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Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial].
Adigweme, Ikechukwu; Akpalu, Edem; Yisa, Mohammed; Donkor, Simon; Jarju, Lamin B; Danso, Baba; Mendy, Anthony; Jeffries, David; Njie, Abdoulie; Bruce, Andrew; Royals, Michael; Goodson, James L; Prausnitz, Mark R; McAllister, Devin; Rota, Paul A; Henry, Sebastien; Clarke, Ed.
Afiliação
  • Adigweme I; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Akpalu E; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Yisa M; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Donkor S; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Jarju LB; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Danso B; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Mendy A; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Jeffries D; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Njie A; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Bruce A; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia.
  • Royals M; Micron Biomedical, Inc, 311 Ferst Dr, NW, Suite L1309, Atlanta, GA, 30332, USA.
  • Goodson JL; Accelerated Disease Control Branch, Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Prausnitz MR; Micron Biomedical, Inc, 311 Ferst Dr, NW, Suite L1309, Atlanta, GA, 30332, USA.
  • McAllister D; Micron Biomedical, Inc, 311 Ferst Dr, NW, Suite L1309, Atlanta, GA, 30332, USA.
  • Rota PA; Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Henry S; Micron Biomedical, Inc, 311 Ferst Dr, NW, Suite L1309, Atlanta, GA, 30332, USA.
  • Clarke E; Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia. Ed.Clarke@lshtm.ac.uk.
Trials ; 23(1): 775, 2022 Sep 14.
Article em En | MEDLINE | ID: mdl-36104719
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Rubéola (Sarampo Alemão) / Vacina contra Sarampo / Vacina contra Rubéola / Sarampo Tipo de estudo: Clinical_trials / Prognostic_studies / Qualitative_research Limite: Adolescent / Adult / Humans / Infant País como assunto: Africa Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Rubéola (Sarampo Alemão) / Vacina contra Sarampo / Vacina contra Rubéola / Sarampo Tipo de estudo: Clinical_trials / Prognostic_studies / Qualitative_research Limite: Adolescent / Adult / Humans / Infant País como assunto: Africa Idioma: En Ano de publicação: 2022 Tipo de documento: Article