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
Results First Received: October 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
mRNA-transfected Autologous Dendritic Cell Vaccine. mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Autologous Dendritic Cells Without Transfected mRNA.

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.


Participant Flow:   Overall Study
    mRNA-transfected Autologous Dendritic Cell Vaccine.     Autologous Dendritic Cells Without Transfected mRNA.  
STARTED     10     5  
COMPLETED     10     5  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
mRNA-transfected Autologous Dendritic Cell Vaccine. mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Autologous Dendritic Cells Without Transfected mRNA.

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 Total of all reporting groups

Baseline Measures
    mRNA-transfected Autologous Dendritic Cell Vaccine.     Autologous Dendritic Cells Without Transfected mRNA.     Total  
Number of Participants  
[units: participants]
  10     5     15  
Age  
[units: years]
Median (Full Range)
  44   (33 to 55)     49   (42 to 52)     46.7   (33 to 55)  
Gender  
[units: participants]
     
Female     3     0     3  
Male     7     5     12  
Region of Enrollment  
[units: participants]
     
United States     10     5     15  



  Outcome Measures
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1.  Primary:   Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)   [ Time Frame: After vaccination ]

2.  Primary:   Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef   [ Time Frame: Baseline and 14 weeks ]

3.  Secondary:   T Cell Proliferation   [ Time Frame: Baseline to week 14 ]

4.  Secondary:   IL2 and IFN Gamma Production   [ Time Frame: Baseline to week 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial size is small, precluding detection of small effect sizes.


  More Information
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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
e-mail: rgandhi@partners.org


Publications:

Responsible Party: Rajesh T. Gandhi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833781     History of Changes
Other Study ID Numbers: 2008p001577
R01AI066992-04 ( US NIH Grant/Contract Award Number )
DAIDS-ES ID 10731 ( Other Identifier: DAIDS )
Study First Received: January 29, 2009
Results First Received: October 15, 2015
Last Updated: March 3, 2016
Health Authority: United States: Food and Drug Administration