A comparison of safety and immunogenicity between government of India approved Rabies pre exposure prophylaxis regimen and WHO Rabies pre exposure prophylaxis regimen

A randomized controlled trial on Safety and Immunogenicity of purified verocell rabies vaccine as pre-exposure prophylaxis via Intradermal two visits (2-0-2-0-0) verses three visits (1-0-1-0-1) regimen on healthy volunteers - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057399

Enrollment

100

Registered

2023-09-11

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: Pre Exposure Prophylaxis for Rabies: WHO recommended PrEP Vaccination Schedule, 2 doses 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 Control Intervention1: Pre Exposure Prophylaxi

Eligibility

Inclusion criteria

Inclusion criteria: •Healthy subjects willing to volunteer and sign written informed consent for the study. •Subjects should be available for the follow-up period.

Exclusion criteria

Exclusion criteria: ?Received Anti rabies vaccine or RIG or RMAb anytime in the past. ?Participation in any other clinical trial in the past three months. ?Severely immunocompromised subjects, pregnant and lactating women. Subjects with known history of allergy.

Design outcomes

Primary

Measure	Time frame
To assess the seroconversion (= 0.5 IU/mL) of the study subjects following primary & boosting vaccination on Day 35 ,Day 365, Day 372/375.Timepoint: Blood samples will be collected on Day 0, Day 35, Day 365, Day 372 and Day 375	—

Secondary

Measure	Time frame
To assess the incidence of adverse events(immediate/delayed, local/systemic) among subjects.Timepoint: On Day 0, Day 7, Day 28, Day 365, Day 368 &	—

Countries

India

Contacts

Public ContactDr Deekshith J Reddy

Kempegowda Institute of Medical Sciences

ramesh.masthi@gmail.com9845759992

Outcome results