Biomaterial Database

Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus-naive infants. 2011

Veerachai Watanaveeradej, and Sriluck Simasathien, and Ananda Nisalak, and Timothy P Endy, and Richard G Jarman, and Bruce L Innis, and Stephen J Thomas, and Robert V Gibbons, and Sumetha Hengprasert, and Rudiwilai Samakoses, and Angkool Kerdpanich, and David W Vaughn, and J Robert Putnak, and Kenneth H Eckels, and Rafael De La Barrera, and Mammen P Mammen

Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand. veerachaiw@yahoo.com

A Phase I/II observer-blind, randomized, controlled trial evaluated the safety and immunogenicity of a dengue virus (DENV) vaccine candidate in healthy Thai infants (aged 12-15 months) without measurable pre-vaccination neutralizing antibodies to DENV and Japanese encephalitis virus. Fifty-one subjects received two doses of either DENV (N = 34; four received 1/10th dose) or control vaccine (N = 17; dose 1, live varicella; dose 2, Haemophilus influenzae type b). After each vaccine dose, adverse events (AEs) were solicited for 21 days, and non-serious AEs were solicited for 30 days; serious AEs (SAEs) were recorded throughout the study. Laboratory safety assessments were performed at 10 and 30 days; neutralizing antibodies were measured at 30 days. The DENV vaccine was well-tolerated without any related SAEs. After the second dose, 85.7% of full-dose DENV vaccinees developed at least trivalent and 53.6% developed tetravalent neutralizing antibodies ≥ 1:10 to DENV (control group = 0%). This vaccine candidate, therefore, warrants continued development in this age group (NCT00322049; clinicaltrials.gov).

UI	MeSH Term	Description	Entries
D007115	Immunization Schedule	Schedule giving optimum times usually for primary and/or secondary immunization.	Immunization Schedules,Schedule, Immunization,Schedules, Immunization
D007223	Infant	A child between 1 and 23 months of age.	Infants
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
D004672	Encephalitis, Japanese	A mosquito-borne encephalitis caused by the Japanese B encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE) occurring throughout Eastern Asia and Australia. The majority of infections occur in children and are subclinical or have features limited to transient fever and gastrointestinal symptoms. Inflammation of the brain, spinal cord, and meninges may occur and lead to transient or permanent neurologic deficits (including a POLIOMYELITIS-like presentation); SEIZURES; COMA; and death. (From Adams et al., Principles of Neurology, 6th ed, p751; Lancet 1998 Apr 11;351(9109):1094-7)	Encephalitis, Japanese B,Japanese Encephalitis,Japanese B Encephalitis,Japanese B Viral Encephalitis,Viral Encephalitis, Japanese B
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014613	Vaccines, Attenuated	Live vaccines prepared from microorganisms which have undergone physical adaptation (e.g., by radiation or temperature conditioning) or serial passage in laboratory animal hosts or infected tissue/cell cultures, in order to produce avirulent mutant strains capable of inducing protective immunity.	Attenuated Vaccine,Vaccines, Live, Attenuated,Attenuated Vaccines,Vaccine, Attenuated
D053059	Dengue Vaccines	Vaccines or candidate vaccines used to prevent infection with DENGUE VIRUS. These include live-attenuated, subunit, DNA, and inactivated vaccines.	Dengue Tetravalent Vaccine, Live,Dengue Vaccine,Dengvaxia,Dengvaxia Vaccine,Tetravalent Dengue Vaccine,Dengue Vaccine, Tetravalent,Vaccine, Dengue,Vaccine, Dengvaxia,Vaccine, Tetravalent Dengue,Vaccines, Dengue
D022321	Japanese Encephalitis Vaccines	Vaccines or candidate vaccines used to prevent infection with Japanese B encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE).	Japanese Encephalitis Vaccine,Encephalitis Vaccine, Japanese,Encephalitis Vaccines, Japanese,Vaccine, Japanese Encephalitis,Vaccines, Japanese Encephalitis