HIV InfectionsPhase 1/2NCT00402142

Dendritic Cell Vaccine in HIV-1 Infection

A Phase 1/2 study testing Dendritic cell vaccine, non pulsed dendritic cell untreated patients and pulsed dendritic cell vaccine in people with HIV Infections, run by Hospital Clinic of Barcelona at 1 site in Spain.

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

1. To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1 infected patients in a very early stages of the disease (CD4 > 450 x 10 6 /L). 2. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Dendritic cell vaccine, non pulsed dendritic cell untreated patients and pulsed dendritic cell vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteSpain
Study dates: Nov 2006to Dec 2011
Phase: Phase 1/2
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed HIV infection
CD4 > 450 x 10 6 /L
baseline VL >10,000 c/ml before any HAART
Part I, patients off HAART at least during 6 months
Part II, Patients on HAART with PVL < 200 copies/ml at least during 6 months
Written informed consent .

Who cannot join

Patients with failure to HAART
Patients with B or C symptoms (CDC classification 1993).
Age < 18 years old.
Pregnant or breastfeeding women
Patients with baseline creatinin > 2.5 mg/dl
Patients with baseline GOT/GPT > 250 UI/L

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clínic
Barcelona, Barcelona, 08036

Other trials in Spain

About this study

Official title: Phase II Study of Autologous Myeloid Dendritic Cells as a "Cellular Adjuvant" for a Therapeutic HIV-1 Vaccine in Early Stage HIV-1+ Patients (DCV-2).

To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1 infected patients in a very early stages of the disease (CD4 > 450 x 10 6 /L).
To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy.

Read the detailed description

Our group has reported recently the first human trial of 4 therapeutic immunizations at six-week intervals with autologous monocyte-derived dendritic cells (MD-DC) loaded with heat-inactivated autologous HIV in 12 HIV infected patients who had been receiving highly active antiretroviral therapy (HAART) since early chronic infection. Autologous HIV was concentrated from plasma (1,500 ml) obtained by plasmapheresis after a 3-month HAART interruption (STOP1) performed 78 weeks before therapeutic immunizations, and HAART was discontinued again (STOP2) after therapeutic immunization. There was a decrease of set-point plasma viral load (PVL) >= 0.5 log after 24 weeks off HAART in 4 out of 12 patients. In addition, we observed a significant lengthening in mean doubling time of PVL rebound (p= 0.01), and significant decreases in the area under the curve of PVL rebound (p= 0.02) and in the mean peak PVL (p= 0.004) during the 12 weeks after STOP 2 compared with STOP1. This virological response was associated with a weak but significant increase in HIV-1 specific CD4 lymphoproliferative response, and with changes in HIV-1 specific CD8+ T-cell responses in peripheral blood and in lymphoid CTL cells after immunization. In lymphoid tissue, we also observed a trend towards a better control of HIV-1 replication coupled with an increase of CD4+ and CTL cells. No significant virological or immunological changes occurred in controls. We show that a therapeutic vaccine with autologous MD-DC pulsed with heat inactivated autologous HIV-1 is feasible, safe and well tolerated and elicited weak and transient cellular immune responses against HIV, associated with a partial and transient control of HIV replication in some patients.

we hypothesized that a DC vaccine pulsed with higher amount of autologous virus obtained by culture could be more effective than the vaccine we used.

Conditions: HIV Infections
Being tested: Dendritic cell vaccine, non pulsed dendritic cell untreated patients, pulsed dendritic cell vaccine, non pulsed dendritic cell vaccine
Keywords: HIV Infection, Dendritic cell vaccine, Autologous virus, Heat inactivated, HIV Therapeutic Vaccine
Medical subject headings: HIV Infections

What participants receive

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

Dendritic cell vaccineBiological
107 DC subcutaneous 3 doses every 2 weeks
non pulsed dendritic cell untreated patientsBiological
107 DC subcutaneous 3 doses every 2 weeks
pulsed dendritic cell vaccineBiological
107 DC subcutaneous 3 doses every 2 weeks
dendritic cell vaccineBiological
107 DC subcutaneous 3 doses every 2 weeks
non pulsed dendritic cell vaccineBiological
107 DC subcutaneous 3 doses every 2 weeks

Study groups in NCT00402142
Study group	Role	What they receive
Pulsed dendritic cells untreated patients	Active comparator	Untreated patients receiving a dendritic cell based vaccine pulsed with autologous heat iactivated virus Receives: Biological: Dendritic cell vaccine
non pulsed dendritic cells untreated patients	Placebo comparator	Not described Receives: Biological: non pulsed dendritic cell untreated patients
pulsed dendritic cell treated patient	Active comparator	treated patients will be immunized with a dendritic cell vaccine pulsed with heat inactivated autologous virus immediately before art interruption Receives: Biological: pulsed dendritic cell vaccine
pulsed dendritic cell in treated patients	Active comparator	patients will be immunized with a dendritic cell vaccine pulsed with heat inactivted autologous virus immediately after interruption of art Receives: Biological: dendritic cell vaccine
non pulsed dendritic cells	Placebo comparator	Not described Receives: Biological: non pulsed dendritic cell vaccine

What is being measured

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

Comparison of steady state viremia (so-called viral set point) after 6-12 months after vaccination with viremia before HAART.
Measured: 6 and 12 months

Secondary outcomes (6)

Proportion with evidence of HIV-specific CTL comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.
Measured: 6 and 12 months
Proportion with evidence of HIV-specific T-cell proliferative response comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.
Measured: 6 and 12 months
Proportion with evidence of HIV-specific neutralizing activity of serum comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.
Measured: 6 and 12 months
HIV-1 specific CTL responses in lymphoid tissue
Measured: 0 and 6 months
DC Migration
Measured: 0 and 2 weeks
Viral load in semen and vaginal secretions
Measured: 0 and 6 months

Timeline

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

Nov 2006Dec 2011

First posted22 Nov 2006 (estimated)
Study startNov 2006
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Hospital Clinic of BarcelonaThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00402142
Sponsor's protocol ID: DCV-02/MANON07
Status last verified: Feb 2014
First submitted: 17 Nov 2006
Last updated: 26 Feb 2014
Results posted: No
Data monitoring committee: Yes

Publications

Garcia F, Lejeune M, Climent N, Gil C, Alcami J, Morente V, Alos L, Ruiz A, Setoain J, Fumero E, Castro P, Lopez A, Cruceta A, Piera C, Florence E, Pereira A, Libois A, Gonzalez N, Guila M, Caballero M, Lomena F, Joseph J, Miro JM, Pumarola T, Plana M, Gatell JM, Gallart T. Therapeutic immunization with dendritic cells loaded with heat-inactivated autologous HIV-1 in patients with chronic HIV-1 infection. J Infect Dis. 2005 May 15;191(10):1680-5. doi: 10.1086/429340. Epub 2005 Apr 11.
PubMed 15838795
Garcia F, Climent N, Guardo AC, Gil C, Leon A, Autran B, Lifson JD, Martinez-Picado J, Dalmau J, Clotet B, Gatell JM, Plana M, Gallart T; DCV2/MANON07-ORVACS Study Group. A dendritic cell-based vaccine elicits T cell responses associated with control of HIV-1 replication. Sci Transl Med. 2013 Jan 2;5(166):166ra2. doi: 10.1126/scitranslmed.3004682.
PubMed 23283367
Garcia F, Climent N, Assoumou L, Gil C, Gonzalez N, Alcami J, Leon A, Romeu J, Dalmau J, Martinez-Picado J, Lifson J, Autran B, Costagliola D, Clotet B, Gatell JM, Plana M, Gallart T; DCV2/MANON07- AIDS Vaccine Research Objective Study Group. A therapeutic dendritic cell-based vaccine for HIV-1 infection. J Infect Dis. 2011 Feb 15;203(4):473-8. doi: 10.1093/infdis/jiq077. Epub 2011 Jan 13.
PubMed 21233310
Andres C, Plana M, Guardo AC, Alvarez-Fernandez C, Climent N, Gallart T, Leon A, Clotet B, Autran B, Chomont N, Gatell JM, Sanchez-Palomino S, Garcia F. HIV-1 Reservoir Dynamics after Vaccination and Antiretroviral Therapy Interruption Are Associated with Dendritic Cell Vaccine-Induced T Cell Responses. J Virol. 2015 Sep;89(18):9189-99. doi: 10.1128/JVI.01062-15. Epub 2015 Jun 24.
PubMed 26109727
Gil C, Climent N, Garcia F, Hurtado C, Nieto-Marquez S, Leon A, Garcia MT, Rovira C, Miralles L, Dalmau J, Pumarola T, Almela M, Martinez-Picado J, Lifson JD, Zamora L, Miro JM, Brander C, Clotet B, Gallart T, Gatell JM. Ex vivo production of autologous whole inactivated HIV-1 for clinical use in therapeutic vaccines. Vaccine. 2011 Aug 5;29(34):5711-24. doi: 10.1016/j.vaccine.2011.05.096. Epub 2011 Jun 14.
PubMed 21679735

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?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Autologous Myeloid Dendritic Cells as a "Cellular Adjuvant" for a Therapeutic HIV-1 Vaccine in Early Stage HIV-1+ Patients (DCV-2).
ClinicalTrials.gov ID: NCT00402142
Acronym / sponsor ID: DCV-02/MANON07
Conditions: HIV Infections
Keywords: HIV Infection, Dendritic cell vaccine, Autologous virus, Heat inactivated, HIV Therapeutic Vaccine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Hospital Clinic of BarcelonaUniversity, hospital or other
Study start: Nov 2006
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Not posted in the source record

Clinical summary

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

To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1 infected patients in a very early stages of the disease (CD4 > 450 x 10 6 /L).
To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy.

Detailed description

we hypothesized that a DC vaccine pulsed with higher amount of autologous virus obtained by culture could be more effective than the vaccine we used.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Pulsed dendritic cells untreated patients	Active comparator	Biological: Dendritic cell vaccineUntreated patients receiving a dendritic cell based vaccine pulsed with autologous heat iactivated virus
non pulsed dendritic cells untreated patients	Placebo comparator	Biological: non pulsed dendritic cell untreated patients
pulsed dendritic cell treated patient	Active comparator	Biological: pulsed dendritic cell vaccinetreated patients will be immunized with a dendritic cell vaccine pulsed with heat inactivated autologous virus immediately before art interruption
pulsed dendritic cell in treated patients	Active comparator	Biological: dendritic cell vaccinepatients will be immunized with a dendritic cell vaccine pulsed with heat inactivted autologous virus immediately after interruption of art
non pulsed dendritic cells	Placebo comparator	Biological: non pulsed dendritic cell vaccine

Who may qualify

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

Key inclusion criteria (6 listed)

Confirmed HIV infection
CD4 > 450 x 10 6 /L
baseline VL >10,000 c/ml before any HAART
Part I, patients off HAART at least during 6 months
Part II, Patients on HAART with PVL < 200 copies/ml at least during 6 months

Key exclusion criteria (6 listed)

Patients with failure to HAART
Patients with B or C symptoms (CDC classification 1993).
Age < 18 years old.
Pregnant or breastfeeding women
Patients with baseline creatinin > 2.5 mg/dl

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
Dendritic cell vaccine107 DC subcutaneous 3 doses every 2 weeks	Biological	Pulsed dendritic cells untreated patients
non pulsed dendritic cell untreated patients107 DC subcutaneous 3 doses every 2 weeks	Biological	non pulsed dendritic cells untreated patients
pulsed dendritic cell vaccine107 DC subcutaneous 3 doses every 2 weeks	Biological	pulsed dendritic cell treated patient
dendritic cell vaccine107 DC subcutaneous 3 doses every 2 weeks	Biological	pulsed dendritic cell in treated patients
non pulsed dendritic cell vaccine107 DC subcutaneous 3 doses every 2 weeks	Biological	non pulsed dendritic cells

Primary outcome

Comparison of steady state viremia (so-called viral set point) after 6-12 months after vaccination with viremia before HAART.
Time frame: 6 and 12 months

6 secondary outcomes

Proportion with evidence of HIV-specific CTL comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.
Time frame: 6 and 12 months
Proportion with evidence of HIV-specific T-cell proliferative response comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.
Time frame: 6 and 12 months
Proportion with evidence of HIV-specific neutralizing activity of serum comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy.
Time frame: 6 and 12 months
HIV-1 specific CTL responses in lymphoid tissue
Time frame: 0 and 6 months
DC Migration
Time frame: 0 and 2 weeks
Viral load in semen and vaginal secretions
Time frame: 0 and 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
Background: PubMed 15838795Garcia F, Lejeune M, Climent N, Gil C, Alcami J, Morente V, Alos L, Ruiz A, Setoain J, Fumero E, Castro P, Lopez A, Cruceta A, Piera C, Florence E, Pereira A, Libois A, Gonzalez N, Guila M, Caballero M, Lomena F, Joseph J, Miro JM, Pumarola T, Plana M, Gatell JM, Gallart T. Therapeutic immunization with dendritic cells loaded with heat-inactivated autologous HIV-1 in patients with chronic HIV-1 infection. J Infect Dis. 2005 May 15;191(10):1680-5. doi: 10.1086/429340. Epub 2005 Apr 11.
Results publication: PubMed 23283367Garcia F, Climent N, Guardo AC, Gil C, Leon A, Autran B, Lifson JD, Martinez-Picado J, Dalmau J, Clotet B, Gatell JM, Plana M, Gallart T; DCV2/MANON07-ORVACS Study Group. A dendritic cell-based vaccine elicits T cell responses associated with control of HIV-1 replication. Sci Transl Med. 2013 Jan 2;5(166):166ra2. doi: 10.1126/scitranslmed.3004682.
Results publication: PubMed 21233310Garcia F, Climent N, Assoumou L, Gil C, Gonzalez N, Alcami J, Leon A, Romeu J, Dalmau J, Martinez-Picado J, Lifson J, Autran B, Costagliola D, Clotet B, Gatell JM, Plana M, Gallart T; DCV2/MANON07- AIDS Vaccine Research Objective Study Group. A therapeutic dendritic cell-based vaccine for HIV-1 infection. J Infect Dis. 2011 Feb 15;203(4):473-8. doi: 10.1093/infdis/jiq077. Epub 2011 Jan 13.
Derived from this study: PubMed 26109727Andres C, Plana M, Guardo AC, Alvarez-Fernandez C, Climent N, Gallart T, Leon A, Clotet B, Autran B, Chomont N, Gatell JM, Sanchez-Palomino S, Garcia F. HIV-1 Reservoir Dynamics after Vaccination and Antiretroviral Therapy Interruption Are Associated with Dendritic Cell Vaccine-Induced T Cell Responses. J Virol. 2015 Sep;89(18):9189-99. doi: 10.1128/JVI.01062-15. Epub 2015 Jun 24.
Derived from this study: PubMed 21679735Gil C, Climent N, Garcia F, Hurtado C, Nieto-Marquez S, Leon A, Garcia MT, Rovira C, Miralles L, Dalmau J, Pumarola T, Almela M, Martinez-Picado J, Lifson JD, Zamora L, Miro JM, Brander C, Clotet B, Gallart T, Gatell JM. Ex vivo production of autologous whole inactivated HIV-1 for clinical use in therapeutic vaccines. Vaccine. 2011 Aug 5;29(34):5711-24. doi: 10.1016/j.vaccine.2011.05.096. Epub 2011 Jun 14.

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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.

Felipe García, MD, PhD principal investigator

Hospital Clínic

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 6 inclusion and 6 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 26 Feb 2014. 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Comparison of steady state viremia (so-called viral set point) after 6-12 months after vaccination with viremia before HAART. (time frame: 6 and 12 months). 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 NCT00402142, which also lists 5 linked publications.

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 26 Feb 2014.