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

NCT ID: NCT02276625

Last Updated: 2014-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Rabies Pre-exposure Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A - ID

Intradermal administration. 20% dose in a single visit.

Group Type EXPERIMENTAL

rabies vaccine

Intervention Type BIOLOGICAL

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B - ID

Intradermal administration. 40% dose in a single visit.

Group Type EXPERIMENTAL

rabies vaccine

Intervention Type BIOLOGICAL

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C - ID

Intradermal administration. 60% dose in a single visit.

Group Type EXPERIMENTAL

rabies vaccine

Intervention Type BIOLOGICAL

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D - IM

1x IM

Group Type ACTIVE_COMPARATOR

rabies vaccine

Intervention Type BIOLOGICAL

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Interventions

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rabies vaccine

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Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leo Visser, M, PhD

Role: PRINCIPAL_INVESTIGATOR

LUMC

Locations

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Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Emile Jonker, MD

Role: CONTACT

Facility Contacts

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Leo Visser, MD, PhD

Role: primary

Other Identifiers

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R5

Identifier Type: -

Identifier Source: org_study_id

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