The Duration of Intestinal Immunity After an Inactivated Poliovirus Vaccine Booster Dose in Children Immunized With Oral Vaccine: A Randomized Controlled Trial.
Jacob John, Sidhartha Giri, Arun S Karthikeyan, Dipti Lata, Shalini Jeyapaul, Anand K Rajan, Nirmal Kumar, Pavithra Dhanapal, Jayalakshmi Venkatesan, Mohanraj Mani, Janardhanan Hanusha, Uma Raman, Prabhakar D Moses, Asha Abraham, Sunil Bahl, Ananda S Bandyopadhyay, Mohammad Ahmad, Nicholas C Grassly, Gagandeep Kang
Author Information
Jacob John: Department of Community Health, Christian Medical College, Vellore, Tamil Nadu, India.
Sidhartha Giri: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Arun S Karthikeyan: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Dipti Lata: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Shalini Jeyapaul: Department of Community Health, Christian Medical College, Vellore, Tamil Nadu, India.
Anand K Rajan: Department of Clinical Virology, Christian Medical College, Vellore, Tamil Nadu, India.
Nirmal Kumar: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Pavithra Dhanapal: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Jayalakshmi Venkatesan: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Mohanraj Mani: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Janardhanan Hanusha: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Uma Raman: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Prabhakar D Moses: Department of Clinical Virology, Christian Medical College, Vellore, Tamil Nadu, India.
Asha Abraham: Department of Clinical Virology, Christian Medical College, Vellore, Tamil Nadu, India.
Sunil Bahl: WHO Regional Office for South-East Asia, New Delhi, India.
Ananda S Bandyopadhyay: Bill & Melinda Gates Foundation, Seattle, Washington, USA.
Mohammad Ahmad: WHO Country Office, New Delhi, India.
Nicholas C Grassly: Department of Infectious Disease Epidemiology, Imperial College London, UK.
Gagandeep Kang: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Background: In 2014, 2 studies showed that inactivated poliovirus vaccine (IPV) boosts intestinal immunity in children previously immunized with oral poliovirus vaccine (OPV). As a result, IPV was introduced in mass campaigns to help achieve polio eradication. Methods: We conducted an open-label, randomized, controlled trial to assess the duration of the boost in intestinal immunity following a dose of IPV given to OPV-immunized children. Nine hundred healthy children in Vellore, India, aged 1-4 years were randomized (1:1:1) to receive IPV at 5 months (arm A), at enrollment (arm B), or no vaccine (arm C). The primary outcome was poliovirus shedding in stool 7 days after bivalent OPV challenge at 11 months. Results: For children in arms A, B, and C, 284 (94.7%), 297 (99.0%), and 296 (98.7%), respectively, were eligible for primary per-protocol analysis. Poliovirus shedding 7 days after challenge was less prevalent in arms A and B compared with C (24.6%, 25.6%, and 36.4%, respectively; risk ratio 0.68 [95% confidence interval: 0.53-0.87] for A versus C, and 0.70 [0.55-0.90] for B versus C). Conclusions: Protection against poliovirus remained elevated 6 and 11 months after an IPV boost, although at a lower level than reported at 1 month. Clinical Trials Registration: CTRI/2014/09/004979.
