HIV-1 InfectionPhase 1/2PARC002NCT00833781

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

A Phase 1/2 study testing mRNA-transfected autologous dendritic cells and autologous dendritic cells with no mRNA transfection in people with HIV-1 Infection and HIV Infections, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV-1 Infection, HIV Infections
What is being tested?: mRNA-transfected autologous dendritic cells and autologous dendritic cells with no mRNA transfection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Aug 2009to Dec 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Infectious Disease Unit; Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Pilot, Double-blind, Placebo-controlled, Randomized Clinical Trial of mRNA-transfected Autologous Dendritic Cells in Subjects With Well-controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy

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.

Read the detailed description

This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.

Conditions: HIV-1 Infection, HIV Infections
Being tested: mRNA-transfected autologous dendritic cells, autologous dendritic cells with no mRNA transfection
Keywords: HIV vaccine, Dendritic cells, treatment experienced
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mRNA-transfected autologous dendritic cellsBiological
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
autologous dendritic cells with no mRNA transfectionBiological
Also called Autologous dendritic cells not transfected with mRNA.
Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Study groups in NCT00833781
Study group	Role	What they receive
mRNA-transfected dendritic cells	Active comparator	Participants in this arm/group received mRNA-transfected autologous dendritic cells Receives: 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 Receives: Biological: autologous dendritic cells with no mRNA transfection

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Baseline and 14 weeks

Secondary outcomes (2)

T Cell Proliferation
Measured: Baseline to week 14
IL2 and IFN Gamma Production
Measured: Baseline to week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Dec 2013

First posted2 Feb 2009 (estimated)
Study startAug 2009
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00833781
Sponsor's protocol ID: 2008p001577
Other IDs: R01AI066992-04, DAIDS-ES ID 10731
Acronym: PARC002
Status last verified: Mar 2016
First submitted: 29 Jan 2009
Last updated: 8 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 26379068

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot, Double-blind, Placebo-controlled, Randomized Clinical Trial of mRNA-transfected Autologous Dendritic Cells in Subjects With Well-controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy
ClinicalTrials.gov ID: NCT00833781
Acronym / sponsor ID: PARC002 / 2008p001577
Conditions: HIV-1 Infection, HIV Infections
Keywords: HIV vaccine, Dendritic cells, treatment experienced
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Aug 2009
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 2 Feb 2009 (estimated)
Results: Posted 8 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
mRNA-transfected dendritic cells	Active comparator	Biological: mRNA-transfected autologous dendritic cellsParticipants in this arm/group received mRNA-transfected autologous dendritic cells
Dendritic cells without mRNA	Placebo comparator	Biological: autologous dendritic cells with no mRNA transfectionParticipants in this arm/group received autologous dendritic cells with no mRNA transfection

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mRNA-transfected autologous dendritic cellsInjections will be administered intradermally at weeks 0, 2, 6 and 10.	Biological	mRNA-transfected dendritic cells
autologous dendritic cells with no mRNA transfectionAlso: Autologous dendritic cells not transfected with mRNA.Injections will be administered intradermally at weeks 0, 2, 6 and 10.	Biological	Dendritic cells without mRNA

Primary outcome

Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)
Time frame: After vaccination
Number of participants with grade 3 or 4 adverse events related to vaccination
Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef
Time frame: 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.

2 secondary outcomes

T Cell Proliferation
Time frame: Baseline to week 14
IL2 and IFN Gamma Production
Time frame: Baseline to week 14

Results and safety

Results posted to the registry on 8 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mRNA-transfected Autologous Dendritic Cell Vaccine.	10	10
Autologous Dendritic Cells Without Transfected mRNA.	5	5

Primary outcome: Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)

Time frame: After vaccination. Number. Unit: participants

Measure	mRNA-transfected Autologous Dendritic Cells n = 10	Dendritic Cell Vaccine Without Transfected mRNA. n = 5
Value	0	0

Primary outcome: Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef

Time frame: Baseline and 14 weeks. Median (Full Range). Unit: fold ratio

Measure	mRNA-transfected Autologous Dendritic Cells n = 10	Dendritic Cell Vaccine Without Transfected mRNA. n = 5
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)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mRNA Transfected DCs	0 of 15 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): The trial size is small, precluding detection of small effect sizes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26379068Gandhi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rajesh Gandhi, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of the DC Vaccine (as Measured by Frequency of Adverse Events) (time frame: After vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00833781, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.