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CTRI Number  CTRI/2012/12/003225 [Registered on: 17/12/2012] Trial Registered Prospectively
Last Modified On: 14/09/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   to evaluate the safety, tolerability and neutralizing activity of Rabimabs against rabies virus in healthy subjects 
Scientific Title of Study   A Randomized, double-blind, placebo controlled multicentric Phase I/II study to evaluate the safety, tolerability and neutralizing activity of Rabimabs (A murine anti-rabies monoclonal antibody cocktails)against rabies virus in healthy subjects  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Rabimabs 1001 Ver. 1.1 Dated 02/5/2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kevin Kumar Kansagra 
Designation  Scientist 
Affiliation  Zydus Research Centre 
Address  Zydus Research Centre, -- Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya Ahmadabad GUJARAT

Ahmadabad
GUJARAT
382213
India 
Phone  02717665555  
Fax  02717665355  
Email  kevinkumarkansagra@zyduscadila.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr R H Jani 
Designation  Sr V P  
Affiliation  Cadila Healthcare Limited 
Address  Zydus Cadila House, 2nd floor, Plot No.360,T.P.S. 5, Service road, Vile Parle (East) Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400057
India 
Phone  02226186052  
Fax  26151735  
Email  rhjani@zyduscadila.com  
 
Details of Contact Person
Public Query
 
Name  Dr R H Jani 
Designation  Sr V P  
Affiliation  Cadila Healthcare Limited 
Address  Zydus Cadila House, 2nd floor, Plot No.360,T.P.S. 5, Service road, Vile Parle (East) Mumbai MAHARASHTRA


MAHARASHTRA
400057
India 
Phone  02226186052  
Fax  26151735  
Email  rhjani@zyduscadila.com  
 
Source of Monetary or Material Support  
Zydus Research Centre 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya Cadila Healthcare Limited Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road Crossing Ahmadabad GUJARAT 
 
Primary Sponsor  
Name  Zydus Research Centre  
Address  396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya Cadila Healthcare Limited Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road Crossing Ahmadabad GUJARAT 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kevibkumar Kansagra  Zydus Research Centre  396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya Cadila Healthcare Limited Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road Crossing Ahmadabad
Ahmadabad
GUJARAT 
02717665555
02717665355
kevinkumarkansagra@zyduscadila.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee-Aditya,Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  to evaluate the safety, tolerability and neutralizing activity of Rabimabs against rabies virus in healthy subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Rabimab Vaccine  RABIMABS will be available in 300 IU/mL. Each vial will contain 10ml of the solution. RABIMABS is equipotent mixture of two M777-16-3 and MAb 62-71-3 in 1:1 ratio. RABIMABS binds to 2 different epitopes on the G-protein of the rabies virus envelope. One milliliter of Zydus rabies vaccine (Vaxirab) will be injected into the deltoid muscle (contra lateral to RABIMABS or placebo). Frequency-Single dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details 
1. Healthy male and female volunteers between 18 and 55 years of age
2. No previous treatment with rabies vaccine
3. Body Mass Index (BMI) between 20 and 25 kg/m2 
 
ExclusionCriteria 
Details  1. Pregnant women, women planning to become pregnant and breastfeeding women
2. History and/or family history of clinically significant immunodeficiency or auto-immune disease
3. History of allergy to proteins
4. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction A history of or currently active clinically significant cardiac (including clinically significant abnormalities on Electrocardiogram [ECG] according to Principal Investigator [PI]), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease
5. Abnormal hemoglobin, total WBC, RBC, platelets counts AST, ALT, serum bilirubin, creatinine, BUN, fasting plasma glucose,
6. Subject taking any medications
7. Prior history of active or passive rabies immunization
8. Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator
9. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
10. History of untreated dog bites.
11. Subjects with detectable Rabies Vaccine Neutralizing Antibodies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Safety and tolerability
2. Pharmacokinetics (PK) after Intra muscular dose administrations in healthy adult volunteers
3. Pharmacodynamic (PD) effect after Intra muscular dose administrations in healthy adult volunteers
 
day 0, and on days 1, 2, 3, 7, 14, 21, 28, and 42 following drug administration.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. RABIMABS (Part 1 )
2. RVNA of human origin (Part 1& 2)
3. Human anti-RABIMABS antibodies (Part 1& 2) 
day 0, and on days 1, 2, 3, 7, 14, 21, 28, and 42 following drug administration.
 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   17/12/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="12" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Rabies is an acute fatal encephalomyelitis and remains one of the most feared and dreadful zoonotic diseases in the world. According to WHO estimate, Rabies occurs in more than 150 countries and territories. More than 55000 people die off Rabies every year. 40% of people who are beaten by suspected rabid animals are children under 15 years of age. More than 3 billions live in areas in which the disease is an enzootic. Once the clinical signs and symptoms develop, Rabies is almost invariably fatal.The anti-rabies monoclonal antibody cocktail drug being developed at Zydus Research Center, Cadila Healthcare Ltd. is a unique combination of two murine anti-G monoclonal antibodies (MAbs) selected from a panel of five MAbs shortlisted by WHO from collaborating research centres around the world, that bind to two different epitopes on the G protein expressed on the surface of Rabies virus. From panels of anti-rabies Mabs available through its collaborating centers, WHO had initially selected a smaller panel of five murine anti-G MAbs on the basis of their ability to neutralise a broad range of rabies viruses and their heavy chain isotype, selected to be either IgG1 or IgG2a. From this shortlisted panel of WHO, Zydus selected two monoclonals primarily on the basis of their ability to bind two different epitopes on the G protein, and secondarily on the basis of the phenotypic stability of the clone, ability to grow in bioreactors, ability for scalability of the clone, expression levels of the clone etc.

This is an A Randomized, double-blind, placebo controlled multicentric Phase I/II study to evaluate the safety, tolerability and neutralizing activity of Rabimabs (A murine anti-rabies monoclonal antibody cocktails) against rabies virus in healthy subjects

The objectives are to  evaluate the safety, tolerability and neutralizing activity of Rabimabs (A murine anti-rabies monoclonal antibody cocktails) against rabies virus in healthy subjects.







 
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