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

October 27, 2014 updated by: Leiden University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • South-Holland
      • Leiden, South-Holland, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center
        • Contact:
        • Sub-Investigator:
          • Emile Jonker, MD
        • Principal Investigator:
          • Leo Visser, Professor, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A - ID
Intradermal administration. 20% dose in a single visit.
Biological: rabies vaccine
Compare ID administration to IM administration. 1 visit schedule.
Experimental: B - ID
Intradermal administration. 40% dose in a single visit.
Biological: rabies vaccine
Compare ID administration to IM administration. 1 visit schedule.
Experimental: C - ID
Intradermal administration. 60% dose in a single visit.
Biological: rabies vaccine
Compare ID administration to IM administration. 1 visit schedule.
Active Comparator: D - IM
1x IM
Biological: rabies vaccine
Compare ID administration to IM administration. 1 visit schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Investigators

  • Principal Investigator: Leo Visser, M, PhD, LUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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