HIVPhase 1/2NCT02390466
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
A Phase 1/2 study testing VAC-3S in people with HIV, run by InnaVirVax at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV
- What is being tested?
- VAC-3S
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2015to Apr 2017
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Pitié Salpêtrière
Paris, 75013
Hôpital Cochin Saint Vincent de Paul
Paris, 75014
About this study
Official title: 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.
- Conditions
- HIV
- Being tested
- VAC-3S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC-3SBiological
Administered via intra-muscular injection in the arm
| Study group | Role | What they receive |
|---|---|---|
| VAC-3S | Experimental | 32µg/ml corresponding to 16µg/vaccination Receives: Biological: VAC-3S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 0 to week 16
Secondary outcomes (3)
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.
Measured: From Week 16 to Week 48
Anti-3S antibody titers
Measured: From Day 0 to Week 48
Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation
Measured: From Day 0 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnaVirVax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raphaël Ho Tsong Fang, DVM PhD, Study director, InnaVirVax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390466
- Sponsor's protocol ID
- IVVAC-3S/P2
- Status last verified
- Oct 2015
- First submitted
- 30 Jan 2015
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02390466
- Acronym / sponsor ID
- IVVAC-3S/P2
- Conditions
- HIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- InnaVirVaxIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAC-3S | Experimental | Biological: VAC-3S32µg/ml corresponding to 16µg/vaccination |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (17 listed)
- 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,
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 |
|---|---|---|
| VAC-3SAdministered via intra-muscular injection in the arm | Biological | VAC-3S |
Primary outcome
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
3 secondary outcomes
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
Anti-3S antibody titers
Time frame: From Day 0 to Week 48
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
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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.
Raphaël Ho Tsong Fang, DVM PhD study director
InnaVirVax
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VAC-3S in people with HIV, run by InnaVirVax at 2 sites in France.
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 14 inclusion and 17 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 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 17 Jun 2016.