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

NCT01365494 | Completed Phase 4 Results

• 1 other identifier: V49_25
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Rabies

Keywords

Rabies; rabies vaccines; post-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14

  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

  On Day 0 and Day 14

Secondary Outcomes (3)

• Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42

  Study day 7, 14 and 42

• Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations

  Day 0, Day 7, Day 14 and Day 42

• Percentages of Subjects Reporting Adverse Events (AEs)

  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

Study Arms (2)

Group A-Zagreb

ACTIVE COMPARATOR

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

Group B-Essen

ACTIVE COMPARATOR

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

Interventions

Purified Chick Embryo Cell Inactivated Rabies Vaccine BIOLOGICAL

Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.

Group A-Zagreb; Group B-Essen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or unwillingness to practice acceptable contraception.
• A history of Rabies vaccination.
• History of allergy to egg protein.
• Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
• 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.
• Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.
• Treatment with an anti-malarial drug, up to two months prior to the study.
• Individuals who received any other vaccines within 28 days prior to enrollment.
• Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
• Any planned surgery during the study period.
• Subjects who have cancer disorders excluding nonmelanotic skin cancer.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (3)

Kempegowda Institute of Medical Sciences Hospital (KIMS)

Bangalore, Karnataka, 560070, India

Location

Mandya Institute of Medical Sciences

Mandya, Karnataka, 571401, India

Location

Padmashree Dr. D.Y Patil Hospital

Pune, MS, 411018, India

Location

Related Publications (1)

• Mahendra BJ, Narayana DA, Agarkhedkar S, Ravish HS, Harish BR, Agarkhedkar S, Madhusudana SN, Belludi A, Ahmed K, Jonnalagedda R, Vakil H, Bhusal C, Arora AK. Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen). Hum Vaccin Immunother. 2015;11(2):428-34. doi: 10.4161/21645515.2014.995059.

  PMID: 25692792 DERIVED

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 3, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 5, 2014
• Results First Posted: May 5, 2014

Record last verified: 2014-04

Locations

IN (3)