologous dendritic cells with no mRNA transfection

Treatment:

Biological: autologous dendritic cells with no mRNA transfection