A study to compare the efficacy of an intradermal and an intramuscular single-visit dosing regimen of the rabies vaccine in adults

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institute Of Tropical Medicine

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

11 Jan 2023 → 28 Aug 2025

Decision date (initial)

2024-04-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Belgian Armed Forces

External identifiers

EU CT number

2024-511506-22-00

EudraCT number

2022-002367-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To determine if a 4 x 0.1 mL ID or a 1 x 1.0 mL IM priming dose is clinically not inferior to the standard of care schedule as assessed by boostability (percentage of subjects that have rabies antibodies ≥ 0.5
IU/mL) 7 days after booster doses.

Secondary objectives 7

1. Assess serological response (titre ≥ 3.0 IU/ml) 7 & 28 days after the booster vaccination in all arms.
2. Assess the serological response (titre ≥ 10 IU/ml) 7 & 28 days after the booster vaccination in all arms.
3. Assess seroconversion at day 28 after pre-exposure vaccination for the 3 regimens. A titre ≥ 0.5 IU/ml is considered as successful seroconversion.
4. Assess the serological response (≥ 0.5 IU/ml) at all other visits for the different arms.
5. Determine which vaccination schedule results in the steepest slope of difference in antibody response between the successive visits after the booster.
6. Estimate the difference in antibody response for each arm between day of the booster and day 7, day 28, and day 90 after the booster.
7. Assess the geometric mean titres at all visits for the 3 arms and compare the GMTs between the respective intervention groups and the standard of care group.

Conditions and MedDRA coding

Rabies

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. ≥18 to ≤60 years of age at time of inclusion
2. Willingness to provide written informed consent
3. Permanent residency in Belgium during the study period
4. Prepared to follow the study schedule
5. Willing to use contraception during 1 month after each vaccination (only for women of childbearing potential)

Exclusion criteria 6

1. Any vaccination against rabies (memorised or stated in the vaccination certificate)
2. Known allergy to one of the components of the vaccines
3. Immunocompromised subjects or subjects who take immunosuppressant and/or –stimulant medication
4. Planned overseas deployment during the study period
5. Ongoing pregnancy or active child wish during the study period (for female subjects)
6. Planned vaccination with any inactivated vaccine within 2 weeks before or after each vaccination or with any live attenuated vaccine within 1 month before or after each vaccination

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in boostability on day 7 after the booster between the respective intervention groups and the standard of care group.

Secondary endpoints 7

1. Percentage of subjects that have rabies antibodies ≥3.0 IU/ml on day 7 and day 28 after booster vaccination in all groups.
2. Percentage of subjects that have rabies antibodies ≥10.0 IU/ml on day 7 and day 28 after booster vaccination in all groups.
3. Percentage of subjects that have rabies antibodies ≥ 0.5 IU/ml on day 28 after pre-exposure vaccination in all groups
4. Percentage of subjects that have rabies antibodies ≥ 0.5 IU/ml at every visit for each regimen.
5. Rabies serology slopes between the successive visits after the booster in all groups
6. Mean difference in antibody response between day of the booster and day 7, day 28, and day 90 after the booster.
7. GMTs at all visits in all arms and the ratio between the GMTs in the intervention arms respectively and the standard of care arm.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institute Of Tropical Medicine

Sponsor organisation

Institute Of Tropical Medicine

Address

Nationalestraat 155

City

Antwerp

Postcode

2000

Country

Belgium

Scientific contact point

Organisation

Institute Of Tropical Medicine

Contact name

Patrick Soentjens

Public contact point

Organisation

Institute Of Tropical Medicine

Contact name

Natacha Herssens

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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