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

HIV Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05786937
• Other study ID #: INHC031
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2023
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: University of Sao Paulo General Hospital
• Contact: Alberto José DS Duarte, PhD
• Phone: +55 (11) 3061-7499
• Email: adjsduar[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Vaccine
• Viremia

Intervention

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

Other:
• Commercial ringer´s lactate solution
Placebo

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events related to the study product	Number of participants with adverse events related to the study product	Six months
Primary	Plasma viral load setpoint after the intervention	Number of participants with changes in the plasma viral load setpoint after the intervention	Six months
Primary	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