NCT02276625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

October 24, 2014

Last Update Submit

October 27, 2014

Conditions

Rabies Pre-exposure Prophylaxis

Outcome Measures

Primary Outcomes (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)

    1 year

Study Arms (4)

A - ID

EXPERIMENTAL

Intradermal administration. 20% dose in a single visit.

Biological: rabies vaccine

B - ID

EXPERIMENTAL

Intradermal administration. 40% dose in a single visit.

Biological: rabies vaccine

C - ID

EXPERIMENTAL

Intradermal administration. 60% dose in a single visit.

Biological: rabies vaccine

D - IM

ACTIVE COMPARATOR

1x IM

Biological: rabies vaccine

Interventions

rabies vaccineBIOLOGICAL

Compare ID administration to IM administration. 1 visit schedule.

A - IDB - IDC - IDD - IM

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 years
  • Good health according to the investigator
  • Willingness and ability to adhere to the study regimen
  • Able to give informed consent

You may not qualify if:

  • 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
  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Interventions

Rabies Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Leo Visser, M, PhD

    LUMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emile Jonker, MD

CONTACT

e.f.f.jonker@lumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

NL(1)