Hepatitis BPhase 1POC_VAX-IDNCT02186977
Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
A Phase 1 study testing VAX-ID, 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) and 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) in people with Hepatitis B, run by Novosanis NV at 1 site in Belgium.
Trial summary
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a newly developed intradermal injection device… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- VAX-ID, 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) and 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2016to Dec 2016
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults, checked anamnestically (based on medical history) at entry of the study
- 18-35 years
- vaccination status: fully vaccinated against hepatitis B at least 5 years ago, with proof of vaccine response (to avoid non-response among the subjects). Subjects has to ask for a document of this proof at the service occupational medicine of the University of Antwerp.
- capable of understanding, reading and writing Dutch
Who cannot join
- other vaccination(s) 4 weeks before study onset
- pregnancy and lactation (women will be questioned during anamnesis)
- plan to have other vaccination during the study period
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
Wilrijk, Antwerp, 2610
About this study
Official title: Proof Of Concept Study: Immunogenicity and Safety of Hepatitis B Injection in the Dermis in Healthy Volunteers Using an Intradermal Injection Device (VAX-ID)
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a newly developed intradermal injection device VAX-ID, compared to intramuscular and intradermal (Mantoux technique) injection.
- Conditions
- Hepatitis B
- Being tested
- VAX-ID, 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD), 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
- Keywords
- immunogenicity, safety, proof of concept
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAX-IDDevice
Also called INTRADERMAL
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)Drug
Also called INTRAMUSCULAR
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)Drug
Also called MANTOUX_INTRADERMAL
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular group | Active comparator | These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region. Receives: Drug: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) |
| Intradermal group (Mantoux) | Experimental | These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected. Receives: Drug: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) |
| Intradermal group (VAX-ID) A | Experimental | These subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. Receives: Device: VAX-ID |
| Intradermal group (VAX-ID) B | Experimental | These subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. Receives: Device: VAX-ID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects
Measured: after 14 days
Secondary outcomes (1)
Safety: solicited local and systemic reactions, unsolicited adverse events and Serious Adverse Events occurrence, intensity and relationship to vaccination of all Adverse Events reported during the 14-day follow-up period after the challenge dose
Measured: during 14 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novosanis NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Van Damme, Prof, Principal investigator, Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186977
- Sponsor's protocol ID
- CP140465_2014_001_v5
- Acronym
- POC_VAX-ID
- Status last verified
- Mar 2017
- First submitted
- 8 Jul 2014
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof Of Concept Study: Immunogenicity and Safety of Hepatitis B Injection in the Dermis in Healthy Volunteers Using an Intradermal Injection Device (VAX-ID)
- ClinicalTrials.gov ID
- NCT02186977
- Acronym / sponsor ID
- POC_VAX-ID / CP140465_2014_001_v5
- Conditions
- Hepatitis B
- Keywords
- immunogenicity, safety, proof of concept
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novosanis NVIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jul 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.
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a newly developed intradermal injection device VAX-ID, compared to intramuscular and intradermal (Mantoux technique) injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intramuscular group | Active comparator | Drug: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region. |
| Intradermal group (Mantoux) | Experimental | Drug: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected. |
| Intradermal group (VAX-ID) A | Experimental | Device: VAX-IDThese subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. |
| Intradermal group (VAX-ID) B | Experimental | Device: VAX-IDThese subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy adults, checked anamnestically (based on medical history) at entry of the study
- 18-35 years
- vaccination status: fully vaccinated against hepatitis B at least 5 years ago, with proof of vaccine response (to avoid non-response among the subjects). Subjects has to ask for a document of this proof at the service occupational medicine of the University of Antwerp.
- capable of understanding, reading and writing Dutch
Key exclusion criteria (3 listed)
- other vaccination(s) 4 weeks before study onset
- pregnancy and lactation (women will be questioned during anamnesis)
- plan to have other vaccination during the study period
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 |
|---|---|---|
| VAX-IDAlso: INTRADERMAL0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection | Device | Intradermal group (VAX-ID) A, Intradermal group (VAX-ID) B |
| 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)Also: INTRAMUSCULAR1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) | Drug | Intramuscular group |
| 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)Also: MANTOUX_INTRADERMAL0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection | Drug | Intradermal group (Mantoux) |
Primary outcome
Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects
Time frame: after 14 days
1 secondary outcome
Safety: solicited local and systemic reactions, unsolicited adverse events and Serious Adverse Events occurrence, intensity and relationship to vaccination of all Adverse Events reported during the 14-day follow-up period after the challenge dose
Time frame: during 14 days post vaccination
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 28 Mar 2017.
- 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.
Pierre Van Damme, Prof principal investigator
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
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 VAX-ID, 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) and 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) in people with Hepatitis B, run by Novosanis NV at 1 site in Belgium.
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 4 inclusion and 3 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 28 Mar 2017. 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 Belgium. 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 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?
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?
Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects (time frame: after 14 days). 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 2017.