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Completed

NCT Number: 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.

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 GSK Clinical Study Register is no longer maintained for this study.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

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Key information

Conditions

Virus Diseases Infections Mononegavirales Infections RNA Virus Infections Rabies Rhabdoviridae Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabipur

Biological

Participants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm.

blood sampling

Procedure

Blood 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 vaccine

Biological

1 booster dose of 1.0 mL of Purified Chick-Embryo Cell Rabies Vaccine intramuscular (IM).

Primary outcomes

  1. Number of Participants Reporting Serious Adverse Events (SAEs) After a Booster Dose of Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine

    Time frame: 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.

  2. 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

    Time frame: Day 366 to Year 3 (after primary series of vaccination)

  3. Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 3 and Year 4

    Time frame: Year 3 to Year 4 (after primary series of vaccination)

  4. Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 4 and Year 5

    Time frame: Year 4 to Year 5 (after primary series of vaccination)

  5. Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 5 and Year 6

    Time frame: Year 5 to Year 6 (after primary series of vaccination)

  6. Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 6 and Year 7

    Time frame: Year 6 to Year 7 (after primary series of vaccination)

  7. Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 7 and Year 8

    Time frame: Year 7 to Year 8 (after primary series of vaccination)

  8. Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 8 and Year 9

    Time frame: Year 8 to Year 9 (after primary series of vaccination)

  9. Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 9 and Year 10

    Time frame: Year 9 to Year 10 (after primary series of vaccination)

  10. RVNA Antibody Concentrations 7 Days After the Booster Dose

    Time frame: 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.

  11. RVNA Geometric Mean Ratios (GMRs) 7 Days After the Booster Dose Versus Antibody Concentrations Before the Booster Dose

    Time frame: 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.

  12. Percentage of Participants With RVNA Concentrations Greater Than or Equal to (>=) 0.5 IU/mL, 7 Days After Booster Dose

    Time frame: 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.

  13. Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 3

    Time frame: At Year 3 after primary series of vaccine administration

  14. Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 4

    Time frame: At Year 4 after primary series of vaccine administration

  15. Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 5

    Time frame: At Year 5 after primary series of vaccine administration

  16. Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 6

    Time frame: At Year 6 after primary series of vaccine administration

  17. Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 7

    Time frame: At Year 7 after primary series of vaccine administration

  18. Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 8

    Time frame: At Year 8 after primary series of vaccine administration

  19. Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 9

    Time frame: At Year 9 after primary series of vaccine administration

  20. Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 10

    Time frame: At Year 10 after primary series of vaccine administration

Secondary outcomes

  1. Rabies Virus Neutralizing Antibody Concentrations

    Time frame: At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration

    Antibody concentrations were measured in terms of GMCs and expressed in IU/mL.

  2. Reverse Cumulative Percentage for Participants With RVNA Concentrations >=0.5 IU/mL

    Time frame: At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration

    As specified in the statistical analysis plan, a graphical presentation of the Reverse Cumulative Distribution Plots for participants with RVNA concentrations >=0.5 IU/mL was analyzed for this outcome measure. Due to system constrains, only the reverse cumulative percentage values were reported, to depict the Reverse Cumulative Distribution Plots.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2015
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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