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Randomized Controlled Trial
. 2022 Feb 23;11(2):60-68.
doi: 10.1093/jpids/piab091.

Immunogenicity of Fractional Dose Inactivated Poliovirus Vaccine in India

Mohammad Ahmad  1 , Harish Verma  2 , Jagadish Deshpande  3 , Abhishek Kunwar  1 , Ashish Bavdekar  4 , Niranjana S Mahantashetti  5 , Balasundaram Krishnamurthy  6 , Manish Jain  7 , Mannancheril A Mathew  8 , Shailesh D Pawar  3 , Deepa K Sharma  3 , Raman Sethi  1 , Jayaseelan Visalakshi  2 , Lalitendu Mohanty  9 , Sunil Bahl  10 , Pradeep Haldar  11 , Roland W Sutter  2
Affiliations
Randomized Controlled Trial

Immunogenicity of Fractional Dose Inactivated Poliovirus Vaccine in India

Mohammad Ahmad et al. J Pediatric Infect Dis Soc. .

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: EPI schedule; India; fractional dose inactivated poliovirus vaccine; immunogenicity.

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Figures

Figure 1.
Figure 1.
Consort flowchart.
Figure 2.
Figure 2.
Type 2 cumulative seroconversion difference between the different comparison arms with 95% CI for the difference.
Figure 3.
Figure 3.
(a) Reverse cumulative distributions for poliovirus type 1 titers in log 2 scale. (b) Reverse cumulative distributions for poliovirus type 2 titers in log 2 scale. (c) Reverse cumulative distributions for poliovirus type 3 titers in log 2 scale.
See this image and copyright information in PMC

References

    1. Forty-First World Health Assembly. WHA41.28 – global eradication of poliomyelitis by the year 2000 [Internet]. Geneva; 1988. Accessed February 4, 2020. polioresolution4128.pdf
    1. World Health Organization. WHO South-East Asia Region certified polio-free [Internet]. SEARO. Accessed September 11, 2019. http://www.searo.who.int/mediacentre/releases/2014/pr1569/en/
    1. WHO. Poliomyelitis [Internet]. Accessed December 20, 2019. https://www.who.int/news-room/fact-sheets/detail/poliomyelitis
    1. GPEI-Endemic Countries [Internet]. Accessed September 16, 2019. http://polioeradication.org/where-we-work/polio-endemic-countries/
    1. Adamu US, Archer WR, Braka F, et al. . Progress toward poliomyelitis eradication – Nigeria, January 2018-May 2019. MMWR Morb Mortal Wkly Rep 2019; 68:642–6. - PMC - PubMed

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