A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-05

Study Completion Date

2022-12-23

Brief Summary

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The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in participants who received a primary series of accelerated or conventional rabies PrEP IM regimen.

This product has been transferred to BN. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on www.clinicaltrials.gov.

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Detailed Description

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Conditions

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Virus Diseases Rabies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Conv-R/JE Group

Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49\_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (\<)0.5 IU/mL at scheduled visits.

Group Type EXPERIMENTAL

Rabipur

Intervention Type BIOLOGICAL

Participants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm.

Blood sampling

Intervention Type PROCEDURE

Blood samples were drawn from all participants at Day 1 and then at subsequent year intervals from extension study Day 1 onwards.

Purified Chick-Embryo Cell Rabies Vaccine

Intervention Type BIOLOGICAL

1 booster dose of 1.0 mL of Purified Chick-Embryo Cell Rabies Vaccine intramuscular (IM).

Acc-R/JE Group

Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49\_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were \<0.5 IU/mL at scheduled visits.

Group Type EXPERIMENTAL

Rabipur

Intervention Type BIOLOGICAL

Participants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm.

Blood sampling

Intervention Type PROCEDURE

Blood samples were drawn from all participants at Day 1 and then at subsequent year intervals from extension study Day 1 onwards.

Conv-R Group

Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49\_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were \<0.5 IU/mL at scheduled visits.

Group Type EXPERIMENTAL

Rabipur

Intervention Type BIOLOGICAL

Participants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm.

Blood sampling

Intervention Type PROCEDURE

Blood samples were drawn from all participants at Day 1 and then at subsequent year intervals from extension study Day 1 onwards.

Interventions

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Rabipur

Participants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm.

Intervention Type BIOLOGICAL

Blood sampling

Blood samples were drawn from all participants at Day 1 and then at subsequent year intervals from extension study Day 1 onwards.

Intervention Type PROCEDURE

Purified Chick-Embryo Cell Rabies Vaccine

1 booster dose of 1.0 mL of Purified Chick-Embryo Cell Rabies Vaccine intramuscular (IM).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* All individuals who were randomized to a Rabies primary series vaccination for pre-exposure prophylaxis (PrEP), received the full PrEP regimen and completed the parent trial following study protocol.

Exclusion Criteria

* Completed the parent study without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen.
* History of exposure to suspected or confirmed rabid animal.
* Receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of the parent study

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes