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Luis Sarmiento-Pérez

Assistant researcher

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Priming after a fractional dose of inactivated poliovirus vaccine

Author

  • Sonia Resik
  • Alina Tejeda
  • Roland W Sutter
  • Manuel Diaz
  • Luis Sarmiento
  • Nilda Alemañi
  • Gloria Garcia
  • Magilé Fonseca
  • Lai Heng Hung
  • Anna-Lea Kahn
  • Anthony Burton
  • J Mauricio Landaverde
  • R Bruce Aylward

Summary, in English

BACKGROUND: To reduce the costs of maintaining a poliovirus immunization base in low-income areas, we assessed the extent of priming immune responses after the administration of inactivated poliovirus vaccine (IPV).

METHODS: We compared the immunogenicity and reactogenicity of a fractional dose of IPV (one fifth of a full dose) administered intradermally with a full dose administered intramuscularly in Cuban infants at the ages of 4 and 8 months. Blood was collected from infants at the ages of 4 months, 8 months, 8 months 7 days, and 8 months 30 days to assess single-dose seroconversion, single-dose priming of immune responses, and two-dose seroconversion. Specimens were tested with a neutralization assay.

RESULTS: A total of 320 infants underwent randomization, and 310 infants (96.9%) fulfilled the study requirements. In the group receiving the first fractional dose of IPV, seroconversion to poliovirus types 1, 2, and 3 occurred in 16.6%, 47.1%, and 14.7% of participants, respectively, as compared with 46.6%, 62.8%, and 32.0% in the group receiving the first full dose of IPV (P<0.008 for all comparisons). A priming immune response to poliovirus types 1, 2, and 3 occurred in 90.8%, 94.0%, and 89.6% of participants, respectively, in the group receiving the fractional dose as compared with 97.6%, 98.3%, and 98.1% in the group receiving the full dose (P=0.01 for the comparison with type 3). After the administration of the second dose of IPV in the group receiving fractional doses, cumulative two-dose seroconversion to poliovirus types 1, 2, and 3 occurred in 93.6%, 98.1%, and 93.0% of participants, respectively, as compared with 100.0%, 100.0%, and 99.4% in the group receiving the full dose (P<0.006 for the comparisons of types 1 and 3). The group receiving intradermal injections had the greatest number of adverse events, most of which were minor in intensity and none of which had serious consequences.

CONCLUSIONS: This evaluation shows that vaccinating infants with a single fractional dose of IPV can induce priming and seroconversion in more than 90% of immunized infants. (Funded by the World Health Organization and the Pan American Health Organization; Australian New Zealand Clinical Trials Registry number, ACTRN12610001046099.).

Publishing year

2013-01-31

Language

English

Pages

24-416

Publication/Series

New England Journal of Medicine

Volume

368

Issue

5

Document type

Journal article

Publisher

Massachusetts Medical Society

Topic

  • Clinical Medicine

Keywords

  • Antibodies, Viral/blood
  • Cuba
  • Female
  • Humans
  • Immunization, Secondary
  • Infant
  • Injections, Intradermal
  • Injections, Intramuscular
  • Male
  • Poliomyelitis/immunology
  • Poliovirus/immunology
  • Poliovirus Vaccine, Inactivated/administration & dosage
  • Seroepidemiologic Studies

Status

Published

ISBN/ISSN/Other

  • ISSN: 0028-4793