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

University of Sao Paulo General Hospital

Status and phase: Not yet enrolling; Phase 1

Conditions: HIV Vaccine

Treatments: Other: Commercial ringer´s lactate solution; Biological: Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides; Biological: Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides

Study type: Interventional

Funder types: Other

Identifiers

NCT05786937

INHC031

Details and patient eligibility

About

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.

Full description

Dendritic cell based immunotherapy is a potential tool to stimulate a specific immune response, as a complementary treatment for HIV-infected individuals using ART. Polarizing DCs are capable to produce high levels of IL-12p70 and induce a strong cytotoxic response that is very useful in viral infections. In this context, we propose to study aDC1 pulsed with relevant HIV peptides for treatment of 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. Autologous PBMCs will be collected for baseline parameters and vaccine will be inoculated in 3 doses (with 4 week interval). Three weeks after 3th vaccine inoculation, patients will be followed for 6 months and blood and biopsis samples will be collected for different parameters measurement as immune activation, immunogenicity, humoral response, mucosal cellular immunity and virologic profile and viral reservoir analysis.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Commercial ringer´s lactate solution

aDC1immunization

Active Comparator group

Description:

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

Treatment:

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

aDC1 immunization with analytical treatment interruption of ART

Experimental group

Description:

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

Treatment:

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