Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India
Sharma Hitt J a Parekh Sameer a Pujari Pramod a Shewale Sunil a Desai Shivani a Kawade Anand b Ravi Mandyam c Oswal Jitendra d James Saji e Mahantashetti N. f Munshi Renuka g Ghosh Apurba h Rao Venkateshwar i Balsubramaniam Sundaram j Varughese P. k Somshekhar A. l Ginsburg Amy Sarah m Rao Harish n Gautam Manish o Gairola Sunil o Shaligram Umesh n
aDepartment of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd, Pune, India
bDepartment of Pediatrics, KEM Hospital Research Centre, Vadu Rural Health Program, Pune, India
cDepartment of Pediatrics, JSS Hospital, Mysore, India
dDepartment of Pediatrics, Bharti Vidyapeeth Deemed University Medical College and Hospital, Pune, India
eDepartment of Pediatrics, Sri Ramchandra Institute of Higher Education and Research, Chennai, India
fDepartment of Pediatrics, KLE's Dr. Prabhakar Kore Hospital, Belgavi, India
gDepartment of Clinical Pharmacology, Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital, Mumbai, India
hDepartment of Pediatrics, Institute of Child Health, Kolkata, India
iDepartment of Medicine, Global Gleneagles Hospitals, Hyderabad, India
jDepartment of Pediatrics, Kanchi Kamakoti Childs Trust Hospital, Chennai, India
kDepartment of Pediatrics, Christian Medical College, Ludhiana, India
lDepartment of Pediatrics, M. S. Ramaiah Medical College & Hos, Bengaluru, India
mConsulting Department, IMG Consulting, LLC, Seattle, WA, USA
nProduction Department, Serum Institute of India Pvt Ltd, Pune, India
oDepartment of Quality Control, Serum Institute of India Pvt Ltd, Pune, India
CONTACT Hitt J Sharma mailto:drhjs@seruminstitute.com Additional Medical Director, Serum Institute of India Pvt Ltd, Hadapsar, Pune 411028, India
Abstract
Background This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap).
Research Design and Methods In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4–65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment.
Results No significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination.
Conclusions Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated.
Keywords: Acellular pertussis, booster, diphtheria, tetanus, vaccine.
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