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

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ClinicalTrials.gov Identifier: NCT00833781
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Rajesh T. Gandhi, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions HIV-1 Infection
HIV Infections
Interventions Biological: mRNA-transfected autologous dendritic cells
Biological: autologous dendritic cells with no mRNA transfection
Enrollment 15

Recruitment Details  
Pre-assignment Details  
Arm/Group Title mRNA-transfected Autologous Dendritic Cell Vaccine. Autologous Dendritic Cells Without Transfected mRNA.
Hide Arm/Group Description mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Dendritic cell vaccine without transfected mRNA.

Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Period Title: Overall Study
Started 10 5
Completed 10 5
Not Completed 0 0
Arm/Group Title mRNA-transfected Autologous Dendritic Cell Vaccine. Autologous Dendritic Cells Without Transfected mRNA. Total
Hide Arm/Group Description mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Dendritic cell vaccine without transfected mRNA.

Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Total of all reporting groups
Overall Number of Baseline Participants 10 5 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 5 participants 15 participants
44
(33 to 55)
49
(42 to 52)
46.7
(33 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 5 participants 15 participants
Female
3
  30.0%
0
   0.0%
3
  20.0%
Male
7
  70.0%
5
 100.0%
12
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 5 participants 15 participants
10 5 15
1.Primary Outcome
Title Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)
Hide Description Number of participants with grade 3 or 4 adverse events related to vaccination
Time Frame After vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title mRNA-transfected Autologous Dendritic Cells Dendritic Cell Vaccine Without Transfected mRNA.
Hide Arm/Group Description:
Injections were administered intradermally at weeks 0, 2, 6 and 10.
Injections were administered intradermally at weeks 0, 2, 6 and 10.
Overall Number of Participants Analyzed 10 5
Measure Type: Number
Unit of Measure: participants
0 0
2.Primary Outcome
Title Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef
Hide Description 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.
Time Frame Baseline and 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title mRNA-transfected Autologous Dendritic Cells Dendritic Cell Vaccine Without Transfected mRNA.
Hide Arm/Group Description:
Injections were administered intradermally at weeks 0, 2, 6 and 10.
Injections were administered intradermally at weeks 0, 2, 6 and 10.
Overall Number of Participants Analyzed 10 5
Median (Full Range)
Unit of Measure: fold ratio
Gag ELISPOT
1.06
(0.893 to 1.259)
1.058
(0.836 to 1.33)
Nef ELISPOT
1.15
(0.979 to 1.351)
1.021
(0.813 to 1.281)
3.Secondary Outcome
Title T Cell Proliferation
Hide Description [Not Specified]
Time Frame Baseline to week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title mRNA-transfected Autologous Dendritic Cells Dendritic Cell Vaccine Without Transfected mRNA.
Hide Arm/Group Description:
Injections were administered intradermally at weeks 0, 2, 6 and 10.
Injections were administered intradermally at weeks 0, 2, 6 and 10.
Overall Number of Participants Analyzed 10 5
Mean (95% Confidence Interval)
Unit of Measure: fold change
CD4 Gag proliferative response
2.465
(1.167 to 5.208)
0.717
(0.253 to 2.033)
CD4 Nef Proliferative response
2.292
(1.044 to 5.035)
0.363
(0.12 to 1.102)
4.Secondary Outcome
Title IL2 and IFN Gamma Production
Hide Description [Not Specified]
Time Frame Baseline to week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results from these assays were too variable to be interpretable.
Arm/Group Title mRNA-transfected Autologous Dendritic Cells Dendritic Cell Vaccine Without Transfected mRNA.
Hide Arm/Group Description:
Injections were administered intradermally at weeks 0, 2, 6 and 10.
Injections were administered intradermally at weeks 0, 2, 6 and 10.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title mRNA Transfected DCs
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
mRNA Transfected DCs
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
mRNA Transfected DCs
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
mRNA Transfected DCs
Affected / at Risk (%)
Total   0/15 (0.00%) 
The trial size is small, precluding detection of small effect sizes.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Rajesh Gandhi
Organization: Mass General Hospital
Phone: 617-724-9690
Publications:
Responsible Party: Rajesh T. Gandhi, MD, 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 )
First Submitted: January 29, 2009
First Posted: February 2, 2009
Results First Submitted: October 15, 2015
Results First Posted: March 8, 2016
Last Update Posted: March 8, 2016