Phase 3 N=459 Prevention

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 · Rabies

Bottom Line

View on ClinicalTrials.gov: NCT02545517 ↗

Enrolled (actual)

459

Serious AEs

3.5%

Results posted

Jul 2024

Primary outcome: Primary: Number of Participants Reporting Serious Adverse Events (SAEs) After a Booster Dose of Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine — 2; 0; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rabipur (Biological); Blood sampling (Procedure); Purified Chick-Embryo Cell Rabies Vaccine (Biological)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting Serious Adverse Events (SAEs) After a Booster Dose of Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine	2; 0; 3	—
PRIMARY 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	1; 1; 2	—
PRIMARY Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 3 and Year 4	5; 5; 7	—
PRIMARY Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 4 and Year 5	7; 0; 4	—
PRIMARY Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 5 and Year 6	3; 2; 10	—
PRIMARY Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 6 and Year 7	0; 2; 0	—
PRIMARY Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 7 and Year 8	0; 0; 0	—
PRIMARY Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 8 and Year 9	1; 0; 2	—
PRIMARY Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 9 and Year 10	2; 0; 0	—
PRIMARY RVNA Antibody Concentrations 7 Days After the Booster Dose	4.2; 4.2; 4.4	—
PRIMARY RVNA Geometric Mean Ratios (GMRs) 7 Days After the Booster Dose Versus Antibody Concentrations Before the Booster Dose	23.6; 23.4; 19.3	—
PRIMARY Percentage of Participants With RVNA Concentrations Greater Than or Equal to (>=) 0.5 IU/mL, 7 Days After Booster Dose	95.3; 89.1; 98.1	—
PRIMARY Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 3	81.6; 78.8; 84.9	—
PRIMARY Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 4	74.4; 70.8; 76.5	—
PRIMARY Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 5	66.1; 69.1; 73.1	—
PRIMARY Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 6	60.9; 66.2; 66.5	—
PRIMARY Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 7	60.2; 64.4; 67.3	—
PRIMARY Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 8	59.8; 64.1; 64.6	—
PRIMARY Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 9	59.3; 63.6; 64.0	—
PRIMARY Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 10	56.2; 62.3; 62.7	—
SECONDARY Rabies Virus Neutralizing Antibody Concentrations	1.21; 1.16; 1.3; 0.69; 0.73; 0.82	—
SECONDARY Reverse Cumulative Percentage for Participants With RVNA Concentrations >=0.5 IU/mL	100; 100; 100; 83; 84; 83	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02545517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.