Clinical trial NCT02545517: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Virus Diseases
Rabies
Keywords: Rabies disease
Pre-exposure (PrEP) or post exposure prophylaxis (PEP)
Long-term Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 459
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 GSK Clinical Study Register is no longer maintained for this study.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

Primary outcomes:
measure: Number of Participants Reporting Serious Adverse Events (SAEs) After a Booster Dose of Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine
timeFrame: 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)
measure: 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
timeFrame: Day 366 to Year 3 (after primary series of vaccination)
measure: Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 3 and Year 4
timeFrame: Year 3 to Year 4 (after primary series of vaccination)
measure: Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 4 and Year 5
timeFrame: Year 4 to Year 5 (after primary series of vaccination)
measure: Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 5 and Year 6
timeFrame: Year 5 to Year 6 (after primary series of vaccination)
measure: Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 6 and Year 7
timeFrame: Year 6 to Year 7 (after primary series of vaccination)
measure: Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 7 and Year 8
timeFrame: Year 7 to Year 8 (after primary series of vaccination)
measure: Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 8 and Year 9
timeFrame: Year 8 to Year 9 (after primary series of vaccination)
measure: Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 9 and Year 10
timeFrame: Year 9 to Year 10 (after primary series of vaccination)
measure: RVNA Antibody Concentrations 7 Days After the Booster Dose
timeFrame: At Day 7 after booster dose
measure: RVNA Geometric Mean Ratios (GMRs) 7 Days After the Booster Dose Versus Antibody Concentrations Before the Booster Dose
timeFrame: Day 7 after booster dose compared to baseline (7 days before booster dose)
measure: Percentage of Participants With RVNA Concentrations Greater Than or Equal to (>=) 0.5 IU/mL, 7 Days After Booster Dose
timeFrame: At Day 7 after booster dose
measure: Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 3
timeFrame: At Year 3 after primary series of vaccine administration
measure: Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 4
timeFrame: At Year 4 after primary series of vaccine administration
measure: Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 5
timeFrame: At Year 5 after primary series of vaccine administration
measure: Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 6
timeFrame: At Year 6 after primary series of vaccine administration
measure: Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 7
timeFrame: At Year 7 after primary series of vaccine administration
measure: Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 8
timeFrame: At Year 8 after primary series of vaccine administration
measure: Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 9
timeFrame: At Year 9 after primary series of vaccine administration
measure: Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 10
timeFrame: At Year 10 after primary series of vaccine administration
Secondary outcomes:
measure: Rabies Virus Neutralizing Antibody Concentrations
timeFrame: At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration
measure: Reverse Cumulative Percentage for Participants With RVNA Concentrations >=0.5 IU/mL
timeFrame: At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration
Other outcomes:
Locations:
city: Wien
country: Austria
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Zuerich
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: