title: Safety and Immunogenicity of a Dengue Virus Serotype-1 Purified-Inactivated Vaccine: Results of a Phase 1 Clinical Trial.
abstract: We describe the results from a human clinical trial of a dengue virus serotype-1, purified-inactivated vaccine (DENV-1 PIV) adjuvanted with aluminum hydroxide. This first-in-man, Phase 1, open-label clinical trial consisted of two groups of flavivirus-naïve healthy adult volunteers that received two intramuscular vaccine doses of either 2.5 μg or 5 μg of DENV-1 PIV administered on days 0 and 28. Following vaccination, both vaccine doses exhibited an acceptable safety profile with minimal injection site and systemic reactions. By study day 42, 2 weeks following the second vaccine dose, all volunteers in both vaccine groups developed serum-neutralizing antibodies against DENV-1. Additional testing using an enzyme-linked immunosorbent assay demonstrated induction of a humoral immune response following both vaccine doses. The DENV-1 PIV was safe and immunogenic in a small number of volunteers supporting development and further testing of a tetravalent DENV PIV formulation.
authors.forename: Luis Javier
authors.initials: LJ
authors.lastname: Martinez
authors.forename: Leyi
authors.initials: L
authors.lastname: Lin
authors.forename: Jason M
authors.initials: JM
authors.lastname: Blaylock
authors.forename: Arthur G
authors.initials: AG
authors.lastname: Lyons
authors.forename: Kristen M
authors.initials: KM
authors.lastname: Bauer
authors.forename: Rafael
authors.initials: R
authors.lastname: De La Barrera
authors.forename: Monika
authors.initials: M
authors.lastname: Simmons
authors.forename: Richard G
authors.initials: RG
authors.lastname: Jarman
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Currier
authors.forename: Heather
authors.initials: H
authors.lastname: Friberg
authors.forename: Janine R
authors.initials: JR
authors.lastname: Danko
authors.forename: Nimfa C
authors.initials: NC
authors.lastname: Teneza-Mora
authors.forename: J Robert
authors.initials: JR
authors.lastname: Putnak
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Eckels
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Thomas
mesh_terms: D000293:Adolescent; D000328:Adult; D057134:Antibodies, Neutralizing / Q000276:immunology; D000914:Antibodies, Viral / Q000276:immunology; D053059:Dengue Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D003716:Dengue Virus / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology; D007075:Immunoglobulin M / Q000276:immunology; D008297:Male; D008875:Middle Aged; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D053059:Dengue Vaccines; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D015164:Vaccines, Inactivated