HIVPhase 2NCT02041247
Assessment of VAC-3S Therapeutic Properties When Combined With Standard ART in the Course of HIV-1 Infection
A Phase 2 study testing VAC-3S in people with HIV, run by InnaVirVax at 12 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the protective effect 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jan 2014to Nov 2016
- Phase
- Phase 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
- Documented HIV-1 infection,
- Adults > 18 and < 60 years of age,
- Able and willing to comply with the protocol, including availability for all scheduled study visits,
- Provided a signed written informed consent,
- Meets study screening physical, medical history and laboratory assessments (defined below),
- On stable antiretroviral therapy that is consistent with the current standard of care for at least 12 months prior to study screening,
Show all 13Show fewer
- Plasma HIV RNA < 50 cps/mL during the previous 12 months,
- CD4+ T cell count at screening > 200 and < 500 cells/mm3,
- Adequate hematology, biochemistry, and metabolic blood tests defined as being less than grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1), except for the numeration of CD4 and for the numeration of lymphocytes,
- Adequate hepatic and renal function defined as being less than Grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1),
- Female patients of childbearing age with one documented negative blood pregnancy tests between Screening and Visit 1/Month 0; Female patient of childbearing potential must be receiving two forms of effective contraception and must be willing to use them throughout the study duration. These include oral, transdermal, systemic or implant contraception birth control, intra-uterine devices (IUD), abstinence and double barrier method such as diaphragm with spermicidal gel or other recommended double barrier method,
- Affiliated with the National Medical Insurance System,
- Believed by investigator to be able and willing to comply with the requirements of the study protocol and will be available for all scheduled visits at the study site.
Who cannot join
- Not meeting all of the inclusion criteria listed above,
- Administration of any investigational drug or device within 28 days prior to screening,
- Prior history of an AIDS-defining event in the past 5 years,
- Active co-infection with either Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any other active viral hepatitis co-infection,
- Any acute or clinically significant infections within the past month,
- Known allergy or intolerance to components of VAC-3S as documented through medical records or via patient interview,
Show all 15Show fewer
- Chronic active liver disease as documented by any of the following laboratory assessments: ultrasound, clinical assessment, liver biopsy or equivalent non-invasive methods,
- Receipt of any known vaccinations within the past 1 month prior to screening,
- Receipt of any agent in the past 12 months that exerts a known immunological effect (e.g. includes but not limited to IL-2, IL-7, growth hormone…),
- Patients with Insulin Dependent Diabetes Mellitus, patients receiving anti-diabetic treatment, anticoagulants (excluding daily "baby-dose" aspirin) or daily NSAIDs within one week of study enrollment,
- Receipt of any contraindicated medications listed in Appendix 23.2,
- History of or active auto-immune disease,
- Acute or chronic psychiatric conditions which in the opinion of the investigator would need continual psychological support and/or medications incompatible with study participation,
- 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 safety of the patient or the ability to properly administer the study.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
France9 sites
Hôpital Sud Francilien
Corbeil-Essonne, 91106
Hôpital de la Croix Rousse
Lyon, 69317
Hôpital Gui de Chauliac
Montpellier, 34295
Hôpital Saint-Antoine
Paris, 75012
Hôpital Pitié Salpêtrière
Paris, 75013
Hôpital Cochin Saint Vincent de Paul
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Bichat - Claude Bernard
Paris, 75018
Hôpital Tenon
Paris, 75020
About this study
Official title: Assessment of VAC-3S Therapeutic Properties When Combined With Standard Antiretroviral Therapy (ART) in the Course of HIV-1 Infection. A European, Randomized, Double Blind Placebo-controlled Phase II Study
The purpose of this study is to evaluate the protective effect 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
VAC-3S is administered via intra-muscular route in the arm.
| Study group | Role | What they receive |
|---|---|---|
| VAC-3S 16µg/administration | Active comparator | VAC-3S 16µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. Receives: Biological: VAC-3S |
| VAC-3S Placebo | Placebo comparator | VAC-3S placebo administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. Receives: Biological: VAC-3S |
| VAC-3S 32 µg/administration | Active comparator | VAC-3S 32µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. Receives: Biological: VAC-3S |
| VAC-3S 64 µg/administration | Active comparator | VAC-3S 64µg/ml administered every 4 weeks for 3 months without maintenance vaccination. Receives: Biological: VAC-3S |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-3S antibodies titer
Measured: From D0 to week 24
Secondary outcomes (5)
tolerance to 6 vaccinations of VAC-3S
safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) adverse events (AEs) grading table.Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load, CD4 and CD8 counts)
Measured: From D0 to week 72
blood inflammatory marker concentrations
Inflammatory markers include: Highly sensitive C-reactive protein (hsCRP), Highly sensitive Recombinant human interleukin 6 (hsIL-6), Soluble CD14 (sCD14), Soluble CD163 (sCD163), D-dimer, Interferon (IFN)-gamma inducible protein 10 (IP-10), Tumor necrosis factor receptor 1 (sTNFR1) and 2 (sTNFR2), Immunoglobulin G (IgG),
Measured: From D0 to week 72
immunogenic characteristics of VAC-3S
anti-3S antibody titers and determination of anti-3S antibody isotypes and avidity
Measured: From D0 to week 72
lymphocyte phenotype markers
Phenotype markers include: Nkp44L expression on the surface of CD4+ T lymphocytes, phenotypic markers of of lymphocyte differentiation and activation
Measured: From D0 to week 72
secondary virological effects
3S gp41 sequences and proviral HIV reservoir
Measured: From D0 to week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionNov 2016 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnaVirVax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raphael Ho Tsong Fang, DVM PhD, Study director, InnaVirVax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041247
- Sponsor's protocol ID
- IPROTECT1
- Other IDs
- 2013-002735-23
- Status last verified
- Jun 2016
- First submitted
- 27 Nov 2013
- 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
- Assessment of VAC-3S Therapeutic Properties When Combined With Standard Antiretroviral Therapy (ART) in the Course of HIV-1 Infection. A European, Randomized, Double Blind Placebo-controlled Phase II Study
- ClinicalTrials.gov ID
- NCT02041247
- Acronym / sponsor ID
- IPROTECT1
- Conditions
- HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- InnaVirVaxIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 22 Jan 2014 (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 protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VAC-3S 16µg/administration | Active comparator | Biological: VAC-3SVAC-3S 16µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. |
| VAC-3S Placebo | Placebo comparator | Biological: VAC-3SVAC-3S placebo administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. |
| VAC-3S 32 µg/administration | Active comparator | Biological: VAC-3SVAC-3S 32µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. |
| VAC-3S 64 µg/administration | Active comparator | Biological: VAC-3SVAC-3S 64µg/ml administered every 4 weeks for 3 months without maintenance vaccination. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Documented HIV-1 infection,
- Adults > 18 and < 60 years of age,
- Able and willing to comply with the protocol, including availability for all scheduled study visits,
- Provided a signed written informed consent,
- Meets study screening physical, medical history and laboratory assessments (defined below),
Key exclusion criteria (15 listed)
- Not meeting all of the inclusion criteria listed above,
- Administration of any investigational drug or device within 28 days prior to screening,
- Prior history of an AIDS-defining event in the past 5 years,
- Active co-infection with either Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any other active viral hepatitis co-infection,
- Any acute or clinically significant infections within 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-3SVAC-3S is administered via intra-muscular route in the arm. | Biological | VAC-3S 16µg/administration, VAC-3S 32 µg/administration, VAC-3S 64 µg/administration, VAC-3S Placebo |
Primary outcome
anti-3S antibodies titer
Time frame: From D0 to week 24
5 secondary outcomes
tolerance to 6 vaccinations of VAC-3S
Time frame: From D0 to week 72
blood inflammatory marker concentrations
Time frame: From D0 to week 72
immunogenic characteristics of VAC-3S
Time frame: From D0 to week 72
lymphocyte phenotype markers
Time frame: From D0 to week 72
secondary virological effects
Time frame: From D0 to week 72
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.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Raphael Ho Tsong Fang, DVM PhD study director
InnaVirVax
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAC-3S in people with HIV, run by InnaVirVax at 12 sites in 3 countries.
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 13 inclusion and 15 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 12 sites in France, Germany, Spain. 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 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?
anti-3S antibodies titer (time frame: From D0 to week 24). 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.