Health Condition 1: Z291- Encounter for prophylactic immunotherapy
Conditions
Interventions
Intervention1: VaxiRab N : Pre-exposure prophylaxis (PrEP): PrEP consists of a series of 3 doses of 1 ml each administered IM day 0 (visit 1), day 7 (visit 3) and day 28 (visit 5). The vaccine should
Sponsors
Zydus Lifesciences Limited
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects for pre-exposure prophylaxis or subjects with WHO category II or III animal bites for post-exposure prophylaxis against rabies 2. Written informed consent and assent (if applicable) from adult subjects or parents of minor subjects (less than 18 years) 3. Participants or parents of participants with adequate literacy to fill the diary. Category II - nibbling of uncovered skin, minor scratches or abrasions without bleeding, licks on broken skin Category III single or multiple transdermal bites or scratches, contamination of mucous membrane with saliva from licks; exposure to bat bites or scratches
Exclusion criteria
Exclusion criteria: 1. History of anaphylaxis or serious reactions to other vaccines 2. History of suturing of the wound or application of irritants at the wound site 3. Participants with any clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, or immunological disorder 4. History of any serious chronic illness or immunosuppression (immunosuppressive illness or therapy) or on steroids 5. Subjects with any acute febrile illness (body temperature greater than or equals to 37.5 C) at the time of enrolment 6. Pregnant or lactating women or planning to become pregnant in the next one year 7. Participation in any clinical trial in the last 3 months 8. Patient with history of drug or alcohol abuse 9. Received any type of rabies vaccine or any dose of rabies immunoglobulin in the past 10. Treated with antimalarial drugs in last 2 months 11. Received blood, blood products, or immunoglobulins during the preceding 3 months 12. Any other vaccine administration within 30 days of initiation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety profile of VaxiRab N administered for prophylaxis against rabiesTimepoint: Week 1, Week 2, Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the immunogenicity of VaxiRab N in a subset of 10 percent of subjects Timepoint: 1. Proportion of participants who achieve antibody titre greater than or equals to 0.5 IU/mL on day 0, at week 2 and at week 4. 2. Geometric mean titre of rabies virus neutralizing antibodies on day 0, at week 2 and at week 4. | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed