Rabies Clinical Trial
Official title:
Simplifying the Rabies Pre-exposure Vaccination
Verified date | April 2019 |
Source | Institute of Tropical Medicine, Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 47 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Military Hospital | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium | Belgian Scientific Institute of Public Health, Military Hospital, Brussels |
Belgium,
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 th — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Participants With a Rabies Serology More Than 0.5IU/ml After Primary Vaccination | Number of participants that have a Rabies serology more than 0,5 IU/ml on day 35 after primary vaccination. | Day 35 after primary (initial) vaccination | |
Secondary | Number of Particpants With a Rabies Serology More Than 10IU/ml After Primary and Booster Vaccination | Number of participants that have a Rabies serology more than 10 IU/ml on day 35 after primary vaccination, and after booster vaccination. | Day 35 after primary (initial) vaccination, and after booster vaccination | |
Secondary | Number of Particpants Experiencing Adverse Events | Number of participants experiencing Adverse events within one week after initial and booster vaccinations | One week after initial and booster vaccination | |
Secondary | Number of Participants Experiencing Serious Adverse Events | Number of participants experiencing a Serious adverse event within 28 days after initial and booster vaccinations | 28 days after initial and booster vaccination |
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