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HIV InfectionPhase 1NCT02767193

Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated in HIV-1 Infected Patients

A Phase 1 study testing DCV3 and DCV3 with PEG-INF in people with HIV Infection, run by Judit Pich Martínez 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

single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective, placebo-controlled, partially masked, parallel group. Patients will be assigned to one of the following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells with pegylated interferon + / 3 immunizations… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
DCV3 and DCV3 with PEG-INF
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteSpain
Study dates
May 2016to 22 May 2019
Phase
Phase 1
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

  • Patient > 18 years of age;
  • Voluntarily sign informed consent;
  • Men or women with a negative pregnancy test before inclusion in the study;
  • HIV infection tested (with positive antibodies to HIV-1 and a detectable viral load);
  • Patient must be on stable treatment with cART at least 1 year
  • The average of all measurements of CD4 during the year before starting cART should be equal or greater than 350 cells / mm3
  • The number of CD4 + at enrollment must be equal or greater than 450 cells / mm3;
  • Plasma HIV viral load undetectable at least 6 months before the inclusion in the study, at least two determinations (occasional blips above the undetectable level are allowed).

Who cannot join

  • Treatment with suboptimal regimen (less than 3 antiretroviral drugs) before starting cART;
  • History of C CDC events;
  • Interruption of cART during the inclusion in the study;
  • Pregnancy woman or becoming pregnant in the next months;
  • Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;
  • Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gamma globulins or chemotherapy within 90 days prior to the screening visit;
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  • Use of anticoagulant medication;
  • Use of any investigational drug within 90 days prior to study entry;
  • Virological failure prior to antiretroviral treatment and / or mutations that confer resistance to antiretroviral drugs;
  • Uncontrolled psychiatric disorder;
  • Platelet count <80,000 / mm3;
  • Values ??of hemoglobin <12g / dL;
  • Patients with active uncontrolled autoimmune diseases;
  • Using contraindicated drugs in accordance with the Summary of Product Specifications of pegylated interferon;
  • Childbearing, or potential childbearing not using highly effective contraception;
  • Any other problem that according to the investigator could interfere with the evaluation of the objectives.
  • Any contraindication for the use of interferon peg in accordance with the Summary of Product Characteristics.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínic

    Barcelona, España, 08036

Other trials in Spain

About this study

Official title: Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated HIV in HIV-1 Infected Patients. Prospective, Randomized, Partially Blinded Study

single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective, placebo-controlled, partially masked, parallel group. Patients will be assigned to one of the following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo with pegylated interferon.

Conditions
HIV Infection
Being tested
DCV3, DCV3 with PEG-INF, Placebo, Placebo with PEG-INF
Medical subject headings
HIV Infections

What participants receive

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

  • DCV3Biological

    Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus.

    Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4

  • DCV3 with PEG-INFBiological

    Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus with PEG_INF Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4 and INF during weeks 4,5 and 6

  • PlaceboBiological

    Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4

  • Placebo with PEG-INFBiological

    Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG_INF Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4 and INF during weeks 4,5 and 6.

Study groups in NCT02767193
Study groupRoleWhat they receive
DCV3ExperimentalAutologus differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus
Receives: Biological: DCV3
DCV3 with PEG-INFExperimentalAutologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus with PEG-INF
Receives: Biological: DCV3 with PEG-INF
CD placeboPlacebo comparatorAutologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded
Receives: Biological: Placebo
CD placebo + PEG-INFPlacebo comparatorAutologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG-INF
Receives: Biological: Placebo with PEG-INF

What is being measured

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

  1. Number of Participants with adverse events of grade 3 or higher

    • Local adverse events of grade 3 or higher (pain and skin reactions including induration)
    • Systemic adverse events of grade 3 or higher (fever, chills, headache, nausea, vomiting, malaise and myalgia)
    • Clinical or laboratory confirmed grade 3 or higher on physical examination or retests adverse events Any event attributable to the vaccine involving a discontinuation of vaccination regime.

    Measured: 28 weeks

  2. Virological

    Proportion of patients with undetectable viral load (<37 copies / mL) at 12 weeks

    Measured: 12 weeks

Secondary outcomes (10)

  1. Number of adverse events grade 1 and 2 within 14 days after each immunization (weeks 2, 4 and 6)

    Measured: 6 weeks

  2. Changes in the specific immune response

    Measured by ELISPOT visits in weeks 2, 4, 8, 12, 16 and 28 compared to baseline and screening for dendritic cell vaccine and pegylated interferon.

    Measured: 28 weeks

  3. Changes in levels of viral reservoir.

    Measure the proviral DNA visits in the weeks -44, -36, 4, 8, 12, 16 and 28 compared to baseline and screening.

    Measured: 28 weeks

  4. Proportion of patients with changes in any value of the levels of inflammatory markers, microbial translocation and immune activation

    In visits at weeks 4, 16 and 28 compared compared to baseline and screening

    Measured: 28 weeks

  5. Proportion of patients with viral rebound

    Two consecutive obtaining measurements of plasma viral load> 37 copies / mL separated by at least 15 days after discontinuation of antiretroviral therapy.

    Measured: 15 days

  6. Proportion of patients with autoimmunity markers induced by the vaccine as measured by: antithyroid antibodies (antithyroglobulin, antithyroid peroxidase), antinuclear antibodies, antiphospholipid antibodies and rheumatoid factors.

    Evaluation on autoimmunity with antithyroid antibodies (antithyroglobulin, antithyroid peroxidase), antinuclear antibodies, antiphospholipid antibodies and rheumatoid factor at screening, baseline and week 16.

    Measured: 16 weeks

  7. Changes in the transcriptome of patients visits weeks 4, 16 and 28 compared to baseline (week -12)

    Weeks 4, 16 and 28 compared to baseline

    Measured: 28 weeks

  8. Evaluation of the specific immune response trought IFN-gamma production in vitro at screening and baseline

    Proportion of patients with IFN-gamma production in vitro measured by ELISPOT at screening and baseline

    Measured: week 0

  9. Evaluation of the specific immune response thought dendritic cell maturation markers in vitro at screening and baseline

    Proportion of patients with dendritic cell maturation markers in vitro measured by flow cytometry at screening and baseline

    Measured: week 0

  10. Evaluation of the specific immune response thought T-cell proliferation in vitro at screening and baseline

    Proportion of patients with T-cell proliferation in vitro measured by CFSE (carboxyfluorescein succinimidyl ester) at screening and baseline

    Measured: week 0

Timeline

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

  1. First posted10 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion22 May 2019
  4. Study completion22 May 2019

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02767193
Sponsor's protocol ID
DCV3/RisVac04
Other IDs
2015-001795-22, 2015
Status last verified
Jul 2019
First submitted
22 Apr 2016
Last updated
26 Jul 2019
Results posted
No
Data monitoring committee
No

Publications

  • Leal L, Couto E, Sanchez-Palomino S, Climent N, Fernandez I, Miralles L, Romero Y, Gonzalez T, Maleno MJ, Pano B, Pich J, Nicolau C, Gatell JM, Plana M, Garcia F; DCV3-RISVAC04 Study Group. Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon alpha-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial. Front Immunol. 2021 Nov 11;12:767370. doi: 10.3389/fimmu.2021.767370. eCollection 2021.

    PubMed 34858423

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DCV3 and DCV3 with PEG-INF in people with HIV Infection, run by Judit Pich Martínez at 1 site in Spain.

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 8 inclusion and 17 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 Jul 2019. 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 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.

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?

Number of Participants with adverse events of grade 3 or higher (time frame: 28 weeks). 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 NCT02767193, 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 26 Jul 2019.

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