A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

Hitt Sharma; Sameer Parekh; Pramod Pujari; Sunil Shewale; Shivani Desai; Anand Kawade; Sanjay Lalwani; M. D. Ravi; Veena Kamath; Jagannath Mahopatra; Ganesh Kulkarni; Deepak Tayade; Padmasani Venkat Ramanan; Kheya Ghosh Uttam; Lalit Rawal; Avinash Gawande; N. Ravi Kumar; Nishikant Tiple; Jayant Vagha; Pareshkumar Thakkar; Prashant Khandgave; Bhaskar Jedhe Deshmukh; Anurag Agarwal; Vikas Dogar; Manish Gautam; K. S. Jaganathan; Rakesh Kumar; Inderjit Sharma; Sunil Gairola

doi:10.1038/s41541-024-00828-w

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL^®) in infants

Hitt Sharma^*
, Sameer Parekh
, Pramod Pujari
, Sunil Shewale
, Shivani Desai
, Anand Kawade
, Sanjay Lalwani
, M. D. Ravi
, Veena Kamath
, Jagannath Mahopatra
, Ganesh Kulkarni
, Deepak Tayade
, Padmasani Venkat Ramanan
, Kheya Ghosh Uttam
, Lalit Rawal
, Avinash Gawande
, N. Ravi Kumar
, Nishikant Tiple
, Jayant Vagha
, Pareshkumar Thakkar

Prashant Khandgave, Bhaskar Jedhe Deshmukh, Anurag Agarwal, Vikas Dogar, Manish Gautam, K. S. Jaganathan, Rakesh Kumar, Inderjit Sharma, Sunil Gairola

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL^®) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed. Clinical Trial Registration – CTRI/2019/11/022052.

Original language	English
Article number	41
Journal	npj Vaccines
Volume	9
Issue number	1
DOIs	https://doi.org/10.1038/s41541-024-00828-w
Publication status	Published - 12-2024

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

All Science Journal Classification (ASJC) codes

Immunology
Pharmacology
Infectious Diseases
Pharmacology (medical)

Access to Document

10.1038/s41541-024-00828-w

Cite this

Sharma, H., Parekh, S., Pujari, P., Shewale, S., Desai, S., Kawade, A., Lalwani, S., Ravi, M. D., Kamath, V., Mahopatra, J., Kulkarni, G., Tayade, D., Ramanan, P. V., Uttam, K. G., Rawal, L., Gawande, A., Kumar, N. R., Tiple, N., Vagha, J., ... Gairola, S. (2024). A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL^®) in infants. npj Vaccines, 9(1), Article 41. https://doi.org/10.1038/s41541-024-00828-w

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title = "A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL{\textregistered}) in infants",

abstract = "A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL{\textregistered}) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95\% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95\% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed. Clinical Trial Registration – CTRI/2019/11/022052.",

author = "Hitt Sharma and Sameer Parekh and Pramod Pujari and Sunil Shewale and Shivani Desai and Anand Kawade and Sanjay Lalwani and Ravi, \{M. D.\} and Veena Kamath and Jagannath Mahopatra and Ganesh Kulkarni and Deepak Tayade and Ramanan, \{Padmasani Venkat\} and Uttam, \{Kheya Ghosh\} and Lalit Rawal and Avinash Gawande and Kumar, \{N. Ravi\} and Nishikant Tiple and Jayant Vagha and Pareshkumar Thakkar and Prashant Khandgave and Deshmukh, \{Bhaskar Jedhe\} and Anurag Agarwal and Vikas Dogar and Manish Gautam and Jaganathan, \{K. S.\} and Rakesh Kumar and Inderjit Sharma and Sunil Gairola",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = dec,

doi = "10.1038/s41541-024-00828-w",

language = "English",

volume = "9",

journal = "npj Vaccines",

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Sharma, H, Parekh, S, Pujari, P, Shewale, S, Desai, S, Kawade, A, Lalwani, S, Ravi, MD, Kamath, V, Mahopatra, J, Kulkarni, G, Tayade, D, Ramanan, PV, Uttam, KG, Rawal, L, Gawande, A, Kumar, NR, Tiple, N, Vagha, J, Thakkar, P, Khandgave, P, Deshmukh, BJ, Agarwal, A, Dogar, V, Gautam, M, Jaganathan, KS, Kumar, R, Sharma, I & Gairola, S 2024, 'A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL^®) in infants', npj Vaccines, vol. 9, no. 1, 41. https://doi.org/10.1038/s41541-024-00828-w

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T1 - A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

AU - Sharma, Hitt

AU - Parekh, Sameer

AU - Pujari, Pramod

AU - Shewale, Sunil

AU - Desai, Shivani

AU - Kawade, Anand

AU - Lalwani, Sanjay

AU - Ravi, M. D.

AU - Kamath, Veena

AU - Mahopatra, Jagannath

AU - Kulkarni, Ganesh

AU - Tayade, Deepak

AU - Ramanan, Padmasani Venkat

AU - Uttam, Kheya Ghosh

AU - Rawal, Lalit

AU - Gawande, Avinash

AU - Kumar, N. Ravi

AU - Tiple, Nishikant

AU - Vagha, Jayant

AU - Thakkar, Pareshkumar

AU - Khandgave, Prashant

AU - Deshmukh, Bhaskar Jedhe

AU - Agarwal, Anurag

AU - Dogar, Vikas

AU - Gautam, Manish

AU - Jaganathan, K. S.

AU - Kumar, Rakesh

AU - Sharma, Inderjit

AU - Gairola, Sunil

PY - 2024/12

Y1 - 2024/12

N2 - A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL®) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed. Clinical Trial Registration – CTRI/2019/11/022052.

AB - A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL®) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed. Clinical Trial Registration – CTRI/2019/11/022052.

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