CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 500 enrolled
Drug / intervention
Human Diploid Cell Vaccine (HDCV) rabies vaccinebiological
Likely dose
Human Diploid Cell Vaccine (HDCV) rabies vaccine 1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01388985
NCT01388985Phase 3Completed

Simplifying the Rabies Pre-exposure Vaccination

Institute of Tropical Medicine, Belgium·interventional·Posted Jul 7, 2011·Updated May 14, 2019

In Brief

A Phase 3 clinical trial evaluating Human Diploid Cell Vaccine (HDCV) rabies vaccine for Rabies. Completed, enrolled 500 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRabies
CountriesBelgium

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2011
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.0 years ago

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