Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01365494
First received: May 30, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.


Condition Intervention Phase
Rabies
Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IV, Multi-center, Randomized, Open-label Study of PCECV (Rabipur®) Comparing the Immunogenicity and Safety of Two Different Simulated Post Exposure Schedules (Zagreb 2-1-1 Versus Essen Regimen 1-1-1-1-1) in Healthy Indian Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14 [ Time Frame: On Day 0 and Day 14 ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule


Secondary Outcome Measures:
  • Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42 [ Time Frame: Study day 7, 14 and 42 ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.

  • Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations [ Time Frame: Day 0, Day 7, Day 14 and Day 42 ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules

  • Percentages of Subjects Reporting Adverse Events (AEs) [ Time Frame: All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.


Enrollment: 250
Study Start Date: July 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A-Zagreb
Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.
Active Comparator: Group B-Essen
Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14, and 28)
Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine
Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females of age ≥ 18 years.
  2. Individuals who had given written consent.
  3. Individuals in good health and available for all the visits scheduled in the study.

Exclusion Criteria:

  1. Pregnancy or unwillingness to practice acceptable contraception.
  2. A history of Rabies vaccination.
  3. History of allergy to egg protein.
  4. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
  5. A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
  6. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.
  7. Treatment with an anti-malarial drug, up to two months prior to the study.
  8. Individuals who received any other vaccines within 28 days prior to enrollment.
  9. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
  10. Any planned surgery during the study period.
  11. Subjects who have cancer disorders excluding nonmelanotic skin cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365494

Locations
India
Kempegowda Institute of Medical Sciences Hospital (KIMS)
Bangalore, KA, India, 560070
Mandya Institute of Medical Sciences
Mandya, KA, India, 571401
Padmashree Dr. D.Y Patil Hospital
Pune, MS, India, 411018
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Director: Novartis Vaccines and Diagnostics Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01365494     History of Changes
Other Study ID Numbers: V49_25
Study First Received: May 30, 2011
Results First Received: January 28, 2014
Last Updated: April 3, 2014
Health Authority: India: Ministry of Health

Keywords provided by Novartis:
Rabies
rabies vaccines
post-exposure prophylaxis

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014