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CTRI Number  CTRI/2012/05/002709 [Registered on: 31/05/2012] Trial Registered Prospectively
Last Modified On: 20/12/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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 
Scientific Title of Study   A Phase II/III, Randomized, Multi-centric, 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 Prophylaxis in Patients following Potential Rabies Exposure 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
Rab-02/10[Ver 7 dated 02 December 2013]  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Prasad Kulkarni  
Designation  Medical Director 
Affiliation  Serum Institute of India Ltd. 
Address  Serum Institute of India Ltd. 212/2, Hadapsar, Pune
Medical Director, Serum Institute of India Ltd. 212/2, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  020-26602384  
Fax  020-26993945  
Email  drpsk@seruminstitute.com  
 
Details of Contact Person
Public Query  
Name  Dr Prasad Kulkarni  
Designation  Medical Director 
Affiliation  Serum Institute of India Ltd. 
Address  Serum Institute of India Ltd. 212/2, Hadapsar, Pune
Medical Director, Serum Institute of India Ltd. 212/2, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  020-26602384  
Fax  020-26993945  
Email  drpsk@seruminstitute.com  
 
Source of Monetary or Material Support  
Serum Institute Of India Ltd, 212/2, Hadapsar, Pune-411028, India 
 
Primary Sponsor  
Name  Serum Institute of India Ltd Pune India 
Address  Serum Institute Of India Ltd, 212/2, Hadapsar, Pune-411028, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas Kshirsagar  B. J. Government Medical College and Sassoon General Hospital Station Road, Pune  B. J. Government Medical College and Sassoon General Hospital Station Road, Pune 411001, Maharashtra, India
Pune
MAHARASHTRA 		 9921648187

drvikasdrvikas@yahoo.co.in 
Dr Dinesh Kumar  Dept of Community Medicine, Government Medical College, Jammu  Dept of Community Medicine, Government Medical College, Bakshi Nagar, Jammu
Jammu
JAMMU & KASHMIR 		 91-191-2585635

dineshgmcjamcmcl@gmail.com 
Dr Ranjit Mankeshwar   Grant Medical College and Sir. J.J Group of Hospitals, Mumbai  Department of Preventive and Social Medicine, 3rd Floor , Post Graduate Building Near Gate No.12, Grant Medical College and Sir. J.J Group of Hospitals, Byculla, Mumbai - 400 008, Maharashtra India
Mumbai
MAHARASHTRA 		 9820021492

ranjit.mankeshwar@gmail.com 
Dr Sampath Gadey   Institute of Preventive Medicine, Hyderabad  Institute of Preventive Medicine,, Narayanguda, Hyderabad- 500143, India.
Hyderabad
ANDHRA PRADESH 		 9652200027

dr.gsampath11@gmail.com 
DrD H Ashwath Narayana   Kempegowda Institute of Medical Sciences, Bangalore   Department of Community Medicine, Kempegowda Institute of Medical Sciences, Bangalore -560070 Karnataka
Bangalore
KARNATAKA 		 08026712791

dhashwathnarayana@gmail.com 
Dr BJ Mahendra   Mandya Institute of Medical Science, Mandya  Department of Community Medicine, Mandya Institute of Medical Science Nehrunagar, Mandya- 571401, Karnataka, India
Mandya
KARNATAKA 		 9341234014

mahendrabj@gmail.com 
Dr Nithya Gogtay   Seth Gordhandas Sunderdas Medical College (GSMC) and King Edward Memorial (KEM) Hospital, Mumbai  Department of Clinical Pharmacology, Seth Gordhandas Sunderdas Medical College (GSMC) and King Edward Memorial (KEM) Hospital, Acharya Donde Marg, Parel, Mumbai-400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 9820495836

njgogtay@hotmail.com 
Dr Renuka Munshi  TN Medical College and BYL Nair Charitable Hospital, Mumbai   Dept of Clinical Pharmacology, TN Medical College and BYL Nair Charitable Hospital, Mumbai – 400 008.
Mumbai
MAHARASHTRA 		 02223050347

renuka.munshi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee For Research on Human Subjects for Dr Gogtay  Approved 
Institutional Ethics Commitee for Dr Kshirsagar  Approved 
Institutional Ethics Committe for Dr Munshi  Approved 
Institutional Ethics Committee for Dr Ashwath Naryana  Approved 
Institutional Ethics Committee for Dr B J Mahendra  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Potential Rabies exposure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Human Rabies Immunoglobulin (HRIG)  Human rabies immunoglobulin USP, heat-treated, Imogam® is a sterile solution of antirabies immunoglobulin (10-18% protein). It is manufactured by Aventis. Imogam® will be supplied in 2 and 10 ml vials.The calculated dose will be administered directly in the wounds, as much as anatomically feasible. Any remaining volume will be administered by intramuscular route. Imogam will be administered only on Day 0 
Intervention  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, as much as anatomically feasible. Any remaining volume will be administered by intramuscular route. SII RMAb will be administered only on Day 0.  
 
Inclusion Criteria
Modification(s)  
Age From  5.00 Year(s)
Age To  99.99 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence
Modification(s)  		 Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
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
Modification(s)  
Outcome  TimePoints 
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 
Geometric mean concentrations of anti-rabies G glycoprotein antibody   Days 3, 7, 14, 28, 42 and 84  
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 
Proportion of subjects with anti-drug antibody (ADA)   Day 14 and Day 84 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   04/06/2012 
Date of Study Completion (India) 18/03/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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.  
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