No registrations found.
ID
Source
Brief title
Health condition
Rabies, lyssavirus, rabiës, hondsdolheid
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of increase of GMC of RVNA between day 0 and day 7 after simulated PEP.
Secondary outcome
Percentage of travellers with RVNA titer >0.5 IU/mL at day
0, two months, and six months after primary
vaccination. Percentage of travellers with RVNA titers>0.5
IU/mL at day 3, after the simulated post-exposure
vaccination. Percentage of travellers with RVNA titers>3
IU/mL, and percentage of travellers with RVNA titers >5
IU/mL at day 7 after simulated PEP.
GMC of RVNA at 0, 2, and 6 months after a single
intramuscular dose of rabies vaccine
GMC of RVNA at 0, 2, and 6 months after a two-site
intradermal one-fifth fractional doses of rabies vaccine
GMC of RVNA at 0, 2, 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
Background summary
The main purpose of prophylactic rabies pre-exposure immunization (PrEP) is to induce an effective and rapid anamnestic antibody response after revaccination that obviates the need for human rabies immunoglobulins (RIG) and simplifies post-exposure immunization (PEP) to just 2 doses of rabies vaccine (D0, D3).
Many travellers decline pre-travel PrEP because of costs and insufficient time between visit at the travel clinic and departure.
The aim of this study is to demonstrate that a single dose of rabies vaccine can induce an equally rapid and adequate anamnestic antibody response as 2-dose PrEP to revaccination six months later.
Travellers will be randomized between 2-dose PrEP, single dose PrEP (standard intramuscular dose or one-fifth fractional intradermal dose) and no PrEP before travel. After 6 months, all subjects receive a simulated 2-dose post-exposure vaccination schedule (D0 and D3).
Serum samples are collected at 0, 2, and 6 months after PrEP, and at 0, 3, 7 and 21 days after the simulated post-exposure vaccinations.
The primary endpoint is the rate of increase of geometric mean concentrations (GMC) of neutralizing antibodies between day 0 and day 7 after revaccination for the different study groups.
If PrEP with a single dose of rabies vaccine would be equally effective in inducing a rapid and adequate anamnestic antibody response, RIG would not be no longer required in case of high risk bite wounds in (returning) travellers. Guidelines on pre-travel PrEP could be simplified. Pre-travel rabies PrEP would come within reach of most travellers.
Study objective
The aim of this study is to demonstrate that a single dose of rabies vaccine can induce an equally rapid and adequate anamnestic antibody response as 2-dose PrEP to revaccination six months later.
Study design
Primare outcome: D0 and 7 after simulated PEP (month 6 + 0 days and month 6 + 7 days)
Secondary outcomes: D0, 3, 7, 56-63 after primary vaccination and D0, 3, 7 and 21 after simulated PEP
Intervention
Two intervention groups:
- Study group A – single standard dose of 1.0 mL rabies vaccine on D0
- Study group B – two fractional doses of 0.1 mL rabies vaccine by intradermal route at different sites on D0
Two control groups:
- Study group C (positive control) – wo-dose
(1.0 mL) intramuscular PrEP vaccination (D0, D7)
- Study group D (negative control) – no rabies vaccination
before travel
Inclusion criteria
Travellers visiting the travel clinics of AMC, LUMC and the ‘Tropen Advies Centrum – Travel Clinic
Havenziekenhuis’ 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 week
• 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
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• History of previous rabies vaccination
• Requirement for standard rabies PrEP according to the national guidelines
• 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6600 |
| NTR-old | NTR6817 |
| CCMO | NL60550.056.17 |
| OMON | NL-OMON45358 |