Trial Outcomes & Findings for A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects (NCT NCT00833781)

NCT ID: NCT00833781

Last Updated: 2016-03-08

Results Overview

Number of participants with grade 3 or 4 adverse events related to vaccination

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: After vaccination
• Results posted on: 2016-03-08

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	10	5
Overall Study COMPLETED	10	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	mRNA-transfected Autologous Dendritic Cell Vaccine. n=10 Participants mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.	Autologous Dendritic Cells Without Transfected mRNA. n=5 Participants 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 n=15 Participants Total of all reporting groups
Age, Continuous	44 years n=5 Participants	49 years n=7 Participants	46.7 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: After vaccination

Number of participants with grade 3 or 4 adverse events related to vaccination

Outcome measures

Measure	mRNA-transfected Autologous Dendritic Cells n=10 Participants Injections were administered intradermally at weeks 0, 2, 6 and 10.	Dendritic Cell Vaccine Without Transfected mRNA. n=5 Participants Injections were administered intradermally at weeks 0, 2, 6 and 10.
Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)	0 participants	0 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	mRNA-transfected Autologous Dendritic Cells n=10 Participants Injections were administered intradermally at weeks 0, 2, 6 and 10.	Dendritic Cell Vaccine Without Transfected mRNA. n=5 Participants Injections were administered intradermally at weeks 0, 2, 6 and 10.
Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef Gag ELISPOT	1.06 fold ratio Interval 0.893 to 1.259	1.058 fold ratio Interval 0.836 to 1.33
Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef Nef ELISPOT	1.15 fold ratio Interval 0.979 to 1.351	1.021 fold ratio Interval 0.813 to 1.281

SECONDARY outcome

Timeframe: Baseline to week 14

Outcome measures

Measure	mRNA-transfected Autologous Dendritic Cells n=10 Participants Injections were administered intradermally at weeks 0, 2, 6 and 10.	Dendritic Cell Vaccine Without Transfected mRNA. n=5 Participants Injections were administered intradermally at weeks 0, 2, 6 and 10.
T Cell Proliferation CD4 Gag proliferative response	2.465 fold change Interval 1.167 to 5.208	0.717 fold change Interval 0.253 to 2.033
T Cell Proliferation CD4 Nef Proliferative response	2.292 fold change Interval 1.044 to 5.035	0.363 fold change Interval 0.12 to 1.102

SECONDARY outcome

Timeframe: Baseline to week 14

Population: Results from these assays were too variable to be interpretable.

Outcome measures

Outcome data not reported

Adverse Events

mRNA Transfected DCs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rajesh Gandhi

Mass General Hospital

Phone: 617-724-9690

Email: rgandhi@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place