NCT01388985

Brief Summary

Rabies is a viral zoonosis that causes an encephalitis, almost invariably fatal. It is widely distributed across the globe: the World Health Organization (WHO) estimates that about 2,4 billion people live in endemic areas for canine rabies. Vaccination of domestic animals is limited to industrialized and middle-income countries. The development of clinical rabies can be prevented through timely immunization after exposure: however, preventive vaccination simplifies the post-exposure procedure considerably, as immunoglobulins are no longer needed and less vaccine administrations are scheduled. Pre-exposure prophylaxis consists of an intramuscular (IM)of intradermal (ID) dose given on days 0, 7 and 21 or 28. The development of immunological memory after this vaccination is critical for the establishment of long lasting immunity. Subjects receiving a booster dose 1 year after pre-exposure prophylaxis segregate themselves into 'good' and 'poor' responders; the former may not need further boosters for 10 years, whereas the latter may need more frequent boosters. Until recently, guidelines in travel medicine recommended pre-exposure vaccination only for some risk groups. Since recent studies have shown the effectiveness of the ID vaccination, the policies are changing towards pre-exposure vaccination for a larger population, including travelers to endemic regions, where immunoglobulins and vaccine are often not readily available. Based on the above, the investigators must stress the concept of "boostability" after a risk exposure. However, the current pre-exposure vaccination scheme could be improved: a schedule of 1 week would be less time consuming, would improve compliance and give less interference with other prophylaxis measures, e.g. mefloquine. Two small studies suggest that a schedule of 1 week interval is as effective and immunogenic as the standard one. The investigators will investigate whether the accelerated schedule is as effective as the classical schedule, by carrying out a randomized, non-inferiority study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

March 6, 2019

Completed
Last Updated

May 14, 2019

Status Verified

April 1, 2019

Enrollment Period

4.3 years

First QC Date

July 5, 2011

Results QC Date

October 16, 2018

Last Update Submit

April 30, 2019

Conditions

Rabies

Keywords

RabiesVaccinationBoostability

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Boostability of the Rabies Antibodies After Booster Vaccination

    The primary endpoint is the number of particpants with a boostability of the rabies antibodies on day 7 after booster vaccination, carried out at years 1 to 3 after initial vaccination. A rabies serology value of more than 0,5 IU/ml (international unit/milliliter) on day 7 after booster vaccination is considered to be protective. Subjects showing this serology value at day 7 are considered to be boostable.

    Day 7 after booster vaccination

Secondary Outcomes (4)

  • Number of Participants With a Rabies Serology More Than 0.5IU/ml After Primary Vaccination

    Day 35 after primary (initial) vaccination

  • Number of Particpants With a Rabies Serology More Than 10IU/ml After Primary and Booster Vaccination

    Day 35 after primary (initial) vaccination, and after booster vaccination

  • Number of Particpants Experiencing Adverse Events

    One week after initial and booster vaccination

  • Number of Participants Experiencing Serious Adverse Events

    28 days after initial and booster vaccination

Study Arms (2)

Standard vaccination schedule

ACTIVE COMPARATOR

One injection will be given on three different days (day 0, day 7 and day 21 or 28)

Biological: Human Diploid Cell Vaccine (HDCV) rabies vaccine

Accelerated vaccination schedule

EXPERIMENTAL

Two injections will be given on the same day (day 0 and day 7): one on each forearm.

Biological: Human Diploid Cell Vaccine (HDCV) rabies vaccine

Interventions

Human Diploid Cell Vaccine (HDCV) rabies vaccineBIOLOGICAL

Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites

Accelerated vaccination scheduleStandard vaccination schedule

Eligibility Criteria

Age18 Years - 47 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willingness to provide written consent
  • Seronegative for rabies
  • Belgian soldiers who are deployable and visit the Travel clinic in Brussels during their preparation phase before deployment OR military students at the schools of Belgian Defense are eligible in preparation of an overseas exercise or during the scheduled vaccination program at the end of their studies
  • Prepared to follow the study schedule

You may not qualify if:

  • Subjects who have had rabies vaccination (complete or incomplete) in the past due to post-exposure prophylaxis.
  • Subjects with a known allergy to one of the components of the vaccine.
  • Immune depressed persons or intake of immunodepressant medication.
  • Subjects who take mefloquine
  • Planned deployment to overseas areas within 35 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Hospital

Brussels, B-1000, Belgium

Location

Related Publications (1)

  • Soentjens P, Andries P, Aerssens A, Tsoumanis A, Ravinetto R, Heuninckx W, van Loen H, Brochier B, Van Gucht S, Van Damme P, Van Herrewege Y, Bottieau E. Preexposure Intradermal Rabies Vaccination: A Noninferiority Trial in Healthy Adults on Shortening the Vaccination Schedule From 28 to 7 Days. Clin Infect Dis. 2019 Feb 1;68(4):607-614. doi: 10.1093/cid/ciy513.

    PMID: 29939243RESULT

Related Links

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Rhabdoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Dr. Patrick Soentjens
Organization
Institute of Tropical Medicine Antwerp
psoentjens@itg.be
+32 3 247 66 41

Study Officials

  • Patrick Soentjens, MD

    ITM and Military Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 7, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 14, 2019

Results First Posted

March 6, 2019

Record last verified: 2019-04

Locations

BE(1)