Clinical trial NCT05786937: Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected Individuals
Official title: Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After Antiretroviral Therapy Interruption in HIV Infected Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Vaccine
Keywords: HIV
Immunotherapy
Polarizing dendritic cells
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events related to the study product
timeFrame: Six months
measure: Plasma viral load setpoint after the intervention
timeFrame: Six months
measure: Setpoint of CD4+ T lymphocyte count after the intervention
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
Study officials:
affiliation: University of Sao Paulo
name: Alberto José DS Duarte, PhD
role: PRINCIPAL_INVESTIGATOR
References: