Randomized Controlled Clinical Trial of Fractional Doses of Inactivated Poliovirus Vaccine Administered Intradermally by Needle-Free Device in Cuba

被引:108
作者
Resik, Sonia [1 ]
Tejeda, Alina [2 ]
Mas Lago, Pedro [1 ]
Diaz, Manuel [1 ]
Carmenates, Ania [2 ]
Sarmiento, Luis [1 ]
Alemani, Nilda [2 ]
Galindo, Belkis [1 ]
Burton, Anthony [3 ]
Friede, Martin [4 ]
Landaverde, Mauricio
Sutter, Roland W. [3 ]
机构
[1] Pedro Kouri Inst, Havana, Cuba
[2] Prov Hlth Off, Camaguey, Cuba
[3] WHO, CH-1211 Geneva, Switzerland
[4] Pan Amer Hlth Org, Washington, DC USA
关键词
ANTIBODY-RESPONSE; IMMUNE-RESPONSE; INFANTS; IMMUNOGENICITY; SAFETY; LIVE;
D O I
10.1086/651611
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background. As part of an evaluation of strategies to make inactivated poliovirus vaccine (IPV) affordable for developing countries, we conducted a clinical trial of fractional doses of IPV in Cuba. Methods. We compared the immunogenicity and reactogenicity of fractional-dose IPV (0.1 mL, or 1/5 of a full dose) given intradermally using a needle-free jet injector device compared with full doses given intramuscularly. Subjects were randomized at birth to receive IPV at 6, 10, and 14 weeks. Results. A total of 471 subjects were randomized to the 2 study groups, and 364 subjects fulfilled the study requirements. No significant differences at baseline were detected. Thirty days after completing the 3-dose schedule of IPV, 52.9%, 85.0%, and 69.0% of subjects in the fractional- dose IPV arm seroconverted for poliovirus types 1, 2, and 3, respectively, whereas 89.3%, 95.5%, and 98.9% of subjects in the full-dose IPV arm seroconverted for poliovirus types 1, 2, and 3, respectively (all comparisons, P < .001). The median titers of each poliovirus serotype were significantly lower in the intradermal arm than in the intramuscular arm (P < .001). Only minor local adverse effects and no moderate or serious adverse events were reported. Conclusions. This large-scale evaluation demonstrates the feasibility of fractional doses of IPV given intradermally as an antigen-sparing strategy but also shows that IPV given to infants at 6, 10, and 14 weeks of age results in suboptimal immunogenicity (especially for the fractional- dose arm).
引用
收藏
页码:1344 / 1352
页数:9
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