Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India
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...
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| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | Expert Review of Vaccines |
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| Online Access: | http://dx.doi.org/10.1080/14760584.2023.2188942 |
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| author | Hitt J Sharma Sameer Parekh Pramod Pujari Sunil Shewale Shivani Desai Anand Kawade Mandyam Ravi Jitendra Oswal Saji James N. Mahantashetti Renuka Munshi Apurba Ghosh Venkateshwar Rao Sundaram Balsubramaniam P. Varughese A. Somshekhar Amy Sarah Ginsburg Harish Rao Manish Gautam Sunil Gairola Umesh Shaligram |
| author_facet | Hitt J Sharma Sameer Parekh Pramod Pujari Sunil Shewale Shivani Desai Anand Kawade Mandyam Ravi Jitendra Oswal Saji James N. Mahantashetti Renuka Munshi Apurba Ghosh Venkateshwar Rao Sundaram Balsubramaniam P. Varughese A. Somshekhar Amy Sarah Ginsburg Harish Rao Manish Gautam Sunil Gairola Umesh Shaligram |
| author_sort | Hitt J Sharma |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T23:29:18Z |
| format | Article |
| id | doaj.art-e0cedde7b1a44c5e8540564550c33c7a |
| institution | Directory Open Access Journal |
| issn | 1476-0584 1744-8395 |
| language | English |
| last_indexed | 2024-03-11T23:29:18Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Expert Review of Vaccines |
| spelling | doaj.art-e0cedde7b1a44c5e8540564550c33c7a2023-09-20T10:33:43ZengTaylor & Francis GroupExpert Review of Vaccines1476-05841744-83952023-12-0122127828710.1080/14760584.2023.21889422188942Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in IndiaHitt J Sharma0Sameer Parekh1Pramod Pujari2Sunil Shewale3Shivani Desai4Anand Kawade5Mandyam Ravi6Jitendra Oswal7Saji James8N. Mahantashetti9Renuka Munshi10Apurba Ghosh11Venkateshwar Rao12Sundaram Balsubramaniam13P. Varughese14A. Somshekhar15Amy Sarah Ginsburg16Harish Rao17Manish Gautam18Sunil Gairola19Umesh Shaligram20Serum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdKEM Hospital Research Centre, Vadu Rural Health ProgramJSS HospitalBharti Vidyapeeth Deemed University Medical College and HospitalSri Ramchandra Institute of Higher Education and ResearchKLE’s Dr. Prabhakar Kore HospitalTopiwala National Medical College and Bai Yamunabai Laxman Nair Charitable HospitalInstitute of Child HealthGlobal Gleneagles HospitalsKanchi Kamakoti Childs Trust HospitalChristian Medical CollegeM. S. Ramaiah Medical College & HosIMG Consulting, LLCSerum Institute of India Pvt LtdSerum Institute of India Pvt LtdSerum Institute of India Pvt LtdSerum Institute of India Pvt LtdBackground 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.http://dx.doi.org/10.1080/14760584.2023.2188942acellular pertussisboosterdiphtheriatetanusvaccine |
| spellingShingle | Hitt J Sharma Sameer Parekh Pramod Pujari Sunil Shewale Shivani Desai Anand Kawade Mandyam Ravi Jitendra Oswal Saji James N. Mahantashetti Renuka Munshi Apurba Ghosh Venkateshwar Rao Sundaram Balsubramaniam P. Varughese A. Somshekhar Amy Sarah Ginsburg Harish Rao Manish Gautam Sunil Gairola Umesh Shaligram Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India Expert Review of Vaccines acellular pertussis booster diphtheria tetanus vaccine |
| title | Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India |
| title_full | Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India |
| title_fullStr | Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India |
| title_full_unstemmed | Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India |
| title_short | Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India |
| title_sort | safety and immunogenicity of an indigenously developed tetanus toxoid diphtheria toxoid and acellular pertussis vaccine tdap in adults adolescents and children in india |
| topic | acellular pertussis booster diphtheria tetanus vaccine |
| url | http://dx.doi.org/10.1080/14760584.2023.2188942 |
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