title: Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru.
abstract: In a randomized, placebo-controlled, monocenter, observer blinded study conducted in an area where dengue is endemic, we assessed the safety and immunogenicity of a recombinant, live, attenuated, tetravalent dengue vaccine candidate (CYD-TDV) in 2-11 year-olds with varying levels of pre-existing yellow-fever immunity due to vaccination 1-7 years previously. 199 children received 3 injections of CYD-TDV (months 0, 6 and 12) and 99 received placebo (months 0 and 6) or pneumococcal polysaccharide vaccine (month 12). One month after the third dengue vaccination, serotype specific neutralizing antibody GMTs were in the range of 178-190 (1/dil) (versus 16.7-38.1 in the control group), a 10-20 fold-increase from baseline, and 94% of vaccines were seropositive to all four serotypes (versus 39% in the control group). There were no vaccine-related SAEs. The observed reactogenicity profile was consistent with phase I studies, with severity grade 1-2 injection site pain, headache, malaise and fever most frequently reported and no increase after subsequent vaccinations. Virologically confirmed dengue cases were seen after completion of the 3 doses: 1 in the CYD-TDV group (N=199), and 3 in the control group (N=99). A 3-dose regimen of CYD-TDV had a good safety profile in 2-11 year olds with a history of YF vaccination and elicited robust antibody responses that were balanced against the four serotypes.
authors.affiliation: Instituto de Investigacion Nutricional, Av. La Molina 1885, La Molina Lima-12, Peru.
authors.forename: Claudio F
authors.initials: CF
authors.lastname: Lanata
authors.forename: Teresa
authors.initials: T
authors.lastname: Andrade
authors.forename: Ana I
authors.initials: AI
authors.lastname: Gil
authors.forename: Cynthia
authors.initials: C
authors.lastname: Terrones
authors.forename: Omar
authors.initials: O
authors.lastname: Valladolid
authors.forename: Betzana
authors.initials: B
authors.lastname: Zambrano
authors.forename: Melanie
authors.initials: M
authors.lastname: Saville
authors.forename: Denis
authors.initials: D
authors.lastname: Crevat
mesh_terms: D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D002648:Child; D002675:Child, Preschool; D003715:Dengue / Q000453:epidemiology* / Q000276:immunology / Q000517:prevention & control*; D053059:Dengue Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D003716:Dengue Virus / Q000472:pathogenicity; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D010568:Peru / Q000453:epidemiology; D014611:Vaccination; D022341:Yellow Fever Vaccine
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D053059:Dengue Vaccines; D022341:Yellow Fever Vaccine