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Abstract
We evaluated the safety and immunogenicity of two doses of a live-attenuated, tetravalent dengue virus vaccine (F17/Pre formulation) and a booster dose in a dengue endemic setting in two studies. Seven children (7- to 8-year-olds) were followed for 1 year after dose 2 and then given a booster dose (F17/Pre formulation), and followed for four more years (Child study). In the Infant study, 49 2-year-olds, vaccinated as infants, were followed for approximately 3.5 years after dose 2 and then given a booster dose (F17) and followed for one additional year. Two clinically notable events were observed, both in dengue vaccine recipients in the Infant study: 1 case of dengue approximately 2.7 years after dose 2 and 1 case of suspected dengue after booster vaccinations. The booster vaccinations had a favorable safety profile in terms of reactogenicity and adverse events reported during the 1-month follow-up periods. No vaccine-related serious adverse events were reported during the studies. Neutralizing antibodies against dengue viruses 1–4 waned during the 1–3 years before boosting, which elicited a short-lived booster response but did not provide a long-lived, multivalent antibody response in most subjects. Overall, this candidate vaccine did not elicit a durable humoral immune response.
Highlights
Dengue, the most common global arthropod-borne viral disease, is caused by any of four dengue viruses (DENV 1–4), single-stranded RNA viruses of the genus Flavivirus.The burden of dengue has increased over the past decades with an estimated annual global incidence of 100 million symptomatic cases including 1 million severe cases and 21,000 deaths.[1,2] Close to 75% of the global disease burden of dengue is found in the southeast Asia and the Western Pacific regions.[3]
Additional studies in larger cohorts will be required to evaluate the effect of prior administration of live-attenuated dengue vaccine with subsequent immunization by inactivated Japanese encephalitis virus (JEV) vaccine. In these two follow-up studies of children and infants who were primed with two doses of DENV vaccine and given a booster dose 1–3 years later, we failed to detect long-lived, multivalent anti-DENV neutralizing antibody in most subjects
DENV infection occurred in some control subjects as indicated by otherwise unexplained antiDENV antibody titer increases, only a single case of dengue illness in a vaccine recipient led to hospitalization
Summary
The most common global arthropod-borne viral disease, is caused by any of four dengue viruses (DENV 1–4), single-stranded RNA viruses of the genus Flavivirus.The burden of dengue has increased over the past decades with an estimated annual global incidence of 100 million symptomatic cases including 1 million severe cases and 21,000 deaths.[1,2] Close to 75% of the global disease burden of dengue is found in the southeast Asia and the Western Pacific regions.[3]. Development of effective tetravalent dengue vaccines is a high public health priority in endemic regions.[6] The U.S Army Medical Research and Materiel Command (USAMRMC) in partnership with GSK Vaccines in Belgium developed a liveattenuated, tetravalent DENV vaccine as four separate monovalent vaccines (DENV-1, -2, -3, and -4) that were mixed before administration This candidate vaccine, DENV F17/ Pre formulation (referred to as F17/Pre hereafter), was previously described.[7] The F17/Pre vaccine was found to be well tolerated and immunogenic in a phase 2 trial involving U.S adult volunteers.[8] The vaccine was further tested in two phase 1/2 clinical trials in Bangkok, Thailand: one small study in healthy children 6–7 years of age[8] and the other in healthy infants 12–15 months of age.[9]
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