Back to resultsTherapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected Individuals
Primary Purpose
HIV Vaccine
Status
Not yet recruiting
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides
Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides
Commercial ringer´s lactate solution
Sponsored by
About this trial
This is an interventional treatment trial for HIV Vaccine focused on measuring HIV, Immunotherapy, Polarizing dendritic cells
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.
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina da USP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Placebo
aDC1immunization
aDC1 immunization with analytical treatment interruption of ART
Arm Description
The participants will receive a placebo, which is the excipient solution of aDC1 cell suspension consisting of a commercial ringer´s lactate solution.
The participants will be immunized with aDC1 unpulsed with HIV peptides.
The participants will be immunized with aDC1 pulsed with HIV peptides.
Outcomes
Primary Outcome Measures
Adverse events related to the study product
Number of participants with adverse events related to the study product
Plasma viral load setpoint after the intervention
Number of participants with changes in the plasma viral load setpoint after the intervention
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05786937
First Posted
March 14, 2023
Last Updated
March 14, 2023
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05786937
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Vaccine
Keywords
HIV, Immunotherapy, Polarizing dendritic cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The participants will receive a placebo, which is the excipient solution of aDC1 cell suspension consisting of a commercial ringer´s lactate solution.
Arm Title
aDC1immunization
Arm Type
Active Comparator
Arm Description
The participants will be immunized with aDC1 unpulsed with HIV peptides.
Arm Title
aDC1 immunization with analytical treatment interruption of ART
Arm Type
Experimental
Arm Description
The participants will be immunized with aDC1 pulsed with HIV peptides.
Intervention Type
Biological
Intervention Name(s)
Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides
Intervention Description
Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides
Intervention Type
Biological
Intervention Name(s)
Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides
Intervention Description
Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides
Intervention Type
Other
Intervention Name(s)
Commercial ringer´s lactate solution
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Adverse events related to the study product
Description
Number of participants with adverse events related to the study product
Time Frame
Six months
Title
Plasma viral load setpoint after the intervention
Description
Number of participants with changes in the plasma viral load setpoint after the intervention
Time Frame
Six months
Title
Setpoint of CD4+ T lymphocyte count after the intervention
Description
Number of participants with changes in the setpoint of CD4+ T lymphocyte count after the intervention
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto José DS Duarte, PhD
Phone
+55 (11) 3061-7499
Email
adjsduar@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto José DS Duarte, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected Individuals
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