Overview

This trial is active, not recruiting.

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

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
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

Male or female 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 April 2016.
Information provided to ClinicalTrials.gov by Novartis.