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

A two-centre open-label non-inferiority trial to assess the immunogenicity and safety of an intradermal and an intramuscular single-visit dosing regimen of purified chick-embryo cell-culture rabies vaccine in adults - SingleR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002367-29-BE

Enrollment

360

Registered

2022-08-30

Start date

2022-09-29

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies is a viral infection that affects the central nervous system. It causes encephalitis which is almost invariably fatal. Preventive vaccination alone implies no complete protection, but simplifies the postexposure procedure considerably, as the immunological response comes much more rapid in case of a booster vaccination post-exposure. This lowers the risk of morbidity and mortality. MedDRA version: 20.0 Level: PT Classification code 10037742 Term: Rabies System Organ Class: 10021881 - Inf

Interventions

Trade Name: Rabipur Product Name: Rabipur Pharmaceutical Form: Powder and solvent for solution for injection in pre-filled syringe INN or Proposed INN: J07BG01 Other descriptive name: RABIES VIRUS (IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 6. Any vaccination against rabies (memorised or stated in the vaccination certificate) 7. Known allergy to one of the components of the vaccines 8. Immunocompromised subjects or subjects who take immunosuppressant and/or –stimulant medication 9. Planned overseas deployment during the study period 10. Ongoing pregnancy or active child wish during the study period (for female subjects) 11. 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 Objective: 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.;Primary end point(s): Difference in boostability on day 7 after the booster between the respective intervention groups and the standard of care group.;Timepoint(s) of evaluation of this end point: Day 7 after booster vaccination	—

Measure

Time frame

Main Objective: 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 Objective: 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.;Primary end point(s): Difference in boostability on day 7 after the booster between the respective intervention groups and the standard of care group.;Timepoint(s) of evaluation of this end point: Day 7 after booster vaccination

—

Secondary

Measure	Time frame
Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: Endpoint 1 &2: day 7 and day 28 after booster vaccination Endpoint 3: day 28 after boster Endpoint 4 & 5 &7: at every visit Endpoint 6: day 7, day 28, and day 90 after the booster	—

Measure

Time frame

Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: Endpoint 1 &2: day 7 and day 28 after booster vaccination Endpoint 3: day 28 after boster Endpoint 4 & 5 &7: at every visit Endpoint 6: day 7, day 28, and day 90 after the booster

—

Countries

Belgium

Contacts

Public ContactClinical Trial Unit

Instituut van Tropische Geneeskunde Antwerpen

ctu@itg.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026