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

Rabies Pre-exposure Prophylaxis Clinical Trial

Official title:

One-visit Multi-site Pre-exposure Intradermal Rabies Vaccination: Dose Finding in Healthy Adults.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02276625
• Other study ID #: R5
• Status: Recruiting
• Phase: Phase 2
• First received: October 24, 2014
• Last updated: October 27, 2014
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2014
• Source: Leiden University Medical Center
• Contact: Emile Jonker, MD
• Email: e.f.f.jonker[@]lumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rabies
• Rabies Pre-exposure Prophylaxis

Intervention

Biological:
• rabies vaccine
Compare ID administration to IM administration. 1 visit schedule.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	South-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		1 year	No