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

NCT ID: NCT02767193

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-05-22

Brief 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 of placebo / 3 immunizations of placebo with pegylated interferon.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DCV3

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

Group Type: EXPERIMENTAL

DCV3

Intervention Type: BIOLOGICAL

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-INF

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

Group Type: EXPERIMENTAL

DCV3 with PEG-INF

Intervention Type: BIOLOGICAL

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

CD placebo

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

CD placebo + PEG-INF

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG-INF

Group Type: PLACEBO_COMPARATOR

Placebo with PEG-INF

Intervention Type: BIOLOGICAL

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.

Interventions

DCV3

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

Intervention Type: BIOLOGICAL

DCV3 with PEG-INF

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

Placebo with PEG-INF

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patient > 18 years of age;

2. Voluntarily sign informed consent;

3. Men or women with a negative pregnancy test before inclusion in the study;

4. HIV infection tested (with positive antibodies to HIV-1 and a detectable viral load);

5. Patient must be on stable treatment with cART at least 1 year

6. The average of all measurements of CD4 during the year before starting cART should be equal or greater than 350 cells / mm3

7. The number of CD4 + at enrollment must be equal or greater than 450 cells / mm3;

8. 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).

Exclusion Criteria

1. Treatment with suboptimal regimen (less than 3 antiretroviral drugs) before starting cART;

2. History of C CDC events;

3. Interruption of cART during the inclusion in the study;

4. Pregnancy woman or becoming pregnant in the next months;

5. Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;

6. Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gamma globulins or chemotherapy within 90 days prior to the screening visit;

7. Use of anticoagulant medication;

8. Use of any investigational drug within 90 days prior to study entry;

9. Virological failure prior to antiretroviral treatment and / or mutations that confer resistance to antiretroviral drugs;

10. Uncontrolled psychiatric disorder;

11. Platelet count <80,000 / mm3;

12. Values ??of hemoglobin <12g / dL;

13. Patients with active uncontrolled autoimmune diseases;

14. Using contraindicated drugs in accordance with the Summary of Product Specifications of pegylated interferon;

15. Childbearing, or potential childbearing not using highly effective contraception;

16. Any other problem that according to the investigator could interfere with the evaluation of the objectives.

17. Any contraindication for the use of interferon peg in accordance with the Summary of Product Characteristics.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Judit Pich Martínez

OTHER

Sponsor Role: lead

Responsible Party

Judit Pich Martínez

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Clínic

Barcelona, España, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 34858423 (View on PubMed)

Other Identifiers

2015-001795-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DCV3/RisVac04

Identifier Type: -

Identifier Source: org_study_id