HIV-1 InfectionPhase 1/2NCT01549119
Phase I/IIa Dose-escalation Clinical Study of VAC-3S
A Phase 1/2 study testing VAC-3S in people with HIV-1 Infection, run by InnaVirVax at 2 sites in France.
Trial summary
The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV-1 Infection
- 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
- 33 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2012to Dec 2014
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-1 infected patient
- Age between 18 and 55 years
- ART (AntiRetroviral Therapy) initiation 1 year ago
- Plasma HIV RNA below 50 copies per ml on three sequential occasions including V-1 in the past 12 months
- CD4 T cell count above or equal to 200 cells per mm3,
- Nadir CD4 T cell count above or equal to 100 cells per mm3,
- Contraception in women with child-bearing potential
Who cannot join
- Any ART change within a month preceding screening.
- Chronic active liver disease, HIV-Hepatitis Coinfection.
- Immunotherapy in the past year, immunosuppressive treatment within the past month.
- History of auto-immune disease
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Pitie Salpetriere
Paris, 75013
CIC Cochin Pasteur
Paris, 75014
About this study
Official title: Multicentre, Randomized, Placebo-controlled, Double-blind, Phase I/IIa Dose-escalation Clinical Study of a Therapeutic Vaccine (VAC-3S) Intended to Confer Protection Against Immunopathological Effects of HIV-1 in Infected Patients
The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads.
- Conditions
- HIV-1 Infection
- Being tested
- VAC-3S, Placebo
- Keywords
- HIV-1, HIV, immunotherapy, active immunotherapy, vaccine, virulence, innate immunity, NK cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC-3SBiological
Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart
PlaceboBiological
Comparison with experimental vaccine
| Study group | Role | What they receive |
|---|---|---|
| Low dose VAC-3S | Experimental | Not described Receives: Biological: VAC-3S |
| Medium dose VAC-3S | Experimental | Not described Receives: Biological: VAC-3S |
| High dose VAC-3S | Experimental | Not described Receives: Biological: VAC-3S |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| Double-dose VAC-3S | Experimental | Not described Receives: Biological: VAC-3S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).
Measured: from D0 to week 24
Secondary outcomes (4)
Anti-3S antibody titers
Measured: from D0 to week 60
Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).
Measured: from week 24 to week 60
NKp44L expression on the surface of CD4+ T lymphocytes
Measured: from D0 to week 60
Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation.
Measured: from D0 to week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
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
- NCT01549119
- Sponsor's protocol ID
- IVVAC-3S/P1
- Status last verified
- Jan 2015
- First submitted
- 2 Mar 2012
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized, Placebo-controlled, Double-blind, Phase I/IIa Dose-escalation Clinical Study of a Therapeutic Vaccine (VAC-3S) Intended to Confer Protection Against Immunopathological Effects of HIV-1 in Infected Patients
- ClinicalTrials.gov ID
- NCT01549119
- Acronym / sponsor ID
- IVVAC-3S/P1
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1, HIV, immunotherapy, active immunotherapy, vaccine, virulence, innate immunity, NK cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- InnaVirVaxIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Mar 2012 (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 trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low dose VAC-3S | Experimental | Biological: VAC-3S |
| Medium dose VAC-3S | Experimental | Biological: VAC-3S |
| High dose VAC-3S | Experimental | Biological: VAC-3S |
| Placebo | Placebo comparator | Biological: Placebo |
| Double-dose VAC-3S | Experimental | Biological: VAC-3S |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- HIV-1 infected patient
- Age between 18 and 55 years
- ART (AntiRetroviral Therapy) initiation 1 year ago
- Plasma HIV RNA below 50 copies per ml on three sequential occasions including V-1 in the past 12 months
- CD4 T cell count above or equal to 200 cells per mm3,
Key exclusion criteria (4 listed)
- Any ART change within a month preceding screening.
- Chronic active liver disease, HIV-Hepatitis Coinfection.
- Immunotherapy in the past year, immunosuppressive treatment within the past month.
- History of auto-immune disease
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-3SComparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart | Biological | Double-dose VAC-3S, High dose VAC-3S, Low dose VAC-3S, Medium dose VAC-3S |
| PlaceboComparison with experimental vaccine | Biological | Placebo |
Primary outcome
Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Time frame: from D0 to week 24
Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).
4 secondary outcomes
Anti-3S antibody titers
Time frame: from D0 to week 60
Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Time frame: from week 24 to week 60
NKp44L expression on the surface of CD4+ T lymphocytes
Time frame: from D0 to week 60
Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation.
Time frame: from D0 to week 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Sponsor's websiteLink provided by the sponsor.
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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.
Raphael 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-1 Infection, 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 7 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: finished, as of the sponsor's last update on 2 Feb 2015. 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. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table. (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 2 Feb 2015.