- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02390466
Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1
June 16, 2016 updated by: InnaVirVax
Multicentre, Open-label, Phase I/IIa Clinical Study of an Immunoprotective Therapeutic Vaccine Candidate (VAC-3S) in Human Immunodeficiency Virus Type 1 (HIV-1) Chronically Infected Patients Virologically Controlled on Antiretroviral Therapy (ART) Who Rose an Immune Response to VAC-3S During IVVAC-3S/P1
The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Paris, France, 75013
- Hopital Pitie Salpetriere
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Paris, France, 75014
- Hôpital Cochin Saint Vincent de Paul
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HIV-1 infected patient,
- Age between 18 and 60 years,
- ART (Anti Retroviral Therapy) initiation ≥ 1 year ago,
- Plasma HIV RNA ≤ 200 copies/ml in the past 12 months,
- Plasma HIV RNA ≤ 50 copies/ml at the screening visit,
- CD4+ T cell count ≥ 200 cells/mm3,
- Nadir CD4+ T cell count ≥ 100 cells/mm3,
- Contraception in women with child-bearing potential,
- A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial,
- Per protocol subject having completed the IVVAC-3S/P1 study.
- Patient affiliated to a social security system,
- Patient who has understood the protocol design and provided a signed written informed consent form,
- Patient who is willing and capable of cooperating to the extent and degree required by the protocol,
- Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site.
Exclusion Criteria:
- Administration of VAC-3S in the past year,
- Chronic active liver disease,
- History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
- Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,
- Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
- Ongoing pregnancy,
- Breastfeeding women,
- Patient with known sensitivities to investigational drug (see please the CIB),
- History of allergy to any vaccine,
- Any severe chronic condition that would interfere with the study,
- History of auto-immune disease,
- Organ transplant,
- Splenectomy,
- Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
- Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).
- Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
- Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VAC-3S
32µg/ml corresponding to 16µg/vaccination
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Administered via intra-muscular injection in the arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who tolerated 3 vaccinations with VAC-3S 16µg/mL at 4-weeks interval determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Time Frame: From Day 0 to week 16
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From Day 0 to week 16
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who tolerated a fourth booster injection of VAC-3S 16µg/mL determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Time Frame: From Week 16 to Week 48
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From Week 16 to Week 48
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Anti-3S antibody titers
Time Frame: From Day 0 to Week 48
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From Day 0 to Week 48
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Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation
Time Frame: From Day 0 to Week 48
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From Day 0 to Week 48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
April 1, 2017
Study Registration Dates
First Submitted
January 30, 2015
First Submitted That Met QC Criteria
March 10, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Estimate)
June 17, 2016
Last Update Submitted That Met QC Criteria
June 16, 2016
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- IVVAC-3S/P2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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