| CTRI Number |
CTRI/2016/08/007137 [Registered on: 02/08/2016] Trial Registered Prospectively |
| Last Modified On: |
07/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Immunogenicity and safety study of Rabies G protein Vaccine administered as a simulated post-exposure immunization in healthy volunteers |
|
Scientific Title of Study
|
Immunogenicity and safety study of Rabies G protein Vaccine administered as a simulated post-exposure immunization in healthy volunteers |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CRSC15001 Version 3 Dated 12 March 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maharshi Desai |
| Designation |
Principal Investigator |
| Affiliation |
Apollo Hospital International Limited |
| Address |
Apollo Hospital International Limited., Plot No. I A
Bhat GIDC Estate,
Gandhinagar
Gandhinagar
GUJARAT
382428
India |
| Phone |
919825677462 |
| Fax |
|
| Email |
ahmedabad@aherf-smo.org |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanjay Patel |
| Designation |
Manager |
| Affiliation |
CRO-Cadila Pharmaceuticals Limited |
| Address |
Cadila Pharmaceuticals Limited
1389, Trasad Road,
Dholka
Ahmadabad
GUJARAT
387810
India |
| Phone |
9825603307 |
| Fax |
|
| Email |
sanjay.p@cadilapharma.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sanjay Patel |
| Designation |
Manager |
| Affiliation |
CRO-Cadila Pharmaceuticals Limited |
| Address |
Cadila Pharmaceuticals Limited
1389, Trasad Road
Dholka
Ahmadabad
GUJARAT
387810
India |
| Phone |
9825603307 |
| Fax |
|
| Email |
sanjay.p@cadilapharma.co.in |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmaceuticals Limited |
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road, Dholka, Ahmedabad – 387810, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Ramasubramanian |
Apollo Hospitals |
Apollo Hospitals,
No. 21, Greams Lane, Off Greams Road, Chennai- 600006
Chennai
TAMIL NADU |
04428295045
idisdoc@gmail.com |
| Dr Maharshi Desai |
Apollo Hospitals International Ltd |
Apollo Hospitals International Ltd, Bhat, GIDC Estate, Gandhinagar- 382428
Gandhinagar
GUJARAT |
9825677462
ahmedabad@aherf-smo.org |
| Dr Akash Khobragade |
Grant Government Medical College & Sir JJ Group of Hospitals |
Department of Pharmacology, Byculla, Mumbai - 400008.
Mumbai
MAHARASHTRA |
919970067624
akash.khobragade@gmail.com |
| Dr Ravish H S |
Kempegowda Institute of Medical Science |
Kempegowda Institute of Medical Science,
Athibabbe road, Near BDA Complex, Banashankari 2nd Stage, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
919900562743
drravishhs@rediffmail.com |
| Dr Samir Malhotra |
Postgraduate Institute Of Medical Education And Research (PGIMER) |
Postgraduate Institute Of Medical Education And Research (PGIMER), Sector 12,Chandigarh 160012
Chandigarh
CHANDIGARH |
919417016343
smal.pgi@gmail.com |
| Dr Surendra Kumar |
S.P Medical College & A.G Hospitals |
S P Medical College Road, PBM Hospital, Bikaner 334001
Bikaner
RAJASTHAN |
9825677462
drsurendrakumar@rediffmail.com |
| Dr Monica Gupta |
Samvedna Hospital |
B27/88G, Ravindrapuri, Varanasi - 221005
Varanasi
UTTAR PRADESH |
918573027161
drmonuka.g@rediffmail.com |
| Dr Vinay Gajanand Bhomia |
Sanjivani Superspeciality Hospital Pvt. Ltd |
Sanjivani Superspeciality Hospital Pvt. Ltd,1, Uday park Society, Near Sunrise Park, Vastrapur, Ahmedabad-380015, Gujarat
Ahmadabad
GUJARAT |
919925047695
vgb.sanjivani@gmail.com |
| Dr Prakash Kurmi |
Shivam Hospital |
Shivam Hospital,
C-4, Satyanarayan Society, Jashodanagar cross road, Maninagar, Ahmedabad-380008,Gujarat
Ahmadabad
GUJARAT |
919925047695
Dr_prakashkurmi@yahoo.co.in |
| Dr Durga Madhab Satapathy |
Veer Surendra Sai Institute of Medical Sciences & research |
Ayurvihar, Burla, Sambalpur. Pin - 768017
Sambalpur
ORISSA |
919861084185
drdurgams@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee, S.P Medical College & A.G Hospitals, PBM Hospital, Bikaner |
Approved |
| Institutional Ethics Committee, Apollo Hospitals International Ltd, Gandhinagar, Gujarat |
Approved |
| Institutional Ethics Committee, Grant government medical college & JJ group of hospital, Byculla, Mumbai |
Approved |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education Research, Chandigarh |
Approved |
| Institutional Ethics Committee- Apollo Hospitals, Chennai |
Approved |
| Institutional Research & Ethics Committee, Veer Surendra Sai Institute of Medical Sciences & Research, Sambalpur, Odisha |
Approved |
| KIMS Institutional Ethics Committee, Kemegowda Institute of Medical Sciences, Bangalore |
Approved |
| Samvedna Hospital Ethics Committee, B 27/88 G, Ravindrapuri, Varanasi-221005 |
Approved |
| Sanjivani Hospital Ethics Committee 1, New Uday Park Soc., Nr. Sunrise Park, Vastrapur, Ahmedabad |
Approved |
| Shivam ethics committee, Institution Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Rabies G protein Vaccine (Dose: 50 μg/0.5 ml)
Intramuscular Injection once on Day 0, 3 and 7. |
Manufactured by Cadila Pharmaceuticals Limited, India |
| Comparator Agent |
Rabipur Vaccine (Dose: 2.5 IU/ml, One dose Intramuscularly on Day 0, 3, 7, 14 & 28 (5 dose) |
Manufactured by Novartis
Healthcare Private Limited, India |
|
|
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.
• Volunteers with seronegative status for Rabies Virus Neutralizing Antibody (RVNA) titers at screening (by ELISA method)
• 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 (willing to be available for all study visits as well blood drawing).
• Volunteer who has signed Institutional Review Board (IRB) approved informed consent form (ICF)
• Documented negative test for human immunodeficiency 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 receipt of 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.
• Receipt of any other vaccines within 1 month 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 anti-malarials or treatment with an anti-malarial drug, up to two months prior to the study.
• History or current use of drugs of abuse or alcohol.
• Volunteer with deficiency of IgG, IgM & IgA.
• Volunteer with abnormal clinical chemistry, hematology or urinalysis results that are 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
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjects with seroprotection at 14 days post 1st dose of study vaccine |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety by monitoring subjects with adverse events
Time frame 0 to 180 days
Subjects with seroprotection at day 42 post 1st dose of study vaccine
An exploratory analysis will be done to compare seroprotection rate at day 90 and 180
|
42,90 and 180 days |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
Final Enrollment numbers achieved (Total)= "800"
Final Enrollment numbers achieved (India)="800" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/08/2016 |
| 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="2"
Months="4"
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
|
This study is a randomized, Open labeled assessor
blind, Phase-III, parallel design comparative clinical trial. Objective of study is to assess safety and immunogenicity of Rabies G protein Vaccine
(investigational vaccine) 10 µg at Day 0, 3 versus marketed Rabipur vaccine
(comparator vaccine) 2.5 IU/ml, at Days 0, 3, 7, 14 & 28 to be administered
as a simulated post-exposure (PEP) immunization.
The sero-negative volunteers at screening (by ELISA method) will be randomized in a ratio of 2:1 to receive either test or comparator vaccine, respectively. Vaccination will be done in the deltoid muscle.On vaccination day, volunteers will remain at the hospital for a period of at least 6 hours for observation and assessment of local injection site reactions and the occurrence of any adverse events (AEs). The primary outcome
measures will be Subjects with
seroprotection at 14 days post 1st dose of study vaccine & the secondary
outcomes will be Subjects with seroprotection at day 42 post 1st dose of study
vaccine and Safety by monitoring subjects with adverse events [Time frame:
0-180 days]
Window period of ±2 days will be allowed for day 14 and day 42. An exploratory analysis will be done to compare seroprotection rate at day 90 & 180. Rabies Virus Neutralizing Antibody (RVNA) titers will be analyzed by rapid fluorescent focus inhibition test (RFFIT) for Immunogenicity results. Final Clinical Study Report will include data of safety & immunogenicity up to day 180 & will be submitted to DCGI for market authorization. Volunteer will be considered to have completed the study if they are followed through 180 days ±7 days after first vaccination. Additionally on day 365±14 post first vaccination, one additional blood sample will be obtained for immunogenicity analysis. Separate supplementary report will be prepared for safety & immunogenicity data up to day 365. |