Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines

Abstract

Objective: Comparison of a fractional inactivated poliovirus vaccine (IPV) dose administered intradermally (ID) to a full dose administered intramuscularly (IM).

Methods: Healthy Filipino infants were randomized to receive IPV as either a fractional (1/5(th)) dose ID by needle injection or a full dose IM at 6, 10, and 14 weeks and a booster at 15-18 months of age. Pre- and post-vaccination anti-polio 1, 2, and 3 titers were estimated. Adverse events were monitored throughout the study.

Results: Following primary series vaccination, anti-polio 1, 2, and 3 titers were ≥8 (1/dil) in 99-100% of participants, and the ID route was non-inferior to the IM route. Depending on the study group, antibody persistence was detected in 83-100% of participants, and the booster dose resulted in a strong anamnestic response in all groups. The incidence of adverse events in each group was similar, except for injection-site erythema (higher in the ID group).

Conclusions: Primary series and booster vaccination of a fractional IPV dose administered by the ID route was highly immunogenic and well tolerated. These data confirm the medical validity of using fractional ID doses of IPV. The programmatic feasibility of implementing affordable mass vaccination programs based on this delivery mode has yet to be established.

Trial registration: ClinicalTrials.gov NCT00604058 NCT00885157.