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CTRI Number  CTRI/2014/04/004538 [Registered on: 11/04/2014] Trial Registered Retrospectively
Last Modified On: 10/03/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized Factorial Trial 
Public Title of Study   Rabies G Protein Vaccine study for immunization against Rabies 
Scientific Title of Study   Safety and Immunogenicity Study of Rabies G Protein Vaccine Administered as a Simulated Post-exposure Immunization in Healthy Volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRSC12002 Ver 4.0 dated 02/09/13  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Sawhney 
Designation  Head BA/BE & CR 
Affiliation  CRO-Cadila Pharmaceuticals Ltd 
Address  1389, Trasad Road, Dholka, India
1389, Trasad Road, Dholka, India
Ahmadabad
GUJARAT
387810
India 
Phone  02714-221481  
Fax    
Email  deepak.sawhney@cadilapharma.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Sawhney 
Designation  Head BA/BE & CR 
Affiliation  CRO-Cadila Pharmaceuticals Ltd 
Address  1389, Trasad Road, Dholka, India
1389, Trasad Road, Dholka, India
Ahmadabad
GUJARAT
387810
India 
Phone  02714-221481  
Fax    
Email  deepak.sawhney@cadilapharma.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Sawhney 
Designation  Head BA/BE & CR 
Affiliation  CRO-Cadila Pharmaceuticals Ltd 
Address  1389, Trasad Road, Dholka, India
1389, Trasad Road, Dholka, India
Ahmadabad
GUJARAT
387810
India 
Phone  02714-221481  
Fax    
Email  deepak.sawhney@cadilapharma.co.in  
 
Source of Monetary or Material Support  
Cadila Pharmaceuticals Ltd. 
 
Primary Sponsor  
Name  Cadila Pharmaceuticals Limited 
Address  Corporate Campus, Sarkhej-Dholka Highway, Village: Bhat, Ahmedabad – 382210, Gujarat, India 
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 Moti Talpada  Apollo Hospitals International Limited  Dept. of infectious disease & internal medicine, Bhat, GIDC Estate, Gandhinagar – 382 428, Gujarat, India.
Gandhinagar
GUJARAT 		 079-66701800
079-66701843
mdtalpada2001@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Apollo hospitals international limited  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Rabies 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rabies G Protein Vaccine (10mcg)  0.5 ml Intramuscular Vaccine will be given of 10mcg of Rabies G Protein vaccine on day schedules 0,3 
Intervention  Rabies G Protein Vaccine (10mcg)  0.5 ml Intramuscular Vaccine will be given of 10mcg of Rabies G Protein vaccine on day schedules 0,3,7 
Intervention  Rabies G Protein Vaccine (10mcg)  0.5 ml Intramuscular Vaccine will be given of 10mcg of Rabies G Protein vaccine on day schedules 0,7 
Intervention  Rabies G Protein Vaccine (10mcg)  0.5 ml Intramuscular Vaccine will be given of 10mcg of Rabies G Protein vaccine on day schedules 0,7,10 
Intervention  Rabies G Protein Vaccine (20mcg)  0.5 ml Intramuscular Vaccine will be given of 20mcg of Rabies G Protein vaccine on day schedules 0,3 
Intervention  Rabies G Protein Vaccine (20mcg)  0.5 ml Intramuscular Vaccine will be given of 20mcg of Rabies G Protein vaccine on day schedules 0,3,7 
Intervention  Rabies G Protein Vaccine (20mcg)  0.5 ml Intramuscular Vaccine will be given of 20mcg of Rabies G Protein vaccine on day schedules 0,7 
Intervention  Rabies G Protein Vaccine (20mcg)  0.5 ml Intramuscular Vaccine will be given of 20mcg of Rabies G Protein vaccine on day schedules 0,7,10 
Intervention  Rabies G Protein Vaccine (50mcg)  0.5 ml Intramuscular Vaccine will be given of 50mcg of Rabies G Protein vaccine on day schedules 0,3 
Intervention  Rabies G Protein Vaccine (50mcg)  0.5 ml Intramuscular Vaccine will be given of 50mcg of Rabies G Protein vaccine on day schedules 0,3,7 
Intervention  Rabies G Protein Vaccine (50mcg)  0.5 ml Intramuscular Vaccine will be given of 50mcg of Rabies G Protein vaccine on day schedules 0,7 
Intervention  Rabies G Protein Vaccine (50mcg)  0.5 ml Intramuscular Vaccine will be given of 50mcg of Rabies G Protein vaccine on day schedules 0,7,10 
Intervention  Rabies G Protein Vaccine (5mcg  0.5 ml Intramuscular Vaccine will be given of 5mcg of Rabies G Protein vaccine on day schedules 0,7,10 
Intervention  Rabies G Protein Vaccine (5mcg)  0.5 ml Intramuscular Vaccine will be given of 5mcg of Rabies G Protein vaccine on day schedules 0,3 
Intervention  Rabies G Protein Vaccine (5mcg)  0.5 ml Intramuscular Vaccine will be given of 5mcg of Rabies G Protein vaccine on day schedules 0,3,7 
Intervention  Rabies G Protein Vaccine (5mcg)  0.5 ml Intramuscular Vaccine will be given of 5mcg of Rabies G Protein vaccine on day schedules 0,7 
Comparator Agent  Rabies vaccine (Rabipur)  Intramuscular injection will be given on the Day 0,3,7,14,28 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  - Healthy human volunteers of 18 to 65 years
- During the first stage-I of the study, only male volunteers will be recruited.
- Volunteers with seronegative status for anti-rabies antibodies at baseline
- Volunteers who are in good health at the time of entry into the study as determined by
medical history, physical examination and clinical judgment of the investigator
- Volunteers willing to comply with the requirements of protocol (volunteer for
simulated post-exposure immunization and, willing to be available for all study visits as
well blood drawing)
- Volunteer who has signed or Institutional Review Board (IRB) approved informed
consent form (ICF)
- Volunteer available by phone
- Documented negative test for human immuno virus (HIV-1/2), HBsAg or HCV
- Negative urine pregnancy test for female volunteer of child-bearing potential
- Female volunteer of child bearing potential or sexually active male volunteer with
partners of childbearing potential must practice acceptable barrier contraception (e.g.,
condoms, intrauterine contraceptive devices, or sterilization) during treatment and at
least 2 months after the last dose of vaccine. 
 
ExclusionCriteria 
Details  - History of potential rabies exposure or who has received rabies vaccination(active/passive)
-History of known hypersensitivity/allergy to egg proteins, animal cell product, insect
proteins or NP9 (The VLP vaccine to be used in this study does not contain egg
proteins, but comparators in randomized trials may) or any excipients of vaccine
formulation
- Who has received any other vaccines within 6 months prior to enrollment
- Body temperature ≥38.0°C (≥ 100.4° F) prior to first vaccination
- Volunteer with any acute infectious disease at the time of enrollment
- Volunteer with any chronic illness
- Administration of immunomodulating agents within six months prior to administration
of study medications
- Volunteers on concomitant antimalarials or treatment with an anti-malarial drug, up to
two months prior to the study
- History or currently consuming drugs of abuse or alcohol
- Volunteer with deficiency of IgG, IgM & IgA
- Volunteer with an abnormal clinical chemistry, hematology or urinalysis results that is
considered clinically significant by the investigator or the sponsor.
Pregnant or lactating female volunteer, or planning to become pregnant during the
projected duration of the clinical trial, or who cannot provide a credible history of
reliable contraceptive practices
- Participation in another clinical trial in the past 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
- Proportion of volunteers with solicited adverse events, unsolicited adverse events and
serious adverse events
- Proportion of volunteers with seroprotection levels
- Geometric mean titers of anti-rabies antibodies 		 0-42 days 
 
Secondary Outcome  
Outcome  TimePoints 
Safety & Immunogenicity  0-180 days 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   22/01/2014 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   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  

Cadila Pharmaceuticals Limited, India has successfully tested VLP-based Rabies G Protein Vaccine in preclinical models and to take the development further, it needs to be tested in humans. Present study is the FIH trial involving Rabies G Protein Vaccine to evaluate its safety and immunogenicity. When new rabies vaccines are introduced, their immunogenicity is evaluated by comparing the RABV neutralizing antibody titres induced by the vaccine being tested with those induced by a vaccine of demonstrated efficacy. As rabies is a fatal disease, randomized controlled human trials involving untreated comparison groups could not be carried out for ethical reasons.8 Lesser doses (2 or 3) of post-exposure prophylaxis might see savings to healthcare system and individuals in terms vaccine cost and additional medical visits, in addition to overall better treatment compliance. Based on our preclinical experience and above statements, we postulate that Rabies G Protein Vaccine will provide faster and similar seroprotection against rabies in comparison to worldwide approved Rabipur vaccine as a simulated post-exposure immunization in healthy volunteers.

 
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