E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteer |
gezonde vrijwilliger |
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E.1.1.1 | Medical condition in easily understood language |
rabies vaccination |
inenting tegen hondsdolheid |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069589 |
E.1.2 | Term | Rabies immunization |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the presence of rapid and adequate anamnestic antibody response against rabies virus at six months after primary vaccination with a single intramuscular dose (1.0 mL) or one-fifth fractional intradermal dose of rabies vaccine. The rate of increase in geometric mean concentrations of RVNA observed at day 7, after a standard 2-dose PEP vaccination schedule should be non-inferior to that of the reference group with 2-dose PrEP. |
Aantonen dat het immunologisch geheugen na primo-rabies vaccinatie via intramusculaire weg met een enkelvoudige standaard dosis (1.0 mL) of via intradermale weg met een een-vijfde fractionele dosis (2 x 0.1 mL) even goed kan worden aangesproken (non-inferieur) als na standaard primo-vaccinatie met 2 i.m. dosis |
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E.2.2 | Secondary objectives of the trial |
To determine health beliefs, knowledge and risk perception on animal bites and rabies, and attitude towards vaccination in these travellers before and after travel |
Vaststellen van kennis, risico perceptie en eigen ideeën over bijverwondingen en rabies en de houding van reizigers tegenover rabiesvaccinatie voor en na de reis |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Travellers visiting the travel clinics of AMC, Harbour Hospital and LUMC will be invited to participate in this study. In order to be eligible to participate in this study, a subject must meet all of the following criteria: Age ≥18 years Expected time of departure >1 weeks Travelling for less than 8 weeks Good health according to investigator Willingness and ability to adhere to the study regimen Able to provide informed consent |
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E.4 | Principal exclusion criteria |
History of previous rabies vaccination Suspected previous vaccination against rabies Requirement for standard rabies PrEP according to the national guidelines Known or suspected previous vaccination against rabies Known or suspected severe allergy against egg protein Known or suspected allergy against any of the other vaccine components History of unusual or severe reactions to any previous vaccination History of (pre)syncope associated with medical procedures involving needles Immunocompromized state due to illness or medication Administration of plasma or blood products three months prior to inclusion (hydroxy)chloroquine or mefloquine use History of any neurological disorder including epilepsy Pregnancy or breastfeeding Any current infectious disease other than seasonal cold Bleeding disorders or use of anticoagulants Temporary exclusion criterion for vaccination: body temperature ≥ 38.5°C or acute illness will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of increase of GMC of RVNA between day 0 and day 7 after simulated PEP
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Percentage of travellers with RVNA titer >0.5 IU/mL at day 0, six months after primary vaccination Percentage of travellers with RVNA titer>0.5 IU/mL at day 3, after the simulated post-exposure vaccination
GMC of RVNA at 0, day 56-63, and 6 months after a single intramuscular dose of rabies vaccine GMC of RVNA at 0, day 56-63, and 6 months after a two-site intradermal one-fifth fractional doses of rabies vaccine GMC of RVNA at 0, day 63-70 and 6 months after standard PrEP with 2 intramuscular doses of rabies vaccine GMC of RVNA at day 0, day 3, day 7 and day 21 after the simulated post-exposure vaccination
Knowledge, belief and risk perception about animal bites and rabies vaccination, before and after travel Percentage of travellers with animal contact during stay abroad
Type of animal and type of contact (licking, scratching or biting)
Measures taken after animal contact during travel Percentage of travellers who applied wound care after animal contact Percentage of travellers who started appropriate PEP after animal contact
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0, Day 3, Day 7, Day 56-63/63-70, month 6, month 6 + 3 days, month 6 + 7 days, months 6 + 21 days |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
laboratory (RVNA) blinded from allocation |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard vaccination schedule |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |