Immunogenicity of Fractional Dose Inactivated Poliovirus Vaccine in India.


Journal

Journal of the Pediatric Infectious Diseases Society
ISSN: 2048-7207
Titre abrégé: J Pediatric Infect Dis Soc
Pays: England
ID NLM: 101586049

Informations de publication

Date de publication:
23 Feb 2022
Historique:
received: 11 03 2021
accepted: 17 09 2021
pubmed: 19 11 2021
medline: 26 2 2022
entrez: 18 11 2021
Statut: ppublish

Résumé

Following the withdrawal of Sabin type 2 from trivalent oral poliovirus vaccine (tOPV) in 2016, the introduction of ≥1 dose of inactivated poliovirus vaccine (IPV) in routine immunization was recommended, either as 1 full dose (0.5mL, intramuscular) or 2 fractional doses of IPV (fIPV-0.1mL, intradermal). India opted for fIPV. We conducted a comparative assessment of IPV and fIPV. This was a 4-arm, open-label, multicenter, randomized controlled trial. Infants were enrolled and vaccines administered according to the study design, and the blood was drawn at age 6, 14, and 18 weeks for neutralization testing against all 3 poliovirus types. Study enrolled 799 infants. The seroconversion against type 2 poliovirus with 2 fIPV doses was 85.8% (95% confidence interval [CI]: 80.1%-90.0%) when administered at age 6 and 14 weeks, 77.0% (95% CI: 70.5-82.5) when given at age 10 and 14 weeks, compared to 67.9% (95% CI: 60.4-74.6) following 1 full-dose IPV at age 14 weeks. The study demonstrated the superiority of 2 fIPV doses over 1 full-dose IPV in India. Doses of fIPV given at 6 and 14 weeks were more immunogenic than those given at 10 and 14 weeks. Clinical Trial Registry of India (CTRI). Clinical trial registration number was CTRI/2017/02/007793.

Identifiants

pubmed: 34791350
pii: 6430128
doi: 10.1093/jpids/piab091
pmc: PMC8865014
doi:

Substances chimiques

Antibodies, Viral 0
Poliovirus Vaccine, Inactivated 0
Poliovirus Vaccine, Oral 0

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

60-68

Subventions

Organisme : World Health Organization
ID : 001
Pays : International
Organisme : WHO, Geneva
ID : 65163
Organisme : World Health Organization
ID : 65163
Pays : International

Informations de copyright

© The Author(s) 2021. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society.

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Auteurs

Mohammad Ahmad (M)

Office of the WHO Representative to India, New Delhi, India.

Harish Verma (H)

World Health Organization, Geneva, Switzerland.

Jagadish Deshpande (J)

ICMR-National Institute of Virology, Pune, Maharashtra, India.

Abhishek Kunwar (A)

Office of the WHO Representative to India, New Delhi, India.

Ashish Bavdekar (A)

King Edward Memorial Hospital, Pune, Maharashtra, India.

Niranjana S Mahantashetti (NS)

K.L.E Academy of Higher Education and Research, Belagavi, Karnataka, India.

Balasundaram Krishnamurthy (B)

Mysore Medical College, Mysore, Karnataka, India.

Manish Jain (M)

Mahatma Gandhi Institute of Medical Sciences, Sewagram, Wardha, Maharashtra, India.

Mannancheril A Mathew (MA)

Malankara Orthodox Syrian Church Medical College, Kolenchery, Kerala, India.

Shailesh D Pawar (SD)

ICMR-National Institute of Virology, Pune, Maharashtra, India.

Deepa K Sharma (DK)

ICMR-National Institute of Virology, Pune, Maharashtra, India.

Raman Sethi (R)

Office of the WHO Representative to India, New Delhi, India.

Jayaseelan Visalakshi (J)

World Health Organization, Geneva, Switzerland.

Lalitendu Mohanty (L)

Clinical Operations, Panacea Biotec Ltd, New Delhi, India.

Sunil Bahl (S)

South East Asian Regional Office of World Health Organization, New Delhi, India.

Pradeep Haldar (P)

Ministry of Health and Family Welfare, Government of India, New Delhi, India.

Roland W Sutter (RW)

World Health Organization, Geneva, Switzerland.

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Classifications MeSH