Rabies Pre-exposure ProphylaxisPhase 2NCT02276625
One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding
A Phase 2 study testing rabies vaccine in people with Rabies Pre-exposure Prophylaxis, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Pre-exposure Prophylaxis
- What is being tested?
- rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years
- Good health according to the investigator
- Willingness and ability to adhere to the study regimen
- Able to give informed consent
Who cannot join
- Known or suspected previous vaccination against rabies
- Known or suspected allergy against any of the vaccine components
- History of unusual or severe reactions to any previous vaccination
- Immunocompromized state due to illness or medication
- Administration of plasma or blood products three months prior to inclusion in the study
- (hydroxy)chloroquine or mefloquine use
Show all 10Show fewer
- History of any neurological disorder including epilepsy or febrile seizures
- Pregnancy or breastfeeding
- Any current infectious disease other than seasonal cold
- Bleeding disorders or use of anticoagulants
Trial locations and contacts
1 site in 1 country.
Emile Jonker, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Leo Visser, MD, PhD, l.g.visser@lumc.nl
Emile Jonker, MD
About this study
Official title: One-visit Multi-site Pre-exposure Intradermal Rabies Vaccination: Dose Finding in Healthy Adults.
To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.
- Conditions
- Rabies Pre-exposure Prophylaxis
- Being tested
- rabies vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabies vaccineBiological
Compare ID administration to IM administration. 1 visit schedule.
| Study group | Role | What they receive |
|---|---|---|
| A - ID | Experimental | Intradermal administration. 20% dose in a single visit. Receives: Biological: rabies vaccine |
| B - ID | Experimental | Intradermal administration. 40% dose in a single visit. Receives: Biological: rabies vaccine |
| C - ID | Experimental | Intradermal administration. 60% dose in a single visit. Receives: Biological: rabies vaccine |
| D - IM | Active comparator | 1x IM Receives: Biological: rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies Pre-exposure ProphylaxisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leo Visser, M, PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276625
- Sponsor's protocol ID
- R5
- Status last verified
- Oct 2014
- First submitted
- 24 Oct 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-visit Multi-site Pre-exposure Intradermal Rabies Vaccination: Dose Finding in Healthy Adults.
- ClinicalTrials.gov ID
- NCT02276625
- Acronym / sponsor ID
- R5
- Conditions
- Rabies Pre-exposure Prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 28 Oct 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.
To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - ID | Experimental | Biological: rabies vaccineIntradermal administration. 20% dose in a single visit. |
| B - ID | Experimental | Biological: rabies vaccineIntradermal administration. 40% dose in a single visit. |
| C - ID | Experimental | Biological: rabies vaccineIntradermal administration. 60% dose in a single visit. |
| D - IM | Active comparator | Biological: rabies vaccine1x IM |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Good health according to the investigator
- Willingness and ability to adhere to the study regimen
- Able to give informed consent
Key exclusion criteria (10 listed)
- Known or suspected previous vaccination against rabies
- Known or suspected allergy against any of the vaccine components
- History of unusual or severe reactions to any previous vaccination
- Immunocompromized state due to illness or medication
- Administration of plasma or blood products three months prior to inclusion in the study
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 |
|---|---|---|
| rabies vaccineCompare ID administration to IM administration. 1 visit schedule. | Biological | A - ID, B - ID, C - ID, D - IM |
Primary outcome
Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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Safety and Immunogenicity of ID vs IM Rabies Vaccine
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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.
Emile Jonker, MD contact
Leo Visser, M, PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rabies vaccine in people with Rabies Pre-exposure Prophylaxis, run by Leiden University Medical Center at 1 site in Netherlands.
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 10 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 28 Oct 2014. 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 Netherlands. 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 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?
Contact Emile Jonker, MD (e.f.f.jonker@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario) (time frame: 1 year). 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 Oct 2014.