Scientific Publications by FDA Staff

J Infect Dis 2015 Jan 7 [Epub ahead of print]

Comparison of the immunogenicity of various inactivated polio vaccine booster doses by intradermal versus intramuscular routes in HIV-infected adults.

Troy SB, Kouiavskaia D, Siik J, Kochba E, Beydoun H, Mirochnitchenko O, Levin Y, Khardori N, Chumakov K, Maldonado Y

BACKGROUND: Inactivated polio vaccine (IPV) is necessary for global polio eradication because oral polio vaccine can rarely cause poliomyelitis as it mutates and may fail to provide adequate immunity in immunocompromised populations. However, IPV is unaffordable for many developing countries. Intradermal IPV shows promise as a means to decrease the effective dose and cost of IPV, but prior studies, all using 20% of the intramuscular dose, resulted in inferior antibody titers. Methods. We randomized 231 adults with well-controlled human immunodeficiency virus infection 2:2:2:1 to receive 40% dose intradermal IPV, 20% dose intradermal IPV, full dose intramuscular IPV, or 40% dose intramuscular IPV (ClinicalTrials.gov NCT01686503). Intradermal vaccination was done using the NanoPass MicronJet600 microneedles device. RESULTS: Baseline immunity was 87%, 90%, and 66% against polio serotypes 1, 2, and 3 respectively. After vaccination, antibody titers increased a median of 64-fold. Vaccine response to 40% intradermal IPV was comparable to full dose intramuscular IPV, and resulted in higher (though not significantly) antibody titers. Intradermal administration had higher local side effects (redness and itching), but similar systemic side effects, and was preferred by study participants over intramuscular administration. CONCLUSIONS: A 60% IPV dose reduction without reducing antibody titers is possible through intradermal administration.