Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in 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

Acknowledgments

We thank the trial participants and their caregivers for their participation and support. We thank the dedicated study staff at the participating hospitals for implementing the study and providing patient care. We also thank the DSMB members, Vimta Labs Ltd, and JSS Medical Research India Pvt Ltd for their contributions to the study.

Declaration of interests

The authors H Sharma, S Parekh, P Pujari, S Shewale, S Desai, H Rao, M Gautam, S Gairola, and U Shaligram are employees of Serum Institute of India Pvt. Ltd., Pune India. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Hitt J Sharma, Sameer Parekh, Pramod Pujari, and Sunil Shewale were involved in the conception and design, or analysis and interpretation of the data; the drafting of the paper. Anand Kawade, Mandyam Ravi, Jitendra Oswal, Saji James, N. Mahantashetti, Renuka Munshi, Apurba Ghosh, Venkateshwar Rao, Sundaram Balsubramaniam, P. Varughese, A. Somshekhar were the principal investigators for this trial and were involved in the analysis and interpretation of the data. Shivani Desai, Amy Sarah Ginsburg, Harish Rao, Manish Gautam, Sunil Gairola, and Umesh Shaligram contributed in revising the manuscript critically for intellectual content. All authors approved the submitted version to be published; and agreed to be accountable for all aspects of the work.

Ethical approval

The study was conducted in accordance with the International Conference on Harmonization – Good Clinical Practice (ICH-GCP) guidelines, the principles of Declaration of Helsinki, Drugs, and Cosmetics (First Amendment) Rules, 2013, 122-DAB, and New Drugs and Clinical trial Rules-2019, Ministry of Health and Family Welfare, Government of India. Permission to conduct this study was granted by the National Regulatory Authority of India, i.e., DCGI. All the 11 Institutional Ethical Committees (IECs) were duly registered with DCGI. The protocol, protocol amendments, and other relevant documents were submitted to the IEC by the investigator and reviewed and approved by the IEC before the study was initiated, at their respective sites.

Clinical Trial Registration

Trial is registered at the Clinical Trials Registry-India (CTRI/2018/06/014617)

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14760584.2023.2188942

Additional information

Funding

This study was funded by the Serum Institute of India Pvt. Ltd. Pune, India, and Global Health Investment Fund, USA.