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.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rabies; Virus Diseases

Treatments: Biological: Rabipur; Procedure: Blood sampling; Biological: Purified Chick-Embryo Cell Rabies Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545517

205214

V49_23E1 (Other Identifier)

2015-000382-31 (EudraCT Number)

Details and patient eligibility

About

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 GSK Clinical Study Register is no longer maintained for this study.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.

Enrollment: 459 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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459 participants in 3 patient groups

Conv-R/JE Group

Experimental group

Description:

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.

Treatment:

Biological: Purified Chick-Embryo Cell Rabies Vaccine

Procedure: Blood sampling

Biological: Rabipur

Acc-R/JE Group

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

Biological: Rabipur

Conv-R Group

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

Biological: Rabipur