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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Rajesh T. Gandhi, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00833781

First received: January 29, 2009

Last updated: March 3, 2016

Last verified: March 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
HIV-1 Infection HIV Infections	Biological: mRNA-transfected autologous dendritic cells Biological: autologous dendritic cells with no mRNA transfection	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Rajesh T. Gandhi, MD, Massachusetts General Hospital:

Primary Outcome Measures:

Safety of the DC Vaccine (as Measured by Frequency of Adverse Events) [ Time Frame: After vaccination ]
Number of participants with grade 3 or 4 adverse events related to vaccination
Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef [ Time Frame: Baseline and 14 weeks ]
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.

Secondary Outcome Measures:

T Cell Proliferation [ Time Frame: Baseline to week 14 ]
IL2 and IFN Gamma Production [ Time Frame: Baseline to week 14 ]


Enrollment:	15
Study Start Date:	August 2009
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: mRNA-transfected dendritic cells Participants in this arm/group received mRNA-transfected autologous dendritic cells	Biological: mRNA-transfected autologous dendritic cells Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Placebo Comparator: Dendritic cells without mRNA Participants in this arm/group received autologous dendritic cells with no mRNA transfection	Biological: autologous dendritic cells with no mRNA transfection Injections will be administered intradermally at weeks 0, 2, 6 and 10. Other Name: Autologous dendritic cells not transfected with mRNA.

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833781

Locations


United States, Massachusetts
Infectious Disease Unit; Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Principal Investigator:	Rajesh Gandhi, MD	Massachusetts General Hospital

More Information

Publications:

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.


Responsible Party:	Rajesh T. Gandhi, MD, Director of Education, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00833781 History of Changes
Other Study ID Numbers:	2008p001577 R01AI066992-04 ( U.S. NIH Grant/Contract ) DAIDS-ES ID 10731 ( Other Identifier: DAIDS )
Study First Received:	January 29, 2009
Results First Received:	October 15, 2015
Last Updated:	March 3, 2016

Keywords provided by Rajesh T. Gandhi, MD, Massachusetts General Hospital:


HIV vaccine Dendritic cells treatment experienced

Additional relevant MeSH terms:


Infection Communicable Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections	Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on July 17, 2017

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