Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected Individuals

NCT05786937 | Unknown Phase 1

• 1 other identifier: INHC031
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to validate the strategy of adjuvant therapy with dendritic cells in HIV infection in chronically infected individuals. The main questions it aims to answer are related to the safety and tolerance of the intervention and the virological and immunological impact of immunotherapy with aDC1 in HIV-infected individuals. The study will include 30 diagnosed HIV-infected patients, using antiretroviral therapy, who will be immunized with aDC1 or placebo according to the arms of this study: G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART.

Conditions

HIV Vaccine

Keywords

HIV; Immunotherapy; Polarizing dendritic cells

Outcome Measures

Primary Outcomes (3)

• Adverse events related to the study product

  Number of participants with adverse events related to the study product

  Six months

• Plasma viral load setpoint after the intervention

  Number of participants with changes in the plasma viral load setpoint after the intervention

  Six months

• Setpoint of CD4+ T lymphocyte count after the intervention

  Number of participants with changes in the setpoint of CD4+ T lymphocyte count after the intervention

  Six months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The participants will receive a placebo, which is the excipient solution of aDC1 cell suspension consisting of a commercial ringer´s lactate solution.

Other: Commercial ringer´s lactate solution

aDC1immunization

ACTIVE COMPARATOR

The participants will be immunized with aDC1 unpulsed with HIV peptides.

Biological: Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides

aDC1 immunization with analytical treatment interruption of ART

EXPERIMENTAL

The participants will be immunized with aDC1 pulsed with HIV peptides.

Biological: Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides

Interventions

Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides BIOLOGICAL

Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides

aDC1immunization

Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides BIOLOGICAL

Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides

aDC1 immunization with analytical treatment interruption of ART

Commercial ringer´s lactate solution OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection confirmed according to the criteria of the Department of Chronic Diseases and Sexually Transmitted Infections of the Brazilian Health Ministry;
• Absence of the use of antineoplastic or corticosteroid therapies for a minimum period of six months prior to study entry;
• Absence of comorbidities considered uncontrolled by researchers;
• Viral load ≤ 40 copies/mL, stable (i.e., no \> 0.5 log) in the six months prior to the start of the study;
• Blood count of CD4 T lymphocytes ≥ 500 cells/μL, stable (i.e., \>25%) in the six months prior to the start of the study;
• Informed consent

You may not qualify if:

• Individuals without adequate venous access to the blood collection and apheresis procedure;
• Use of drugs or alcohol in a way that interferes with patients' ability to follow the study requirements;
• Pregnancy, breastfeeding or interest in becoming pregnant during the study period;
• Presence of any other condition that, in the evaluation of researchers is able to promote alteration of the immune system, as well as any disorders that could affect understanding in the process of informed consent.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Interventions

Heart Rate

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Alberto José DS Duarte, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto José DS Duarte, PhD

CONTACT

+55 (11) 3061-7499; adjsduar@usp.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: To avoid bias in evaluating the results, the research volunteer and the team that will perform the application of the vaccine product will be blind in the present study. The team responsible for coordinating the project will not be blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: Phase I, double-blind, randomized study with three parallel groups as follows: : G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 28, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)