Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults.

Autor: Troy SB; Department of Internal Medicine., Kouiavskaia D; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland., Siik J; Department of Internal Medicine., Kochba E; NanoPass Technologies, Nes Ziona, Israel., Beydoun H; Graduate Program in Public Health, Eastern Virginia Medical School, Norfolk., Mirochnitchenko O; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland., Levin Y; NanoPass Technologies, Nes Ziona, Israel., Khardori N; Department of Internal Medicine., Chumakov K; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland., Maldonado Y; Department of Pediatrics, Stanford University School of Medicine, California.
Jazyk: angličtina
Zdroj: The Journal of infectious diseases [J Infect Dis] 2015 Jun 15; Vol. 211 (12), pp. 1969-76. Date of Electronic Publication: 2015 Jan 07.
DOI: 10.1093/infdis/jiu841
Abstrakt: 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 standard dose used in intramuscular IPV, resulted in inferior antibody titers.
Methods: We randomly assigned 231 adults with well-controlled human immunodeficiency virus infection at a ratio of 2:2:2:1 to receive 40% of the standard dose of IPV intradermally, 20% of the standard dose intradermally, the full standard dose intramuscularly, or 40% of the standard dose intramuscularly. Intradermal vaccination was done using the NanoPass MicronJet600 microneedle device.
Results: Baseline immunity was 87%, 90%, and 66% against poliovirus serotypes 1, 2, and 3, respectively. After vaccination, antibody titers increased a median of 64-fold. Vaccine response to 40% of the standard dose administered intradermally was comparable to that of the standard dose of IPV administered intramuscularly and resulted in higher (although not significantly) antibody titers. Intradermal administration had higher a incidence of local side effects (redness and itching) but a similar incidence of systemic side effects and was preferred by study participants over intramuscular administration.
Conclusions: A 60% reduction in the standard IPV dose without reduction in antibody titers is possible through intradermal administration.
(© The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)
Databáze: MEDLINE