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How well does the immune system remember rabies immunization after one or two injections?


- candidate number28169
- NTR NumberNTR6817
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-nov-2017
- Secondary IDsNL60550.056.17; 2017-000089-31 CCMO-code; EudraCT-number
- Public TitleHow well does the immune system remember rabies immunization after one or two injections?
- Scientific TitleSingle dose rabies PRE-exposure Priming induces a rapid and effective anamnestic Antibody Response
- ACRONYMPREPARE
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedRabies, Lyssavirus
- Inclusion criteriaTravellers 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 criteriaA 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-mei-2018
- planned closingdate1-jan-2020
- Target number of participants246
- InterventionsTwo 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
- Primary outcomeRate of increase of GMC of RVNA between day 0 and day 7 after simulated PEP.
- Secondary outcomePercentage 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
- TimepointsPrimare 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
- Trial web sitewww.rabiesvaccinatie.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Corine Prins
- CONTACT for SCIENTIFIC QUERIESMD. PhD. L.G. Visser
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Infectious Diseases
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD9-nov-2017 - 20-okt-2018


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