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.) 2008 Massachusetts Medical Society
RCT Entities:
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.) 2008 Massachusetts Medical Society
Authors: Kimberly M Thompson; Mark A Pallansch; Radboud J Duintjer Tebbens; Steve G Wassilak; Jong-Hoon Kim; Stephen L Cochi Journal: Risk Anal Date: 2013-03-05 Impact factor: 4.000
Authors: Michael Famulare; Stewart Chang; Jane Iber; Kun Zhao; Johnson A Adeniji; David Bukbuk; Marycelin Baba; Matthew Behrend; Cara C Burns; M Steven Oberste Journal: J Virol Date: 2015-10-14 Impact factor: 5.103
Authors: Sabine van der Sanden; Mark A Pallansch; Jan van de Kassteele; Nasr El-Sayed; Roland W Sutter; Marion Koopmans; Harrie van der Avoort Journal: J Virol Date: 2009-06-10 Impact factor: 5.103
Authors: Steven G F Wassilak; M Steven Oberste; Rudolph H Tangermann; Ousmane M Diop; Hamid S Jafari; Gregory L Armstrong Journal: J Infect Dis Date: 2014-11-01 Impact factor: 5.226
Authors: Kathleen M O'Reilly; Elias Durry; Obaid ul Islam; Arshad Quddus; Ni'ma Abid; Tahir P Mir; Rudi H Tangermann; R Bruce Aylward; Nicholas C Grassly Journal: Lancet Date: 2012-07-04 Impact factor: 79.321
Authors: Fatima Mir; Farheen Quadri; Ondrej Mach; Imran Ahmed; Zaid Bhatti; Asia Khan; Najeeb Ur Rehman; Elias Durry; Maha Salama; Steven M Oberste; William C Weldon; Roland W Sutter; Anita K M Zaidi Journal: Lancet Infect Dis Date: 2015-06-17 Impact factor: 25.071