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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
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies Pre-exposure Prophylaxis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 24, 2014
Last Updated
October 27, 2014
Sponsor
Leiden University Medical Center
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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

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One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding

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