Five-year boostability after single-visit single-dose intramuscular rabies pre-exposure prophylaxis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Academisch Ziekenhuis Leiden

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

19 Sep 2024 → ongoing

Decision date (initial)

2024-09-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-510480-35-00

EudraCT number

2021-005564-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To demonstrate the presence of a rapid and adequate anamnestic antibody response against rabies virus vaccine five years after primary vaccination with a single intramuscular dose (1.0 mL) of rabies vaccine. The rate of increase in geometric mean concentrations of RVNA observed at day 8 after a simulated standard 2-dose PEP vaccination schedule should be non-inferior to that of the reference group who received primary vaccination with two-visit, single-dose PrEP.

Secondary objectives 2

1. To describe the kinetics of rabies virus neutralizing antibody levels in healthy young adults, who received single-visit single-dose rabies PrEP or two-visit PrEP, during a five-year follow-up.
2. To describe the kinetics of rabies-specific memory B-cells in healthy young adults, who received single-visit single-dose rabies PrEP or two-visit PrEP, during a five-year follow-up.

Conditions and MedDRA coding

viral infections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age between 18 and 40 years
2. Good health according to investigator
3. Willingness and ability to adhere to the study regimen
4. Able to provide informed consent
5. Naïve to rabies exposure or vaccination
6. Willing to comply to a follow-up of 5 years
7. Unlikely to require rabies PrEP in next 5 years

Exclusion criteria 13

1. History of previous rabies vaccination
2. Suspected previous vaccination against rabies
3. Known or suspected severe allergy against egg protein
4. Known or suspected allergy against any of the other vaccine components
5. History of unusual or severe reactions to any previous vaccination
6. History of (pre)syncope associated with medical procedures involving n
7. Immunocompromized state due to illness or medication
8. Administration of plasma or blood products three months prior to inclusion
9. (hydroxy)chloroquine or mefloquine use
10. History of any neurological disorder including epilepsy
11. Pregnancy or breastfeeding during study visits in which the participant is vaccinated
12. Any current infectious disease other than seasonal cold
13. Bleeding disorders or use of anticoagulants

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the rate of increase of geometric mean concentrations (GMC) of neutralizing antibodies between day 1 and day 8 after revaccination

Secondary endpoints 4

1. Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination.
2. Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D8 and D15 after the simulated post-exposure vaccination
3. Percentage of subjects with RVNA titer >3 IU/mL, and percentage of subjects with RVNA titers >5 IU/mL at day 8 after simulated PEP.
4. GMCs at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination, and at D1, D8 and D15 after the simulated post-exposure vaccination

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Academisch Ziekenhuis Leiden

Sponsor organisation

Academisch Ziekenhuis Leiden

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Principal Investigator

Public contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Principal Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications