A clinical trial to assess the safety and rabies antibody levels in blood following a new Human Monoclonal Antibody to Rabies (SII RMab) in comparison with Human Rabies Immune Globulin, when given together with Rabies Vaccine (RABIVAX®) in healthy adults.

Phase 1

Completed

• Conditions: Health Condition 1: null- Prevention of rabies

• Registration Number: CTRI/2009/091/000465
• Lead Sponsor: Serum Institute of India Ltd Pune India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1. Be > or equal 18 years of age and < or equal to 50 years of age and of either sex

2. Free of obvious health problems as established by medical history and screening evaluations including clinical examination

3. Non-smoker for at least 6 months

4.A woman must agree not to become pregnant and a man must agree not to conceive a child from the time of study enrollment until at least 1 year for women and three months for men after the completion of the injections.

5. Screening laboratory values must be in normal range.

Exclusion Criteria

1. Previous receipt of monoclonal antibody (whether licensed or investigational).

2.Previous receipt of rabies immune globulin and /or rabies vaccine.

3.History of potential rabies exposure.

4.Chronic administration of immunosuppressants or other immune- modifying agents within six months prior to administration of study medications.

5.Acute febrile illness or acute infectious disease.

6.Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives

7. Thrombocytopenia or known bleeding disorders

8. History of a previous severe allergic reaction. 9. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen

10.Positive urine pregnancy test during screening or within 24 hours of day 0 injection, or an unwillingness to undergo pregnancy testing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of the investigational productTimepoint: Day 0 through day 365.

Secondary Outcome Measures

Name	Time	Method
Serum concentrations and neutralizing activity of antibodies to rabies.Timepoint: Day 0 through day 365.