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

HIV Infections Clinical Trial

— PARC002  

Official title:

A Pilot, Double-blind, Placebo-controlled, Randomized Clinical Trial of mRNA-transfected Autologous Dendritic Cells in Subjects With Well-controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833781
• Other study ID #: 2008p001577
• Secondary ID: R01AI066992-04DA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 29, 2009
• Last updated: March 3, 2016
• Start date: August 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1 Infection
• Infection

Intervention

Biological:
• mRNA-transfected autologous dendritic cells
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
• autologous dendritic cells with no mRNA transfection
Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Locations

Country	Name	City	State
United States	Infectious Disease Unit; Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gandhi RT, Kwon DS, Macklin EA, Shopis JR, McLean AP, McBrine N, Flynn T, Peter L, Sbrolla A, Kaufmann DE, Porichis F, Walker BD, Bhardwaj N, Barouch DH, Kavanagh DG. Immunization of HIV-1-Infected Persons With Autologous Dendritic Cells Transfected With mRNA Encoding HIV-1 Gag and Nef: Results of a Randomized, Placebo-Controlled Clinical Trial. J Acquir Immune Defic Syndr. 2016 Mar 1;71(3):246-53. doi: 10.1097/QAI.0000000000000852. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)	Number of participants with grade 3 or 4 adverse events related to vaccination	After vaccination	No
Primary	Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef	Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline.	Baseline and 14 weeks	No
Secondary	T Cell Proliferation		Baseline to week 14	No
Secondary	IL2 and IFN Gamma Production		Baseline to week 14