One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding
Primary Purpose
Rabies Pre-exposure Prophylaxis
Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
rabies vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Rabies Pre-exposure Prophylaxis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Good health according to the investigator
- Willingness and ability to adhere to the study regimen
- Able to give informed consent
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Leiden University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
A - ID
B - ID
C - ID
D - IM
Arm Description
Intradermal administration. 20% dose in a single visit.
Intradermal administration. 40% dose in a single visit.
Intradermal administration. 60% dose in a single visit.
1x IM
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02276625
First Posted
October 24, 2014
Last Updated
October 27, 2014
Sponsor
Leiden University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02276625
Brief Title
One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding
Official Title
One-visit Multi-site Pre-exposure Intradermal Rabies Vaccination: Dose Finding in Healthy Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leiden University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies Pre-exposure Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A - ID
Arm Type
Experimental
Arm Description
Intradermal administration. 20% dose in a single visit.
Arm Title
B - ID
Arm Type
Experimental
Arm Description
Intradermal administration. 40% dose in a single visit.
Arm Title
C - ID
Arm Type
Experimental
Arm Description
Intradermal administration. 60% dose in a single visit.
Arm Title
D - IM
Arm Type
Active Comparator
Arm Description
1x IM
Intervention Type
Biological
Intervention Name(s)
rabies vaccine
Intervention Description
Compare ID administration to IM administration. 1 visit schedule.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Good health according to the investigator
Willingness and ability to adhere to the study regimen
Able to give informed consent
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emile Jonker, MD
Email
e.f.f.jonker@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Visser, M, PhD
Organizational Affiliation
LUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
South-Holland
ZIP/Postal Code
2333ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leo Visser, MD, PhD
Email
l.g.visser@lumc.nl
First Name & Middle Initial & Last Name & Degree
Emile Jonker, MD
First Name & Middle Initial & Last Name & Degree
Leo Visser, Professor, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding
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