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

Leiden University Medical Center (LUMC)

Status and phase: Unknown; Phase 2

Conditions: Rabies Pre-exposure Prophylaxis

Treatments: Biological: rabies vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02276625

R5

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 4 patient groups

A - ID

Experimental group

Description:

Intradermal administration. 20% dose in a single visit.

Treatment:

Biological: rabies vaccine

B - ID

Experimental group

Description:

Intradermal administration. 40% dose in a single visit.

Treatment:

Biological: rabies vaccine

C - ID

Experimental group

Description:

Intradermal administration. 60% dose in a single visit.

Treatment:

Biological: rabies vaccine

D - IM

Active Comparator group

Description:

1x IM

Treatment:

Biological: rabies vaccine