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

Primary Purpose

Rabies

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Purified Chick Embryo Cell Inactivated Rabies Vaccine

About this trial

This is an interventional prevention trial for Rabies focused on measuring Rabies, rabies vaccines, post-exposure prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Kempegowda Institute of Medical Sciences Hospital (KIMS)
Mandya Institute of Medical Sciences
Padmashree Dr. D.Y Patil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A-Zagreb

Group B-Essen

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

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

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

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)

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.

Full Information

NCT ID

NCT01365494

First Posted

May 30, 2011

Last Updated

April 3, 2014

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT01365494

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rabies

Keywords

Rabies, rabies vaccines, post-exposure prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A-Zagreb

Arm Type

Active Comparator

Arm Description

Arm Title

Group B-Essen

Arm Type

Active Comparator

Arm Description

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)

Intervention Type

Biological

Intervention Name(s)

Purified Chick Embryo Cell Inactivated Rabies Vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

On Day 0 and Day 14

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Study day 7, 14 and 42

Title

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

Description

Time Frame

Day 0, Day 7, Day 14 and Day 42

Title

Percentages of Subjects Reporting Adverse Events (AEs)

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines and Diagnostics

Organizational Affiliation

Novartis

Official's Role

Study Director

Facility Information:

Facility Name

Kempegowda Institute of Medical Sciences Hospital (KIMS)

City

Bangalore

State/Province

ZIP/Postal Code

560070

Country

India

Facility Name

Mandya Institute of Medical Sciences

City

Mandya

State/Province

ZIP/Postal Code

571401

Country

India

Facility Name

Padmashree Dr. D.Y Patil Hospital

City

Pune

State/Province

ZIP/Postal Code

411018

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

25692792

Citation

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.

Results Reference

derived

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

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