Biomaterial Database

Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial. 2020

Anna P Durbin, and Kristen K Pierce, and Beth D Kirkpatrick, and Palmtama Grier, and Beulah P Sabundayo, and Helen He, and Michele Sausser, and Amy Falk Russell, and Jason Martin, and Donna Hyatt, and Melissa Cook, and Jeffrey R Sachs, and Andrew Wen-Tseng Lee, and Liman Wang, and Beth-Ann Coller, and Stephen S Whitehead

1Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

New dengue vaccines are needed to prevent this globally expanding vector-borne disease. The V180 vaccine candidate consists of four recombinant, soluble, dengue virus envelope glycoproteins and has been previously evaluated in two clinical trials for safety and immunogenicity in Flavivirus-naive participants (NCT01477580 and NCT0093642). Here, we report on a randomized, placebo-controlled, double-blind study of the safety and immunogenicity of the V180 vaccine in subjects who have previously received the live attenuated tetravalent vaccine (LATV) developed by the National Institute of Allergy and Infectious Diseases (protocol #V180-002 [CIR-301]). The study was designed to evaluate whether this recombinant subunit vaccine could boost the neutralizing antibody responses induced by dengue LATV. Twenty participants who had previously received one or two doses of dengue LATV were randomized and received a single dose of V180 nonadjuvanted (N = 8), V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) (N = 8), or placebo (N = 4). Immunogenicity was measured using a plaque reduction neutralization test at days 1, 15, 28, and 180 after vaccination. In addition, vaccine safety (solicited and unsolicited adverse events) was assessed using a vaccination report card for 28 days following vaccination, and serious adverse events were captured from the time of informed consent through the final study visit at 6 months after vaccination. The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.

UI	MeSH Term	Description	Entries
D007117	Immunization, Secondary	Any immunization following a primary immunization and involving exposure to the same or a closely related antigen.	Immunization, Booster,Revaccination,Secondary Immunization,Booster Immunization,Booster Immunizations,Immunizations, Booster,Immunizations, Secondary,Revaccinations,Secondary Immunizations
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009500	Neutralization Tests	The measurement of infection-blocking titer of ANTISERA by testing a series of dilutions for a given virus-antiserum interaction end-point, which is generally the dilution at which tissue cultures inoculated with the serum-virus mixtures demonstrate cytopathology (CPE) or the dilution at which 50% of test animals injected with serum-virus mixtures show infectivity (ID50) or die (LD50).	Neutralization Test,Test, Neutralization,Tests, Neutralization
D003715	Dengue	An acute febrile disease transmitted by the bite of AEDES mosquitoes infected with DENGUE VIRUS. It is self-limiting and characterized by fever, myalgia, headache, and rash. SEVERE DENGUE is a more virulent form of dengue.	Dengue Fever,Break-Bone Fever,Breakbone Fever,Classical Dengue,Classical Dengue Fever,Break Bone Fever,Classical Dengue Fevers,Classical Dengues,Dengue Fever, Classical,Dengue, Classical,Fever, Break-Bone,Fever, Breakbone,Fever, Dengue
D003716	Dengue Virus	A species of the genus FLAVIVIRUS which causes an acute febrile and sometimes hemorrhagic disease in man. Dengue is mosquito-borne and four serotypes are known.	Breakbone Fever Virus,Breakbone Fever Viruses,Dengue Viruses,Fever Virus, Breakbone,Fever Viruses, Breakbone,Virus, Breakbone Fever,Virus, Dengue,Viruses, Breakbone Fever,Viruses, Dengue
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000071497	Immunogenicity, Vaccine	The capacity of VACCINES to stimulate the ADAPTIVE IMMUNE RESPONSE to produce antibodies and antigen-specific T-CELL responses. It is typically measured in vaccinated individuals in observational studies setting.	Antigenicity, Vaccine,Vaccine Antigenicity,Vaccine Immunogenicity