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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).
Financial support: This work was funded by US Army Medical Research and Materiel Command (Fort Detrick, MD) and GlaxoSmithKline (Rixensart, Belgium).
Authors' addresses: Veerachai Watanaveeradej, Sriluck Simasathien, Rudiwilai Samakoses, and Angkool Kerdpanich, Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand, E-mails: firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, and email@example.com. Ananda Nisalak, Richard G. Jarman, Stephen J. Thomas, Robert V. Gibbons, and Sumetha Hengprasert, Department of Virology, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand, E-mails: firstname.lastname@example.org, email@example.com, Stephen.firstname.lastname@example.org, Robert.email@example.com, and firstname.lastname@example.org. Timothy P. Endy, Infectious Disease Division, Department of Medicine, State University of New York, Upstate Medical University, Syracuse, NY, E-mail: email@example.com. Bruce L. Innis and David W. Vaughn, GlaxoSmithKline, King of Prussia, PA, E-mails: firstname.lastname@example.org and email@example.com. J. Robert Putnak, Division of Viral Diseases, Walter Reed Army Institute of Research, Silver Spring, MD, E-mail: firstname.lastname@example.org. Kenneth H. Eckels and Rafael De La Barrera, Pilot Bioproduction Facility, Division of Regulated Activities, Walter Reed Army Institute of Research, Silver Spring, MD, E-mails: email@example.com and firstname.lastname@example.org. Mammen P. Mammen Jr., ATTN: Dengue Product Manager, Pharmaceutical Systems Program Management Office, U.S. Army Medical Materiel Development Activity, Fort Detrick, MD, E-mail: email@example.com.