A Comparator-controlled Study of the Safety and Neutralizing Activity of a Human Monoclonal Antibody to Rabies (SII RMAb) Administered in Conjunction with Rabies Vaccine for Post-exposure rabies Prophylaxis

Phase 2/3

Completed

• Conditions: Potential Rabies exposure

• Registration Number: CTRI/2012/05/002709
• Lead Sponsor: Serum Institute of India Ltd Pune India

Brief Summary

This will be a single-blind, randomized, and comparator-controlled clinical study. Safety and neutralizing activity of SII RMAb will be compared to licensed HRIG when administered with RABIVAX® according to WHO recommended PEP regimen.

The study will be conducted in two parts. In Part 1, 50 patients with low risk Category III wounds only will be randomized. Enrollment will initially be restricted to adults.  An interim analysis of safety data from the first 10 adults through day 14 will be presented to the DCGI for review and permission to enroll children will be sought. Enrollment of adult males/ post menopausal females in the study will continue during this time.  Enrollment of children equal to or more than 5 years old, however, will begin only after permission from the DCGI has been received.  Based on an interim analysis for futility for Day 14 anti-rabies neutralizing antibody titers, by an independent Data Safety and Monitoring Board (DSMB), study will be continued. Part 2 of the study will consist of 150 patients with all types of Category III wounds.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-06
• Study Completion: 2015-03-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ratio of Day 14 geometric mean concentrations of anti-rabies neutralizing antibodies of subjects receiving SII RMAb + RABIVAX® to subjects receiving HRIG + RABIVAX® .	Ratio of Day 14 geometric mean concentrations of anti-rabies neutralizing antibodies of subjects receiving SII RMAb + RABIVAX® to subjects receiving HRIG + RABIVAX® .

Secondary Outcome Measures

Name	Time	Method
Incidence of solicited local and systemic reactions	up to Day 7
Incidence of unsolicited adverse events	during the study Participation
Incidence of SAEs	during the study Participation
Geometric mean concentrations of anti-rabies G glycoprotein antibody	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®	Days 3, 7, 14, 28, 42 and 84
Proportion of subjects with RFFIT titres more than or equal to 0.5 IU/ml	Days 3, 7, 14, 28, 42 and 84
Proportion of subjects with anti-drug antibody (ADA)	Day 14 and Day 84

Trial Locations

Locations (8)

B. J. Government Medical College and Sassoon General Hospital Station Road, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Dept of Community Medicine, Government Medical College, Jammu; 🇮🇳 JAMMU, & KASHMIR, India

Grant Medical College and Sir. J.J Group of Hospitals, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Institute of Preventive Medicine, Hyderabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Kempegowda Institute of Medical Sciences, Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Mandya Institute of Medical Science, Mandya; 🇮🇳 Mandya, KARNATAKA, India

Seth Gordhandas Sunderdas Medical College (GSMC) and King Edward Memorial (KEM) Hospital, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

TN Medical College and BYL Nair Charitable Hospital, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

B. J. Government Medical College and Sassoon General Hospital Station Road, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Vikas Kshirsagar

Principal investigator

9921648187

drvikasdrvikas@yahoo.co.in