HIV VaccinePhase 1NCT05786937
Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected Individuals
A Phase 1 study testing Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides, Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides and Commercial ringer´s lactate solution in people with HIV Vaccine, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Vaccine
- What is being tested?
- Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides, Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides and Commercial ringer´s lactate solution
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2023to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 05403-000
About this study
Official title: Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After Antiretroviral Therapy Interruption in HIV Infected Individuals
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.
Read the 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.
- Conditions
- HIV Vaccine
- Being tested
- 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
- Keywords
- HIV, Immunotherapy, Polarizing dendritic cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptidesBiological
Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides
Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptidesBiological
Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides
Commercial ringer´s lactate solutionOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The participants will receive a placebo, which is the excipient solution of aDC1 cell suspension consisting of a commercial ringer´s lactate solution. Receives: Other: Commercial ringer´s lactate solution |
| aDC1immunization | Active comparator | The participants will be immunized with aDC1 unpulsed with HIV peptides. Receives: Biological: Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides |
| aDC1 immunization with analytical treatment interruption of ART | Experimental | The participants will be immunized with aDC1 pulsed with HIV peptides. Receives: Biological: Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to the study product
Number of participants with adverse events related to the study product
Measured: Six months
Plasma viral load setpoint after the intervention
Number of participants with changes in the plasma viral load setpoint after the intervention
Measured: Six months
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
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study startJun 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV VaccineStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto José da Silva Duarte, University of Sao Paulo General Hospital
- Investigators
- Alberto José DS Duarte, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786937
- Sponsor's protocol ID
- INHC031
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After Antiretroviral Therapy Interruption in HIV Infected Individuals
- ClinicalTrials.gov ID
- NCT05786937
- Acronym / sponsor ID
- INHC031
- Conditions
- HIV Vaccine
- Keywords
- HIV, Immunotherapy, Polarizing dendritic cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Commercial ringer´s lactate solutionThe participants will receive a placebo, which is the excipient solution of aDC1 cell suspension consisting of a commercial ringer´s lactate solution. |
| aDC1immunization | Active comparator | Biological: Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptidesThe participants will be immunized with aDC1 unpulsed with HIV peptides. |
| aDC1 immunization with analytical treatment interruption of ART | Experimental | Biological: Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptidesThe participants will be immunized with aDC1 pulsed with HIV peptides. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptidesAlpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides | Biological | aDC1immunization |
| Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptidesAlpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides | Biological | aDC1 immunization with analytical treatment interruption of ART |
| Commercial ringer´s lactate solutionPlacebo | Other | Placebo |
Primary outcome
Adverse events related to the study product
Time frame: Six months
Number of participants with adverse events related to the study product
Plasma viral load setpoint after the intervention
Time frame: 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
Time frame: Six months
Number of participants with changes in the setpoint of CD4+ T lymphocyte count after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto José DS Duarte, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides, Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides and Commercial ringer´s lactate solution in people with HIV Vaccine, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto José DS Duarte, PhD (+55 (11) 3061-7499, adjsduar@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to the study product (time frame: Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.