PMID- 37492421
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230727
IS  - 2772-3682 (Electronic)
IS  - 2772-3682 (Linking)
VI  - 14
DP  - 2023 Jul
TI  - Active safety surveillance of rabies monoclonal antibody and rabies vaccine in 
      patients with category III potential rabies exposure.
PG  - 100207
LID - 10.1016/j.lansea.2023.100207 [doi]
LID - 100207
AB  - BACKGROUND: A vero cell-based inactivated Rabies Vaccine (Rabivax-S) and Rabies 
      Human Monoclonal Antibody (Rabishield) have been approved since 2016. A 
      post-marketing surveillance was conducted in India from 2020 to 2021 to gather 
      real world safety data on Rabivax-S and Rabishield. METHODS: This was 
      non-interventional active surveillance in patients with category III potential 
      rabies exposure who were administered a post-exposure prophylaxis (PEP) regimen 
      (Rabishield and Rabivax-S) by their healthcare providers (HCPs) as per the 
      dosages and regimens mentioned in the package insert approved by the Indian 
      regulators. The approved schedule for PEP was local infiltration of Rabishield on 
      Day 0 and five doses of Rabivax-S on Day 0, 3, 7, 14, and 28 (Intramuscular 
      route, IM) or four doses of Rabivax-S on Day 0, 3, 7, and 28 (Intradermal route, 
      ID). The primary objective of this surveillance was to generate real-world 
      evidence on the safety and tolerability of Rabishield and Rabivax-S. All patients 
      enrolled in the surveillance were required to report any adverse events (AEs) 
      occurring up to Day 31 after initiation of PEP (administration of Rabishield and 
      the first dose of Rabivax-S) to their HCP. FINDINGS: A total of 1000 patients 
      with category III potential rabies exposure were enrolled across India. 991 
      patients received the PEP regimen with IM Rabivax-S while 9 received a PEP 
      regimen with the ID regimen. While 32% of the patients were <12 years of age, 
      11.8% were >/=12 to <18 years of age and 56.2% were >/=18 years of age. The entire 
      PEP regimen was completed by 97.3% of the enrolled patients. A total of 69 AEs 
      were reported in 64 patients. Out of these, 49 AEs in 47 patients were assessed 
      as causally related to the study products (26 with Rabishield and 23 with 
      Rabivax-S). The majority of the AEs were mild and all recovered without any 
      sequelae. One serious adverse event (SAE) of fracture of the hand was reported 
      which was not related to either Rabishield or Rabivax-S. No case of rabies was 
      reported. INTERPRETATION: Rabishield and Rabivax-S have an excellent safety 
      profile and are well tolerated. No participant developed rabies during 31 day 
      follow up. FUNDING: The PMS was funded by Serum institute of India Private 
      Limited which is the manufacturer of the study products.
CI  - (c) 2023 The Author(s).
FAU - Kang, Gagandeep
AU  - Kang G
AD  - Translational Health Science and Technology Institute, Faridabad, India.
FAU - Lakhkar, Anand
AU  - Lakhkar A
AD  - Serum Institute of India Pvt Ltd, Pune, India.
FAU - Bhamare, Chetanraj
AU  - Bhamare C
AD  - Serum Institute of India Pvt Ltd, Pune, India.
FAU - Dharmadhikari, Abhijeet
AU  - Dharmadhikari A
AD  - Serum Institute of India Pvt Ltd, Pune, India.
FAU - Narwadkar, Jyoti
AU  - Narwadkar J
AD  - Serum Institute of India Pvt Ltd, Pune, India.
FAU - Kanujia, Arti
AU  - Kanujia A
AD  - LabCorp Scientific Services & Solutions Pvt Ltd, Mumbai, India.
FAU - Kapse, Dhananjay
AU  - Kapse D
AD  - Serum Institute of India Pvt Ltd, Pune, India.
FAU - Gunale, Bhagwat
AU  - Gunale B
AD  - Serum Institute of India Pvt Ltd, Pune, India.
FAU - Poonawalla, Cyrus S
AU  - Poonawalla CS
AD  - Serum Institute of India Pvt Ltd, Pune, India.
FAU - Kulkarni, Prasad S
AU  - Kulkarni PS
AD  - Serum Institute of India Pvt Ltd, Pune, India.
LA  - eng
PT  - Journal Article
DEP - 20230516
PL  - England
TA  - Lancet Reg Health Southeast Asia
JT  - The Lancet regional health. Southeast Asia
JID - 9918419282806676
PMC - PMC10363514
OTO - NOTNLM
OT  - Post-marketing surveillance
OT  - Rabies human monoclonal antibody
OT  - Rabies vaccine
OT  - Safety
COIS- AL, CB, AD, JN, DK, BG and PSK are employees of SIIPL, which manufactures 
      Rabishield and Rabivax-S. CSP is the Chairman and Managing Director of SIIPL. The 
      principal investigator, GK served in an honorary capacity. All other authors 
      declare no competing interests. The study was funded by SIIPL which is the 
      manufacturer of the study vaccine. However, SIIPL did not provide the Rabishield 
      and Rabivax-S free of cost to the investigators. The investigators were paid a 
      fee per participant.
EDAT- 2023/07/26 06:43
MHDA- 2023/07/26 06:44
PMCR- 2023/05/16
CRDT- 2023/07/26 03:50
PHST- 2023/01/30 00:00 [received]
PHST- 2023/03/31 00:00 [revised]
PHST- 2023/04/24 00:00 [accepted]
PHST- 2023/07/26 06:44 [medline]
PHST- 2023/07/26 06:43 [pubmed]
PHST- 2023/07/26 03:50 [entrez]
PHST- 2023/05/16 00:00 [pmc-release]
AID - S2772-3682(23)00067-7 [pii]
AID - 100207 [pii]
AID - 10.1016/j.lansea.2023.100207 [doi]
PST - epublish
SO  - Lancet Reg Health Southeast Asia. 2023 May 16;14:100207. doi: 
      10.1016/j.lansea.2023.100207. eCollection 2023 Jul.