Rabies is a viral infection that affects the central nervous system. It causes encephalitis which is almost invariably fatal. Preventive vaccination alone implies no complete protection, but simplifies the post-exposure procedure considerably, as the immunological response comes much more rapid in case of a booster vaccination post-exposure. This lowers the risk of morbidity and mortality.
Conditions
Interventions
Trade Name: Rabipur
Product Name: Rabipur
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: /
CAS Number: /
Current Sponsor code: /
Other descriptive name: RABIES VIRUS
Sponsors
Institute of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: » Willingness to provide written consent » Seronegative for rabies » Belgian soldiers or military students who are deployable but not for an high rabies risk area (as land deployment to Africa or Asia) » Prepared to follow the study schedule Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 28 days. » Planned deployment to high rabies risk areas within 2 years; for example (as land deployment to Africa or Asia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine if a 2 x 0,1 ml priming dose results in an acceptable boostability (% of subjects that have boostable rabies antibodies) after 1 year. - To determine the lowest booster dose (4 x 0,1 ml, or 2 x 0,1 ml) after a 2 x 0,1 ml priming dose needed to induce an acceptable boostability after 1 year. - A vaccination regimen is considered to have an acceptable boostability if at least 90% of vaccinated subjects would reach a rabies titre of > 0.5 IU/mL 7 days after booster vaccination. This will be assessed by comparing the one-sided 95% confidence interval for the % of boostable subjects with the target value of 90%. If the one-sided 95% confidence interval excludes 90%, an acceptable boostability is considered to be established. ;Secondary Objective: - To assess good protection after primary vaccination and booster vaccination in both treatment groups (day 372). A titer > 3 IU/ml is considered to give good protection. - To assess long lasting protection after primary vaccination and booster vaccination in both treatment groups (day 372). A titer > 10 IU/ml is considered to give long-lasting immunity. - To investigate the serological response after the primary vaccination (on day 7) in both treatment groups. A titer = 0,5 IU/ml is considered to be boostable. ;Primary end point(s): The primary endpoint is the boostability of the rabies antibodies on day 7 after booster vaccination at 1 year after initial vaccination. A rabies serology value of more than 3 IU/ml on day 7 after booster vaccination is considered to be protective. Subjects showing this serology value at day 7 are considered to be boostable. ;Timepoint(s) of evaluation of this end point: day 7 after booster vaccination at 1 year after initial vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rabies serology more than 3 IU/ml on day 7 after simulated booster vaccination. - Rabies serology more than 10 IU/ml on day 7 after simulated booster vaccination. - The initial long lasting protection (= rabies serology more than 10 IU/ml on day 7 after primary vaccination) after primary vaccination will be determined. - Rabies serology more than 0,5 IU/ml on day 7 after primary vaccination in both arms. - Serological response of booster vaccination for non-responders in both arms. - Adverse events within one week after initial and booster vaccinations and serious adverse event within 14 days after initial and booster vaccinations (as described in section 7). ;Timepoint(s) of evaluation of this end point: day 7 after simulated booster vaccination 14 days after initial and booster vaccinations | — |
Countries
Belgium
Contacts
Public ContactClinical Trials Unit
Institute of Tropical Medicine
Outcome results
None listed