Priming after a fractional dose of inactivated poliovirus vaccine
(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.).
(Less)
- author
- publishing date
- 2013-01-31
- type
- Contribution to journal
- publication status
- published
- subject
- 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
- 2024-04-16 16:47:13
@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<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.</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}},
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}},
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}},
}