| 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
|
|
|
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
|
|
|
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)?
|
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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.
|