Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunisation and outbreak response: an open-label, randomised controlled trial

• Published in: The Lancet (British edition) 2019-06, Vol.393 (10191), p.2624-2634
• Main Authors: Snider, Cynthia J, Zaman, Khalequ, Estivariz, Concepcion F, Yunus, Mohammad, Weldon, William C, Wannemuehler, Kathleen A, Oberste, M Steven, Pallansch, Mark A, Wassilak, Steven GF, Bari, Tajul Islam A, Anand, Abhijeet
• Format: Article
• Language: English
• Subjects: Adapters; Age; Antibodies; Antibodies, Viral - metabolism; Bangladesh; Disease control; Disease Outbreaks - prevention & control; Evidence-based medicine; Female; Humans; Immunization; Immunization, Secondary; Immunogenicity; Infant; Infants; Injections, Intramuscular - instrumentation; Male; Outbreaks; Poliomyelitis - immunology; Poliomyelitis - prevention & control; Poliovirus - immunology; Poliovirus Vaccine, Inactivated - administration & dosage; Poliovirus Vaccine, Inactivated - immunology; Randomization; Seroconversion; Serotypes; Thigh; Vaccines
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(19)30503-3

Intradermal administration of fractional inactivated poliovirus vaccine (fIPV) is a dose-sparing alternative to the intramuscular full dose. We aimed to compare the immunogenicity of two fIPV doses versus one IPV dose for routine immunisation, and also assessed the immunogenicity of an fIPV booster dose for an outbreak response. We did an open-label, randomised, controlled, inequality, non-inferiority trial in two clinics in Dhaka, Bangladesh. Healthy infants were randomly assigned at 6 weeks to one of four groups: group A received IPV at age 14 weeks and IPV booster at age 22 weeks; group B received IPV at age 14 weeks and fIPV booster at age 22 weeks; group C received IPV at age 6 weeks and fIPV booster at age 22 weeks; and group D received fIPV at 6 weeks and 14 weeks and fIPV booster at age 22 weeks. IPV was administered by needle-syringe as an intramuscular full dose (0·5 mL), and fIPV was administered intradermally (0·1 mL of the IPV formulation was administered using the 0·1 mL HelmJect auto-disable syringe with a Helms intradermal adapter). Both IPV and fIPV were administered on the outer, upper right thigh of infants. The primary outcome was vaccine response to poliovirus types 1, 2, and 3 at age 22 weeks (routine immunisation) and age 26 weeks (outbreak response). Vaccine response was defined as seroconversion from seronegative (