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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Monovalent type 1 oral poliovirus vaccine in newborns
New England Journal of Medicine, Volume 359, No. 16, Year 2008
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Description
BACKGROUND: In 1988, the World Health Assembly resolved to eradicate poliomyelitis. Although substantial progress toward this goal has been made, eradication remains elusive. In 2004, the World Health Organization called for the development of a potentially more immunogenic monovalent type 1 oral poliovirus vaccine. METHODS: We conducted a trial in Egypt to compare the immunogenicity of a newly licensed monovalent type 1 oral poliovirus vaccine with that of a trivalent oral poliovirus vaccine. Subjects were randomly assigned to receive one dose of monovalent type 1 oral poliovirus vaccine or trivalent oral poliovirus vaccine at birth. Thirty days after birth, a single challenge dose of monovalent type 1 oral poliovirus vaccine was administered in all subjects. Shedding of serotype 1 poliovirus was assessed through day 60. RESULTS: A total of 530 subjects were enrolled, and 421 fulfilled the study requirements. Thirty days after the study vaccines were administered, the rate of seroconversion to type 1 poliovirus was 55.4% in the monovalent-vaccine group, as compared with 32.1% in the trivalent-vaccine group (P<0.001). Among those with a high reciprocal titer of maternally derived antibodies against type 1 poliovirus (>64), 46.0% of the subjects in the monovalent-vaccine group underwent seroconversion, as compared with 21.3% in the trivalent-vaccine group (P<0.001). Seven days after administration of the challenge dose of monovalent type 1 vaccine, a significantly lower proportion of subjects in the monovalent-vaccine group than in the trivalent-vaccine group excreted type 1 poliovirus (25.9% vs. 41.5%, P = 0.001). None of the serious adverse events reported were attributed to the trial interventions. CONCLUSIONS: When given at birth, monovalent type 1 oral poliovirus vaccine is superior to trivalent oral poliovirus vaccine in inducing humoral antibodies against type 1 poliovirus, overcoming high preexisting levels of maternally derived antibodies, and increasing the resistance to excretion of type 1 poliovirus after administration of a challenge dose. (Current Controlled Trials number, ISRCTN76316509.) Copyright © 2008 Massachusetts Medical Society. All rights reserved.
Authors & Co-Authors
El-Sayed, Nasr M.
Egypt, Cairo
Egyptian Ministry of Health and Population
El Gamal, Y.
Egypt, Cairo
Ain Shams University
Abbassy, Ahmed Amr
Egypt, Alexandria
Alexandria University
Seoud, Iman
Egypt, Cairo
Cairo University Hospitals
Salama, Maha
Switzerland, Geneva
Organisation Mondiale de la Santé
Kandeel, Amr M.
Egypt, Cairo
Egyptian Ministry of Health and Population
Hossny, Elham
Egypt, Cairo
Ain Shams University
Shawky, Ahmed
Egypt, Alexandria
Alexandria University
Hussein, Heba Abou M.
Egypt, Cairo
Cairo University Hospitals
Pallansch, Mark A.
United States, Atlanta
Centers for Disease Control and Prevention
van der Avoort, Harrie G.A.M.
Netherlands, Bilthoven
Rijksinstituut Voor Volksgezondheid en Milieu
Burton, Anthony H.
Switzerland, Geneva
Organisation Mondiale de la Santé
Sreevatsava, Meghana
Switzerland, Geneva
Organisation Mondiale de la Santé
Malankar, Pradeep
Switzerland, Geneva
Organisation Mondiale de la Santé
Wahdan, Mohammed Helmy
Switzerland, Geneva
Organisation Mondiale de la Santé
Sutter, Roland Walter
Switzerland, Geneva
Organisation Mondiale de la Santé
Statistics
Citations: 69
Authors: 16
Affiliations: 7
Identifiers
Doi:
10.1056/NEJMoa0800390
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Health System And Policy
Study Locations
Egypt