HIV Vaccine
Conditions
Keywords
HIV, Immunotherapy, Polarizing dendritic cells
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.
Interventions
BIOLOGICALAlpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides
Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides
BIOLOGICALAlpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides
Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides
OTHERCommercial ringer´s lactate solution
Placebo
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events related to the study product | Six months | Number of participants with adverse events related to the study product |
| Plasma viral load setpoint after the intervention | Six months | Number of participants with changes in the plasma viral load setpoint after the intervention |
| Setpoint of CD4+ T lymphocyte count after the intervention | Six months | Number of participants with changes in the setpoint of CD4+ T lymphocyte count after the intervention |
Countries
Brazil
Contacts
Primary ContactAlberto José DS Duarte, PhD
Outcome results
None listed