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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276625
Recruitment Status : Unknown
Verified October 2014 by Leiden University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 28, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Leiden University Medical Center

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.

Condition or disease Intervention/treatment Phase
Rabies Pre-exposure Prophylaxis Biological: rabies vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: One-visit Multi-site Pre-exposure Intradermal Rabies Vaccination: Dose Finding in Healthy Adults.
Study Start Date : October 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

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.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276625


Contacts
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Contact: Emile Jonker, MD e.f.f.jonker@lumc.nl

Locations
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Netherlands
Leiden University Medical Center Recruiting
Leiden, South-Holland, Netherlands, 2333ZA
Contact: Leo Visser, MD, PhD       l.g.visser@lumc.nl   
Sub-Investigator: Emile Jonker, MD         
Principal Investigator: Leo Visser, Professor, MD, PhD         
Sponsors and Collaborators
Leiden University Medical Center
Investigators
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Principal Investigator: Leo Visser, M, PhD LUMC
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Responsible Party: Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02276625    
Other Study ID Numbers: R5
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases