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Purified Chick-Embryo Cell Rabies Vaccine

Phase 3

Virus Diseases | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jul 18, 2024

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment459

FDA Designations

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Clinical trial landscape

Purified Chick-Embryo Cell Rabies Vaccine · 1 trial · 2 indications

Phase 3 1
NCT02545517A 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.Virus Diseases
COMPLETED459 Analytics
PHASE3COMPLETED
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.
Virus Diseases
NCT02545517459
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Study Endpoints

Primary Endpoints

Number of Participants Reporting Serious Adverse Events (SAEs) After a Booster Dose of Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine
From booster vaccination [6 to 9 months after Year 3 (3 years after primary series of vaccination)] up until completion of the safety follow-up period (10 years after primary series of vaccination)

A SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required/prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the participants or may require intervention to prevent one of the other outcomes listed. Safety is assessed as the number of participants reporting SAEs after a booster dose of PCEC rabies vaccine administered in this extension study, if RNVA concentrations were \<0.5 IU/mL, following a primary series of accelerated or conventional rabies pre-exposure (PrEP) intramuscular (IM) regimen in the parent study.

Number of Participants Who Had Their Rabies Virus Neutralizing Antibody (RNVA) Concentrations Drop Below 0.5 International Units (IU) Per Milliliter (mL) Between Day 366 and Year 3
Day 366 to Year 3 (after primary series of vaccination)
Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 3 and Year 4
Year 3 to Year 4 (after primary series of vaccination)
Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 4 and Year 5
Year 4 to Year 5 (after primary series of vaccination)
Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 5 and Year 6
Year 5 to Year 6 (after primary series of vaccination)
Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 6 and Year 7
Year 6 to Year 7 (after primary series of vaccination)
Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 7 and Year 8
Year 7 to Year 8 (after primary series of vaccination)
Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 8 and Year 9
Year 8 to Year 9 (after primary series of vaccination)
Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 9 and Year 10
Year 9 to Year 10 (after primary series of vaccination)
RVNA Antibody Concentrations 7 Days After the Booster Dose
At Day 7 after booster dose

RVNA antibody concentrations were measured in terms of Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.

RVNA Geometric Mean Ratios (GMRs) 7 Days After the Booster Dose Versus Antibody Concentrations Before the Booster Dose
Day 7 after booster dose compared to baseline (7 days before booster dose)

GMR was calculated as ratio of post booster dose RVNA GMCs (7-day post booster dose) to the baseline RVNA GMCs (7 days before booster dose). The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.

Percentage of Participants With RVNA Concentrations Greater Than or Equal to (>=) 0.5 IU/mL, 7 Days After Booster Dose
At Day 7 after booster dose

The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 3
At Year 3 after primary series of vaccine administration
Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 4
At Year 4 after primary series of vaccine administration
Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 5
At Year 5 after primary series of vaccine administration
Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 6
At Year 6 after primary series of vaccine administration
Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 7
At Year 7 after primary series of vaccine administration
Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 8
At Year 8 after primary series of vaccine administration
Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 9
At Year 9 after primary series of vaccine administration
Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 10
At Year 10 after primary series of vaccine administration

Secondary Endpoints

Rabies Virus Neutralizing Antibody Concentrations
At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration
Reverse Cumulative Percentage for Participants With RVNA Concentrations >=0.5 IU/mL
At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Conv-R/JE GroupEXPERIMENTALParticipants 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.
Acc-R/JE GroupEXPERIMENTALParticipants 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.
Conv-R GroupEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
RabipurBIOLOGICALParticipants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm.
Blood samplingPROCEDUREBlood 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 VaccineBIOLOGICAL1 booster dose of 1.0 mL of Purified Chick-Embryo Cell Rabies Vaccine intramuscular (IM).
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Eligibility Criteria

SexALL
Healthy VolunteersYes
Study Sites7

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...

Countries:AustriaGermanySwitzerland
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