CTRI/2019/06/019622 [Registered on: 11/06/2019] Trial Registered Prospectively
Last Modified On:
26/05/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Study to check safety of Rabishield and Rabivax-S vaccines in patients with animal bites by suspected rabid animals
Scientific Title of Study
A Phase IV, Randomized, Controlled Study of the Safety and Immunogenicity of Rabishield, Rabivax-S Post-exposure Prophylaxis regimen in Patients with Potential Rabies Exposure
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Rab - 04 (Protocol Ver 2.0 dated 14 Sep 2018)
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
B. J. Govemment Medical College and Sassoon General Hospitals. Pune
Agarkar Nagar, Jai Prakash Naral.an Road, Near Pune Railway Station, Pune, Maharashtra 411001 Pune MAHARASHTRA
9423007898
muralidhartambe@rediffmail.com
Dr Clarence J Samuel
Christian Medical College, Ludhiana
Department of Community Medicine, Christian Medical College, Brown road, Ludhiana 141008, India Ludhiana PUNJAB
9988099867
clarencejs@yahoo.com
Dr Avinash Gawande
Government Medical College & Hospital, Nagpur
Government Medical College & Hospital, Department of Community Medicine, Medical Square, Nagpur 440009, Maharashtra, India Nagpur MAHARASHTRA
9822224020
dravinashgawande@gmail.com
Dr Dinesh Kumar
Government Medical College, Jammu
Department of
Community Medicine,
Government Medical
College, Bakshi Nagar,
Jammu – 180001 Jammu JAMMU & KASHMIR
0191-2585635
dineshgmcjamcmcl@gmail.com
Dr Sushama Subhash Thakre
Indira Gandhi Govt. Medical College, Nagpur
Indira Gandhi Govt. Medical College, Central Avenue Road, Nagpur, Maharashtra 440015 Nagpur MAHARASHTRA
07122770929
sushamathakre@rediffmail.com
Dr Anupam Mandal
Institute of Post Graduate Medical Education & Research
Institute of Post Graduate Medical Education and Research
244, Acharya Jagdish Chandra Bose Road, Kolkata, 700020, Kolkata WEST BENGAL
9434120356
mandalanupam75@gmail.com
Dr Veena Kamath
Kasturba Medical College, Manipal,
Kasturba Hospital, Manipal Manipal Academy of Higher Education,
Madhav Nagar, Manipal,
576104, Karnataka Udupi KARNATAKA
0820-2922324
veenak@manipal.edu
Dr Ravish HS
Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre
Kempegowda Institute of Medical Sciences (KIMS) Hospital and Research Centre,K.R.Road, V.V. Puram,Bangalore - 560 004, India. Bangalore KARNATAKA
9900562743
drravishhs@rediffmail.com
Dr Sudhir Pawar
Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai
Department of Pharmacology,
2nd floor, College Building,
Lokmanya Tilak Municipal Medical College & General Hospital, Dr. Babasaheb Ambedkar Road, Sion Mumbai-400022 Mumbai MAHARASHTRA
Mandya Institute of Medical Sciences, Mandya 571401, Karnataka State Mandya KARNATAKA
9448444396
harishmims@gmail.com
Dr Anurag Agarwal
Maulana Azad Medical College & Associated Lok Nayak Hospital
Maulana Azad Medical College & Associated Lok Nayak Hospital,
Bahadur Shah Zafar Marg, New Delhi 110002, India New Delhi DELHI
9810409625
doctoranuragagarwal@gmail.com
Dr Kamlesh Kumar Jain
Pt. Jawahar Lal Nehru Memorial Medical College, Raipur
Pt. Jawahar Lal Nehru Memorial Medical College, Dr. Bhim Rao Ambedkar Memorial Hospital, Jail Road, Raipur, Chhattisgarh 492001. Raipur CHHATTISGARH
9425503176
dr.kamleshjain@gmail.com
Dr Kusum Lata Gaur
Sawai Man Singh Medical College, Jaipur
Sawai Man Singh Medical College, Jawahar Lal Nehru Marg, Jaipur, Rajasthan -302004 Jaipur RAJASTHAN
9460271172
drkusumgaur@gmail.com
Dr Nithya Gogtay
Seth G S Medical College and KEM Hospital
Dept. of Clinical
Pharmacology 1st
Floor, New M.S
Building, Seth G.S.M.C
and KEMH, Parel,
Mumbai, Maharashtra-400012 Mumbai MAHARASHTRA
022-24174420
njgogtay@hotmail.com
Dr Shahzada Mohmed Salim Khan
Shri Maharaja Hari Singh (SMHS), Hospital Government Medical College, Srinagar
Shri Maharaja Hari Singh (SMHS), Hospital Government Medical College, Srinagar-190010 Srinagar JAMMU & KASHMIR
01942503633
spmgmcsk@gmail.com
Dr Atul Kakar
Sir Ganga Ram Hospital, New Delhi
Department of Medicine, Sir Ganga Ram Hospital, Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi-110060, India New Delhi DELHI
98111110802
atulkakar@hotmail.com
Dr Saurabh Singhal
Subharti Medical College and Hospitals
Subharti Medical College and Hospitals, Subhartipuram, NH 58 Delhi-Haridwar Bypass road, Meerut-250005, Uttar Pradesh New Delhi DELHI
00919412578658
singhaldnb2007@yahoo.co.in
Dr Renuka Munshi
T N Medical College and BYL Nair Hospital
Department of Clinical Pharmacology, T N Medical
College and BYL Nair
Hospital Dr A L Nair
Road, Mumbai Central,
Mumbai, Maharashtra-400008 Mumbai MAHARASHTRA
9820377409
renuka.munshi@gmail.com
Dr Devang Rana
Vadilal Sarabhai General Hospital, Ahmedabad
Vadilal Sarabhai General Hospital, Near Ellisbridge, Paldi, Ahmedabad, Gujarat – 380006 Ahmadabad GUJARAT
Ethics Committee, IPGME & R Research Oversight Committee Institute of Postgraduate Medical education & Research,
Submittted/Under Review
Institutional Ethics Committee B J Medical College and Sasoon General Hospital Pune
Approved
Institutional Ethics Committee Government Medical College, Jammu
Submittted/Under Review
Institutional Ethics Committee Government Medical College, Nagpur
Approved
Institutional Ethics committee Kasturba Medical College Manipal
Approved
Institutional Ethics Committee Lokmanya Tilak Municipal Medical College and General Hospital
Approved
Institutional ethics committee Maulana Azad Medical College (MAMC)
Approved
Institutional Ethics Committee Pt. J N M Medical College Raipur
Approved
Institutional Ethics Committee, Christian Medical College, Ludhiana
Approved
Institutional ethics committee, Seth GS medical College and KEM hospital,
Approved
Institutional Ethics Committee, Subharti Medical College & Hospital,
Approved
Institutional Ethics Committee, Topiwala National Medical College & BYL Nair Ch. Hospital
Approved
Institutional Ethics Committee,Mandya Institute of Medical Sciences
Submittted/Under Review
KIMS Institutional Ethics Committee,Kempegowda Institute of Medical Sciences
Approved
Sir Ganga Ram Hospital, Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: A829||Rabies, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Equirab (Equine Rabies Immune Globulin)
The composition of Equirab (Rabies Antiserum I.P.) 1500 IU/ 5 mL vial is as below:
Each vial contains: Equine antirabies immunoglobulin fragments not less than 300 I.U./ml
Manufactured by Bharat Serums and Vaccines Limited, India.
Intervention
Rabishield and Rabivax-S
Rabishield:
Rabishield is supplied as 2.5 ml vials containing not less than 40 IU/ml.
Manufactured by Serum Institute of India Pvt. Ltd., Pune, India.
Rabivax-S:
Each dose of 1 mL contains:
Purified Rabies Antigen (Rabies virus Pitman-Moore Strain 3218-VERO adapted and grown on vero cells, inactivated by using ß- propiolactone) not less than 2.5 IU
Manufactured by Serum Institute of India Pvt Ltd, Pune, India.
Inclusion Criteria
Age From
2.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Patients aged more than 2 years of either sex
2. WHO Category III exposure(s) by a suspected rabid animal < 72 hours prior to enrollment and < 24 hours if exposure to face, neck, hand or fingers.
3. Written informed consent by subjects (≥18 years) / parents of subjects (2-17 years).
4. Written informed assent by subjects aged 7-17 years
ExclusionCriteria
Details
1. Previous receipt of complete PEP or pre-exposure prophylaxis with modern cell culture rabies vaccine.
2. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric,
cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination, which in the opinion of the investigator might interfere with the study objectives.
3. Major congenital defects or serious chronic illness.
4. History of thrombocytopenia or known bleeding disorders.
5. Receipt of other investigational study agent within previous 30 days or planned during the course of this study.
6. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant participating in the study or making it unlikely the subject could complete the protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Incidence of related serious adverse events (SAEs) through 365 days after Day 0 immunization
Through 365 days after Day 0 immunization
Secondary Outcome
Outcome
TimePoints
1. Incidence of all SAEs through 365 days after Day 0 immunization
2. Adverse events (AEs) through 3 days after last dose of PEP regimen
Incidence of all SAEs through 365 days after Day 0 immunization and adverse events (AEs) through 3 days after last dose of PEP regimen
Target Sample Size
Total Sample Size="4000" Sample Size from India="4000" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is an open label, phase IV, randomized, controlled study. Safety (in all participants) and immunogenicity (in a subset) of Rabishield + Rabivax-S and ERIG + Rabivax-S PEP regimen will be evaluated. Rabivax-S will be administered either by intramuscular (IM) route as per Essen PEP regimen or intradermal (ID) route as per Updated Thai Red Cross Schedule in patients with WHO category III exposures by suspected rabid animals as per randomization. Category III exposures include single or multiple transdermal bites or scratches, contamination of mucous membrane or broken skin with saliva from animal licks, and exposures due to direct contact with bats (severe exposure). All the participants will be followed up for 1 year for safety.