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Monovalent type 1 oral poliovirus vaccine in newborns.
N Engl J Med. 2008 Oct 16; 359(16):1655-65.NEJM

Abstract

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.)

Authors+Show Affiliations

Ministry of Health and Population, Cairo, Egypt.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18923170

Citation

el-Sayed, Nasr, et al. "Monovalent Type 1 Oral Poliovirus Vaccine in Newborns." The New England Journal of Medicine, vol. 359, no. 16, 2008, pp. 1655-65.
el-Sayed N, el-Gamal Y, Abbassy AA, et al. Monovalent type 1 oral poliovirus vaccine in newborns. N Engl J Med. 2008;359(16):1655-65.
el-Sayed, N., el-Gamal, Y., Abbassy, A. A., Seoud, I., Salama, M., Kandeel, A., Hossny, E., Shawky, A., Hussein, H. A., Pallansch, M. A., van der Avoort, H. G., Burton, A. H., Sreevatsava, M., Malankar, P., Wahdan, M. H., & Sutter, R. W. (2008). Monovalent type 1 oral poliovirus vaccine in newborns. The New England Journal of Medicine, 359(16), 1655-65. https://doi.org/10.1056/NEJMoa0800390
el-Sayed N, et al. Monovalent Type 1 Oral Poliovirus Vaccine in Newborns. N Engl J Med. 2008 Oct 16;359(16):1655-65. PubMed PMID: 18923170.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Monovalent type 1 oral poliovirus vaccine in newborns. AU - el-Sayed,Nasr, AU - el-Gamal,Yehia, AU - Abbassy,Ahmed-Amr, AU - Seoud,Iman, AU - Salama,Maha, AU - Kandeel,Amr, AU - Hossny,Elham, AU - Shawky,Ahmed, AU - Hussein,Heba Abou, AU - Pallansch,Mark A, AU - van der Avoort,Harrie G A M, AU - Burton,Anthony H, AU - Sreevatsava,Meghana, AU - Malankar,Pradeep, AU - Wahdan,Mohamed H, AU - Sutter,Roland W, PY - 2008/10/17/pubmed PY - 2008/10/24/medline PY - 2008/10/17/entrez SP - 1655 EP - 65 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 359 IS - 16 N2 - 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.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/18923170/full_citation L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa0800390?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -