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

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

Participant Flow

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Recruitment Details
Pre-assignment Details

Arm/Group Title	mRNA-transfected Autologous Dendritic Cell Vaccine.	Autologous Dendritic Cells Without Transfected mRNA.
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

Baseline Characteristics

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Arm/Group Title		mRNA-transfected Autologous Dendritic Cell Vaccine.	Autologous Dendritic Cells Without Transfected mRNA.	Total
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
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

Outcome Measures

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1. Primary Outcome

Title	Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)
Description	Number of participants with grade 3 or 4 adverse events related to vaccination
Time Frame	After vaccination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	mRNA-transfected Autologous Dendritic Cells	Dendritic Cell Vaccine Without Transfected mRNA.
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	mRNA-transfected Autologous Dendritic Cells	Dendritic Cell Vaccine Without Transfected mRNA.
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
Description	[Not Specified]
Time Frame	Baseline to week 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	mRNA-transfected Autologous Dendritic Cells	Dendritic Cell Vaccine Without Transfected mRNA.
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
Description	[Not Specified]
Time Frame	Baseline to week 14

Outcome Measure Data

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.
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.

Adverse Events

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Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	mRNA Transfected DCs
Arm/Group Description	[Not Specified]
All-Cause Mortality
	mRNA Transfected DCs
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	mRNA Transfected DCs
	Affected / at Risk (%)
Total	0/15 (0.00%)
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%)

Limitations and Caveats

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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

EMail: rgandhi@partners.org

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, 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