Health Condition 1: null- Potential Rabies exposure
Conditions
Interventions
Intervention1: SII RMAb: Human IgG1 monoclonal antibody directed to rabies G glycoprotein. SII RMAb will be supplied as 2.5 ml vials. The calculated dose will be administered directly in the wounds,
Sponsors
Serum Institute of India Ltd Pune India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged 5 years or more than 5 years (Initially 10 adults ) 2.WHO Category III exposure(s) by a suspected rabid animal 3.Written informed consent by subjects (18 years and more) / parents of subjects (5-17 years). 4.Written informed assent by subjects aged 7-17 years 5.Free of obvious health problems. 6.A woman of child bearing age must agree not to become pregnant and a man must agree not to father a child, until the completion of the study period by using appropriate contraceptive methods.
Exclusion criteria
Exclusion criteria: 1.Previous receipt of rabies immune globulin and /or rabies vaccine. 2.Chronic administration of immunosuppressants or other immune-modifying agents. 3.Acute febrile illness or acute infectious disease. 4.Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, which in the opinion of the investigator might interfere with the study objectives. 5.Major congenital defects or serious chronic illness. 6.History of thrombocytopenia or known bleeding disorders. 7.History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis. 8.Pregnant and lactating women. 9.Receipt of other investigational study agent within previous 30 days or planned during the course of this study. 10.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of Day 14 geometric mean concentrations of anti-rabies neutralizing antibodies of subjects receiving SII RMAb + RABIVAX® to subjects receiving HRIG + RABIVAX® .Timepoint: Ratio of Day 14 geometric mean concentrations of anti-rabies neutralizing antibodies of subjects receiving SII RMAb + RABIVAX® to subjects receiving HRIG + RABIVAX® . | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentrations of anti-rabies G glycoprotein antibodyTimepoint: Days 3, 7, 14, 28, 42 and 84;Incidence of SAEsTimepoint: during the study Participation;Incidence of solicited local and systemic reactionsTimepoint: up to Day 7;Incidence of unsolicited adverse eventsTimepoint: during the study Participation;Proportion of subjects with anti-drug antibody (ADA)Timepoint: Day 14 and Day 84;Proportion of subjects with RFFIT titres more than or equal to 0.5 IU/mlTimepoint: Days 3, 7, 14, 28, 42 and 84;Ratio of geometric mean concentrations of anti-rabies neutralizing antibodies of subjects receiving SII RMAb + RABIVAX® to subjects receiving HRIG + RABIVAX®Timepoint: Days 3, 7, 14, 28, 42 and 84 | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Ltd.
Outcome results
None listed