Comparing the level of protection induced by giving two different vaccination schedules for dog bites among healthy volunteers in India. A multi Centre study

Immunogenicity of rabies vaccine using an abridged Cambodia regimen and updated Thai Red Cross regimen in healthy volunteers in India: A parallel multicentric randomised open label trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058418

Enrollment

400

Registered

2023-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Purified Verocell Rabies Vaccine (Rabivax-s) / Purified Chick Embryo Cell Vaccine (ChiroRab): Abridged Cambodia regimen of either of two vaccines (Purified Verocell Rabies Vaccine / Pur

Eligibility

Inclusion criteria

Inclusion criteria: a) Healthy males or females b) Aged between 18 to 45 years c) Willing to give blood samples on days 0,14,28,42,180 and 365

Exclusion criteria

Exclusion criteria: a) History of dog bite b) History of rabies immunization c) Anti-malarial drug treatment during the last two months d) Treatment with parenteral or oral steroids / immunosuppressive drugs during the last two months e) Receiving immunoglobulins f) Suffering from an autoimmune disease or any other immunological disorder g) History of hypersensitivity to any vaccine h) History of drug abuse or alcohol abuse i) Psychological condition rendering the volunteer unable to understand the nature, scope, and consequence of the study j) Participation in other investigational trials at the same time k) Pregnant women and lactating mothers

Design outcomes

Primary

Measure	Time frame
The Primary outcome measure will be geometric mean titres of Rabies Virus Neutralizing Antibody on Day 42 from the start of the vaccination scheduleTimepoint: On Day 42 from the start of the vaccination schedule	—

Secondary

Measure	Time frame
Geometric mean titres of Rabies Virus Neutralizing Antibody ConcentrationsTimepoint: on Day Days 14, 28, 180 & 365 from start of the vaccination schedule;Safety outcome measures will comprise of solicited post-vaccination reactions, vaccine-related SAEs, & unsolicited vaccine-related AEsTimepoint: pre-defined time points from vaccination till 4 weeks after last vaccine dose.;Seroconversion rates (Rabies Virus Neutralizing Antibody Concentrations Equal & Above 0.5 IU/ml)Timepoint: on Days 14, 28, 42, 180 & 365 from the start of the vaccine schedule	—

Measure

Time frame

Geometric mean titres of Rabies Virus Neutralizing Antibody ConcentrationsTimepoint: on Day Days 14, 28, 180 & 365 from start of the vaccination schedule;Safety outcome measures will comprise of solicited post-vaccination reactions, vaccine-related SAEs, & unsolicited vaccine-related AEsTimepoint: pre-defined time points from vaccination till 4 weeks after last vaccine dose.;Seroconversion rates (Rabies Virus Neutralizing Antibody Concentrations Equal & Above 0.5 IU/ml)Timepoint: on Days 14, 28, 42, 180 & 365 from the start of the vaccine schedule

—

Countries

India

Contacts

Public ContactDr Jeromie Wesley Vivian Thangaraj

Indian Council of Medical Research -National Institute of Epidemiology

stanjeromie@nieicmr.org.in9756183000

Outcome results