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Priming after a fractional dose of inactivated poliovirus vaccine

Resik, Sonia ; Tejeda, Alina ; Sutter, Roland W ; Diaz, Manuel ; Sarmiento, Luis ; Alemañi, Nilda ; Garcia, Gloria ; Fonseca, Magilé ; Hung, Lai Heng and Kahn, Anna-Lea LU , et al. (2013) In New England Journal of Medicine 368(5). p.24-416
Abstract

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... (More)

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.).

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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
in
New England Journal of Medicine
volume
368
issue
5
pages
9 pages
publisher
Massachusetts Medical Society
external identifiers
  • scopus:84873048082
  • pmid:23363495
ISSN
0028-4793
DOI
10.1056/NEJMoa1202541
language
English
LU publication?
no
id
432a4a76-9de2-4550-b159-43935edf318f
date added to LUP
2019-07-08 14:28:38
date last changed
2020-01-16 04:02:09
@article{432a4a76-9de2-4550-b159-43935edf318f,
  abstract     = {<p>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).</p><p>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.</p><p>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&lt;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&lt;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.</p><p>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.).</p>},
  author       = {Resik, Sonia and Tejeda, Alina and Sutter, Roland W and Diaz, Manuel and Sarmiento, Luis and Alemañi, Nilda and Garcia, Gloria and Fonseca, Magilé and Hung, Lai Heng and Kahn, Anna-Lea and Burton, Anthony and Landaverde, J Mauricio and Aylward, R Bruce},
  issn         = {0028-4793},
  language     = {eng},
  month        = {01},
  number       = {5},
  pages        = {24--416},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Priming after a fractional dose of inactivated poliovirus vaccine},
  url          = {http://dx.doi.org/10.1056/NEJMoa1202541},
  doi          = {10.1056/NEJMoa1202541},
  volume       = {368},
  year         = {2013},
}