Overview

This trial is active, not recruiting.

Condition rabies
Treatment purified chick-embryo cell rabies vaccine
Phase phase 3
Sponsor GlaxoSmithKline
Start date October 2015
End date December 2022
Trial size 578 participants
Trial identifier NCT02545517, 2015-000382-31, 205214, v49_23E1

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 subjects who received a primary series of accelerated or conventional rabies PrEP IM regimen.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose prevention
Masking no masking
Arm
(Experimental)
Subjects who received a primary series of accelerated or conventional rabies PrEP IM regimen in the parent study, will receive a booster dose based on their individual antibody concentrations measured over time.
purified chick-embryo cell rabies vaccine
1 booster dose of 1.0 mL of Purified Chick-Embryo Cell Rabies Vaccine intramuscular (IM)

Primary Outcomes

Measure
The primary immunogenicity endpoints will be based on the concentrations at Year 3, following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
time frame: Year 3
The primary immunogenicity endpoints will be based on the concentrations at Year 4 following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
time frame: Year 4
The primary immunogenicity endpoints will be based on the concentrations at Year 5 following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
time frame: Year 5
The primary immunogenicity endpoints will be based on the concentrations at Year 6 following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
time frame: Year 6
The primary immunogenicity endpoints will be based on the concentrations at Year 7 following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
time frame: Year 7
The primary immunogenicity endpoints will be based on the concentrations at Year 8 following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
time frame: Year 8
The primary immunogenicity endpoints will be based on the concentrations at Year 9 following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
time frame: Year 9
The primary immunogenicity endpoints will be based on the concentrations at Year 10 following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
time frame: Year 10
Time to first RVNA concentrations < 0.5 IU/mL.
time frame: All study duration (outcome measure is a time so we cannot specify the particular timepoint)
Geometric Mean Concentrations (GMCs) for subjects receiving the booster dose at 7 days after the booster dose
time frame: 7 days after the booster dose.
Geometric Mean Concentrations (GMCs) for subjects receiving the booster dose.
time frame: before the booster dose.
Geometric Mean Ratios (GMRs) for subjects receiving the booster dose, as measured by antibody concentration at 7 days after the booster dose vs. antibody concentration before the booster dose.
time frame: 7 days after the booster dose vs. antibody concentration before the booster dose.
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.
time frame: Year 3
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.
time frame: Year 4
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.
time frame: Year 5
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.
time frame: Year 6
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.
time frame: Year 7
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.
time frame: Year 8
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.
time frame: Year 9
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.
time frame: Year 10

Secondary Outcomes

Measure
Geometric Mean Antibody Concentrations (GMCs) at Year 3.
time frame: Year 3
Geometric Mean Antibody Concentrations (GMCs) at Year 4.
time frame: Year 4
Geometric Mean Antibody Concentrations (GMCs) at Year 5.
time frame: Year 5
Geometric Mean Antibody Concentrations (GMCs) at Year 6.
time frame: Year 6
Geometric Mean Antibody Concentrations (GMCs) at Year 7.
time frame: Year 7
Geometric Mean Antibody Concentrations (GMCs) at Year 8.
time frame: Year 8
Geometric Mean Antibody Concentrations (GMCs) at Year 9.
time frame: Year 9
Geometric Mean Antibody Concentrations (GMCs) at Year 10.
time frame: Year 10
Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥ 0.5 IU/mL at Year 3.
time frame: Year 3
Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥ 0.5 IU/mL at Year 4.
time frame: Year 4
Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥ 0.5 IU/mL at Year 5.
time frame: Year 5
Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥ 0.5 IU/mL at Year 6.
time frame: Year 6
Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥ 0.5 IU/mL at Year 7.
time frame: Year 7
Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥ 0.5 IU/mL at Year 8.
time frame: Year 8
Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥ 0.5 IU/mL at Year 9.
time frame: Year 9
Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥ 0.5 IU/mL at Year 10.
time frame: Year 10
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 3.
time frame: Year 3.
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 4.
time frame: Year 4.
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 5.
time frame: Year 5.
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 6.
time frame: Year 6.
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 7.
time frame: Year 7.
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 8.
time frame: Year 8.
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 9.
time frame: Year 9.
Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 10.
time frame: Year 10.

Eligibility Criteria

All participants of any age.

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

Additional Information

Official title A Phase 3, Open-label, Multicenter Study to Evaluate Long-term Immunogenicity and Boostability of Immune Responses in Adults Who Received Different Primary Vaccination Regimens of Pre-exposure Prophylaxis With Purified Chick-Embryo Cell Rabies Vaccine Administered Concomitantly or Separately From a Japanese Encephalitis Vaccine.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.