NCT00833781

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 8, 2016

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

4.3 years

First QC Date

January 29, 2009

Results QC Date

October 15, 2015

Last Update Submit

March 3, 2016

Conditions

HIV-1 InfectionHIV Infections

Keywords

HIV vaccineDendritic cellstreatment experienced

Outcome Measures

Primary Outcomes (2)

  • Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)

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

    After vaccination

  • Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef

    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.

    Baseline and 14 weeks

Secondary Outcomes (2)

  • T Cell Proliferation

    Baseline to week 14

  • IL2 and IFN Gamma Production

    Baseline to week 14

Study Arms (2)

mRNA-transfected dendritic cells

ACTIVE COMPARATOR

Participants in this arm/group received mRNA-transfected autologous dendritic cells

Biological: mRNA-transfected autologous dendritic cells

Dendritic cells without mRNA

PLACEBO COMPARATOR

Participants in this arm/group received autologous dendritic cells with no mRNA transfection

Biological: autologous dendritic cells with no mRNA transfection

Interventions

mRNA-transfected autologous dendritic cellsBIOLOGICAL

Injections will be administered intradermally at weeks 0, 2, 6 and 10.

mRNA-transfected dendritic cells
autologous dendritic cells with no mRNA transfectionBIOLOGICAL

Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Also known as: Autologous dendritic cells not transfected with mRNA.
Dendritic cells without mRNA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hepatitis C positive
  • Detectable HIV viral load within 6 months prior to study entry
  • Females who are pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Disease Unit; Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 26379068BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

RNA, Messenger

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

RNANucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

The trial size is small, precluding detection of small effect sizes.

Results Point of Contact

Title
Dr. Rajesh Gandhi
Organization
Mass General Hospital
rgandhi@partners.org
617-724-9690

Study Officials

  • Rajesh Gandhi, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Education

Study Record Dates

First Submitted

January 29, 2009

First Posted

February 2, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 8, 2016

Results First Posted

March 8, 2016

Record last verified: 2016-03

Locations

US(1)