Intradermal (ID) Vaccination DevicePhase 1NCT02538185
Intradermal Rabies Immunization Using NanoJect: A Comparative Study
A Phase 1 study testing NanoJect device (DebioJect™), Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus) and Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus) in people with Intradermal (ID) Vaccination Device, run by University of Lausanne Hospitals.
Trial summary
The study is planned as a single-center, randomized, double-blind placebo-controlled, comparative Phase I, first-in-man study to assess the safety and tolerability of the NanoJect™ device, and the immunogenicity of the rabies vaccine "Vaccin rabique Pasteur®" delivered with the NanoJect™ device by ID route. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intradermal (ID) Vaccination Device
- What is being tested?
- NanoJect device (DebioJect™), Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus) and Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Sep 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has completed the written informed consent process.
- Is male or female aged 18 years and 50 years.
- Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study.
- Agrees to avoid elective surgery for the duration of the study.
- For female subjects: agrees to avoid pregnancy through the duration of the study.
- Is in good general health, confirmed by medical history, physical examination and screening laboratory tests.
Who cannot join
- Oral body temperature 37.5 Celcius (C).
- History or evidence of rabies vaccination or rabies contact.
- Abnormal CBC (Complete Blood Count) laboratory values (>10% above Upper Limit of Normal (ULN) or >10% below Lower Limit of Normal (LLN)) and abnormal biochemistry values from blood collected at screening (>10% above ULN or >10% below LLN). Analysis can be repeated upon request of the clinician.
- History or evidence of autoimmune disease.
- History or evidence of any past, present, or future possible immunodeficiency state, including HIV 1 infection.
- History or evidence of chronic hepatitis, including presence of anti-hepatitis B core antibodies or anti-hepatitis C antibodies.Participation in any other investigational study during the study period.
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- Received immunoglobulin or blood products within 90 days prior to study visit 2.
- Received any investigational drug therapy or investigational vaccine within 180 days prior to study.
- Received any licensed vaccine within 45 days prior to study visit 2 (note: the use of licensed vaccines medically indicated during the study is permitted at any time).
- History or evidence of any treatment that, in the opinion of the investigator, may interfere with the vaccine response or compromise the safety of the subject.
- Received Chloroquin and/or Proguanil treatment within 420 days prior to study.
- Use of immunosuppressive drugs or anticoagulants.
- All female subjects: currently pregnant or lactating/nursing; positive screening urine pregnancy test; or positive urine pregnancy test on the day of any study vaccination
- History or evidence of allergic disease or reaction that, in the opinion of the investigator, may compromise the safety of the subject (Notably: allergy to active principle, excipients, polymyxin B, Streptomycin, Neomycin).
- History or evidence of dermatologic disease that, in the opinion of the investigator, may interfere with the assessment of injection site reactions.
- History or evidence of any other acute or chronic disease that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine or compromise the safety of the subject.
- Medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol.
- History or evidence of any brain disease that, in the opinion of the investigator, may interfere with the vaccine and compromise the safety of the subject.
- Abnormal urinalysis at the screening visit that, in the opinion of the investigator, is clinically significant.
- Skin coloration (skin color, tattoo, freckles) that, in the opinion of the investigator, could interfere with injection reactogenicity assessment.
- Body Mass Index (BMI)<= 18 and => 33 (weight/height2). Immediate need of rabies immunization.
About this study
The study is planned as a single-center, randomized, double-blind placebo-controlled, comparative Phase I, first-in-man study to assess the safety and tolerability of the NanoJect™ device, and the immunogenicity of the rabies vaccine "Vaccin rabique Pasteur®" delivered with the NanoJect™ device by ID route.
Read the detailed description
This study will enroll 66 volunteers randomly assigned to one of the three study arms. Each volunteer will receive three injections at each of three vaccination visits. Total study duration per volunteer is 2 months.
- Conditions
- Intradermal (ID) Vaccination Device
- Being tested
- NanoJect device (DebioJect™), Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus), Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus), Vaccin rabique Pasteur®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoJect device (DebioJect™)Device
The investigational device used in this study is the NanoJect™ device developed by Debiotech company.
Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus)Device
The comparator device used for standard ID injections is a classical syringe (1mL BD Luer-Lock™) with a 25G needle (Terumo® Neolus)
Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)Device
The comparator device used for standard IM injections is a classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)
Vaccin rabique Pasteur®Drug
PlaceboDrug
Sodium Chloride (NaCl) 0,9%; B. Braun
| Study group | Role | What they receive |
|---|---|---|
| Vaccine injected ID with classical syringe | Placebo comparator | Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL);
Left forearm, ID with classical syringe filled with vaccine (0.1mL);
Non-dominant deltoid, Intramuscular (IM) with classical syringe filled with placebo (0.5mL). Receives: Device: NanoJect device (DebioJect™); Device: Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus); Device: Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus); Drug: Vaccin rabique Pasteur®; Drug: Placebo |
| Vaccine injected ID with NanoJect device (DebioJect™) | Active comparator | Right forearm, ID with NanoJect device (DebioJect™) filled with vaccine (0.1mL);
Left forearm, ID with classical syringe filled with placebo (0.1mL);
Non-dominant deltoid, IM with classical syringe filled with placebo (0.5mL). Receives: Device: NanoJect device (DebioJect™); Device: Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus); Device: Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus); Drug: Vaccin rabique Pasteur®; Drug: Placebo |
| Vaccine injected IM with classical syringe | Placebo comparator | Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL);
Left forearm, ID with classical syringe filled with placebo (0.1mL);
Non-dominant deltoid, IM with classical syringe filled with vaccine (0.5mL). Receives: Device: NanoJect device (DebioJect™); Device: Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus); Device: Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus); Drug: Vaccin rabique Pasteur®; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events as a Measure of Safety and Tolerability
Measured: At the end of the study, at Day 56 (visit 5).
Pain Scores at needle insertion and at product injection as measured by the Visual Analog Scale
Measured: At each product injection: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4).
Pain following product injection as a Measure of Safety and Tolerability
Measured: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
Redness following product injection as a Measure of Safety and Tolerability
Measured: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
Pruritus following product injection as a Measure of Safety and Tolerability
Measured: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
Secondary outcomes (1)
Titers of Immunoglobulin G (IgG) anti-rabies antibodies analyzed by Rapid Fluorescent Focus Inhibition Test (RFFIT) as a measure of Immunogenicity
Measured: Change between baseline and last study visit: Day 56 (visit 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradermal (ID) Vaccination DeviceStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Pantaleo, University of Lausanne Hospitals
- Investigators
- Giuseppe Pantaleo, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538185
- Sponsor's protocol ID
- VIC-NANO-001
- Status last verified
- Mar 2020
- First submitted
- 8 Jul 2015
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradermal Rabies Immunization Using NanoJect: A Comparative Study
- ClinicalTrials.gov ID
- NCT02538185
- Acronym / sponsor ID
- VIC-NANO-001
- Conditions
- Intradermal (ID) Vaccination Device
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Sep 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 study is planned as a single-center, randomized, double-blind placebo-controlled, comparative Phase I, first-in-man study to assess the safety and tolerability of the NanoJect™ device, and the immunogenicity of the rabies vaccine "Vaccin rabique Pasteur®" delivered with the NanoJect™ device by ID route.
Detailed description
This study will enroll 66 volunteers randomly assigned to one of the three study arms. Each volunteer will receive three injections at each of three vaccination visits. Total study duration per volunteer is 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccine injected ID with classical syringe | Placebo comparator | Device: NanoJect device (DebioJect™), Device: Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus), Device: Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus), Drug: Vaccin rabique Pasteur®, Drug: PlaceboRight forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL); Left forearm, ID with classical syringe filled with vaccine (0.1mL); Non-dominant deltoid, Intramuscular (IM) with classical syringe filled with placebo (0.5mL). |
| Vaccine injected ID with NanoJect device (DebioJect™) | Active comparator | Device: NanoJect device (DebioJect™), Device: Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus), Device: Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus), Drug: Vaccin rabique Pasteur®, Drug: PlaceboRight forearm, ID with NanoJect device (DebioJect™) filled with vaccine (0.1mL); Left forearm, ID with classical syringe filled with placebo (0.1mL); Non-dominant deltoid, IM with classical syringe filled with placebo (0.5mL). |
| Vaccine injected IM with classical syringe | Placebo comparator | Device: NanoJect device (DebioJect™), Device: Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus), Device: Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus), Drug: Vaccin rabique Pasteur®, Drug: PlaceboRight forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL); Left forearm, ID with classical syringe filled with placebo (0.1mL); Non-dominant deltoid, IM with classical syringe filled with vaccine (0.5mL). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Has completed the written informed consent process.
- Is male or female aged 18 years and 50 years.
- Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study.
- Agrees to avoid elective surgery for the duration of the study.
- For female subjects: agrees to avoid pregnancy through the duration of the study.
Key exclusion criteria (21 listed)
- Oral body temperature 37.5 Celcius (C).
- History or evidence of rabies vaccination or rabies contact.
- Abnormal CBC (Complete Blood Count) laboratory values (>10% above Upper Limit of Normal (ULN) or >10% below Lower Limit of Normal (LLN)) and abnormal biochemistry values from blood collected at screening (>10% above ULN or >10% below LLN). Analysis can be repeated upon request of the clinician.
- History or evidence of autoimmune disease.
- History or evidence of any past, present, or future possible immunodeficiency state, including HIV 1 infection.
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 |
|---|---|---|
| NanoJect device (DebioJect™)The investigational device used in this study is the NanoJect™ device developed by Debiotech company. | Device | Vaccine injected ID with NanoJect device (DebioJect™), Vaccine injected ID with classical syringe, Vaccine injected IM with classical syringe |
| Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus)The comparator device used for standard ID injections is a classical syringe (1mL BD Luer-Lock™) with a 25G needle (Terumo® Neolus) | Device | Vaccine injected ID with NanoJect device (DebioJect™), Vaccine injected ID with classical syringe, Vaccine injected IM with classical syringe |
| Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)The comparator device used for standard IM injections is a classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus) | Device | Vaccine injected ID with NanoJect device (DebioJect™), Vaccine injected ID with classical syringe, Vaccine injected IM with classical syringe |
| Vaccin rabique Pasteur® | Drug | Vaccine injected ID with NanoJect device (DebioJect™), Vaccine injected ID with classical syringe, Vaccine injected IM with classical syringe |
| PlaceboSodium Chloride (NaCl) 0,9%; B. Braun | Drug | Vaccine injected ID with NanoJect device (DebioJect™), Vaccine injected ID with classical syringe, Vaccine injected IM with classical syringe |
Primary outcome
Number of Adverse Events as a Measure of Safety and Tolerability
Time frame: At the end of the study, at Day 56 (visit 5).
Pain Scores at needle insertion and at product injection as measured by the Visual Analog Scale
Time frame: At each product injection: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4).
Pain following product injection as a Measure of Safety and Tolerability
Time frame: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
Redness following product injection as a Measure of Safety and Tolerability
Time frame: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
Pruritus following product injection as a Measure of Safety and Tolerability
Time frame: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
1 secondary outcome
Titers of Immunoglobulin G (IgG) anti-rabies antibodies analyzed by Rapid Fluorescent Focus Inhibition Test (RFFIT) as a measure of Immunogenicity
Time frame: Change between baseline and last study visit: Day 56 (visit 5).
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 26 Mar 2020.
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.
Giuseppe Pantaleo principal investigator
CHUV
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NanoJect device (DebioJect™), Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus) and Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus) in people with Intradermal (ID) Vaccination Device, run by University of Lausanne Hospitals.
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 6 inclusion and 21 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Number of Adverse Events as a Measure of Safety and Tolerability (time frame: At the end of the study, at Day 56 (visit 5).). The study lists 5 primary outcomes in all. 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 26 Mar 2020; AzTrials last refreshed its copy on 27 Oct 2026.