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Previous Volume 356:1536-1544 April 12, 2007 Number 15 Next

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ABSTRACT

Background After poliomyelitis has been eradicated, access to live polioviruses will be highly restricted and the use of oral poliovirus vaccine (OPV) will probably be discontinued. Countries using OPV must decide whether to switch to inactivated poliovirus vaccine (IPV) or stop polio vaccination. Because data on the immunogenicity of IPV in tropical developing countries are limited, we conducted a randomized, controlled trial of IPV in Cuba.

Methods The study population consisted of healthy infants born in Havana. A total of 166 infants were randomly assigned to two groups. Group A received a combination of the diphtheria–pertussis–tetanus (DPT) vaccine, the Haemophilus influenzae type b (Hib) vaccine, and IPV (DPT-Hib-IPV) at 6, 10, and 14 weeks of age. Group B, the control group, received a combination of the DPT vaccine and the Hib vaccine at 6, 10, and 14 weeks of age. Another group (group C, 100 infants), which did not undergo randomization at the same time as groups A and B, received the DPT-Hib-IPV combination at 8 and 16 weeks of age. Serum samples were collected before vaccination and at least 4 weeks after the last dose. Stool samples were obtained before and 7 days after challenge with OPV.

Results The seroconversion rates in group A were 94%, 83%, and 100% for types 1, 2, and 3 poliovirus, respectively. There were no seroconversions in group B. The seroconversion rates in group C were 90%, 89%, and 90% for poliovirus types 1, 2, and 3, respectively. For groups A, B, and C, the virus isolation rates after challenge with OPV were 94%, 91%, and 97%, respectively, and the mean log₁₀ viral titers of any serotype were 3.46, 3.89, and 3.37, respectively. There was one major adverse event, an episode of hypotonia.

Conclusions Vaccination with two or three doses of IPV resulted in a rate of seroconversion of at least 90%, except for seroconversion against type 2. The viral titer of OPV shed in the stool after OPV challenge was reduced in both groups receiving IPV. (ClinicalTrials.gov number, NCT00260312 [ClinicalTrials.gov] .)

Source Information

The institutions of the Cuba IPV Study Collaborative Group and their representatives (Miguel Galindo, M.D., Cuban Ministry of Public Health, Havana; Pedro Más Lago, M.D., Ph.D., Pedro Kourí Institute for Tropical Medicine, Havana; Victor Cáceres, M.D., M.P.H., Centers for Disease Control and Prevention, Atlanta; Mauricio Landaverde, M.D., Pan American Health Organization, Washington, DC; and Roland Sutter, M.D., M.P.H.&T.M., World Health Organization, Geneva) assume responsibility for the overall content and integrity of the article.

Address reprint requests to Dr. Cáceres at the Centers for Disease Control and Prevention, Coordinating Office for Global Health, Division of Epidemiology and Surveillance Capacity Development, Mailstop E-93, 1600 Clifton Rd., Atlanta, GA 30333.

Full Text of this Article

This article has been cited by other articles:

• Rodriguez, F V, Lopez, N B, Choonara, I (2008). Child health in Cuba. Arch. Dis. Child. 93: 991-993 [Full Text]  
• Ehrenfeld, E., Chumakov, K. (2008). Monovalent Oral Poliovirus Vaccines -- A Good Tool but Not a Total Solution. NEJM 359: 1726-1727 [Full Text]  
• (2007). Inactivated Poliovirus Vaccine Immunogenic in Cuban Infants. JWatch Infect. Diseases 2007: 1-1 [Full Text]