A Phase II/III multicenter randomized single blind non-inferiority immunogenicity and safety study of TeddyVac™ vaccine of Human Biologicals Institute in healthy subjects of 10 years to 60 years of age

Sai Krishna Susarla; Manish Narang; Prashant Namdev Khandgave; Lipilekha Patnaik; Vasudev Rajapantula; Satish M; Rajashakar Bc; Devi Prasad Sahoo; Anand Kumar Kanakasapapathy

doi:10.1080/23744235.2024.2410466

A Phase II/III multicenter randomized single blind non-inferiority immunogenicity and safety study of TeddyVac™ vaccine of Human Biologicals Institute in healthy subjects of 10 years to 60 years of age

Infect Dis (Lond). 2024 Oct 8:1-15. doi: 10.1080/23744235.2024.2410466. Online ahead of print.

Authors

Sai Krishna Susarla¹, Manish Narang², Prashant Namdev Khandgave³, Lipilekha Patnaik⁴, Vasudev Rajapantula⁵, Satish M¹, Rajashakar Bc¹, Devi Prasad Sahoo¹, Anand Kumar Kanakasapapathy¹

Affiliations

¹ Human Biologicals Institute (A Division of Indian Immunologicals Limited), Hyderabad, India.
² Department of Pediatrics, Guru Teg Bahadur Hospital, Delhi, India.
³ Department of Pediatrics, Pulse Multispecialty Hospital, Pune, India.
⁴ Department of Community Medicine, IMS & SUM Hospital, Siksha 'O' Anusandhan deemed to be University, Bhubaneswar, India.
⁵ Department of Medicine, King George Hospital, Visakhapatnam, India.

PMID: 39378070
DOI: 10.1080/23744235.2024.2410466

Abstract

Background: WHO and other health agencies recommend that tetanus toxoid (TT) should be replaced by tetanus-diphtheria (Td) vaccine taking into consideration the low coverage and waning immunity, especially for diphtheria. In this randomised, multicentre, non-inferiority study, the immunogenicity and safety of TeddyVac^™ vaccine of Human Biologicals Institute were compared with an existing brand.

Methods: The study involved 444 eligible subjects in two age groups at four centres across India. Group A included subjects of 18-60 years and Group B subjects of 10-18 years of age. All subjects received single dose of either TeddyVac^™ or the comparator vaccine as per randomisation. Blood samples for antibody titre estimation were collected before vaccination and 4-6 weeks after vaccination. Immunogenicity was assessed by estimating seroconversion rate, seroprotection rate, and geometric mean titres of antibodies. Safety was evaluated by collection and analysis of data on solicited and unsolicited adverse events.

Results: Overall, 441 subjects completed the study. Both the vaccine arms showed comparable seroconversion after a single dose for both the components. Both arms showed increase in seroprotection and geometric mean titres after a single dose of vaccination for both vaccine components, being significantly better for the diphtheria component in the test vaccine arm. Only few minor local and systemic adverse events were observed in both the vaccine arms. No serious adverse event was reported.

Conclusion: The study results indicate that the TeddyVac^™ vaccine is immunogenic, safe and non-inferior to the comparator Vaccine when administered to healthy subjects of 10 to 60 years of age.

Ctri registration number: CTRI/2021/07/035112.

Keywords: Non-inferiority; TeddyVac™; diphtheria; immunogenicity; safety; tetanus.

Plain language summary

In a randomised, multicentre study, TeddyVac^™ vaccine of Human Biologicals Institute was found to be immunogenic, safe and non-inferior to an existing commercial brand when administered to healthy subjects of 10 to 60 years of age.