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A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico.

Bauer K, Esquilin IO, Cornier AS, Thomas SJ, Quintero Del Rio AI, Bertran-Pasarell J, Morales Ramirez JO, Diaz C, Carlo S, Eckels KH, Tournay E, Toussaint JF, De La Barrera R, Fernandez S, Lyons A, Sun W, Innis BL - Am. J. Trop. Med. Hyg. (2015)

Bottom Line: No vaccine-related serious adverse events (SAEs) were reported.Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types.The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status.

View Article: PubMed Central - PubMed

Affiliation: Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Department of Molecular Medicine, La Concepcion Hospital, San German, Puerto Rico; Department of Biochemistry, Ponce School of Medicine, Ponce, Puerto Rico; Centro de Reumatologia Pediatrica de Puerto Rico, San Juan, Puerto Rico; Clinical Research Puerto Rico, Inc., San Juan, Puerto Rico; Department of Molecular Medicine, La Concepcion Hospital, San German, Puerto Rico; Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, Maryland; GSK Vaccines, Wavre, Belgium; GSK Vaccines, King of Prussia, Pennsylvania.

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Pre-vaccination priming status, by age (total vaccinated cohort [TVC]).
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Figure 2: Pre-vaccination priming status, by age (total vaccinated cohort [TVC]).

Mentions: The percentage of subjects in the ATP cohort categorized as being primed to DENV (i.e., seropositive to at least one DENV type) at baseline was 51.4%, 60.6%, and 57.7% for the F17, F19, and placebo groups, respectively. Figure 2 shows the distribution of pre-vaccination DENV priming status by age category. Most of the subjects younger than 5 years of age were unprimed to any DENV type prior to receiving the first dose of vaccine or placebo (89.6% of the 12 to 23-month-old subjects and 73.9% of the 2 to 4-year-old subjects). Conversely, the majority of subjects 5 years of age and older were primed to all four DENV types (56.1% of the 5- to 20-year-olds and 88.9% of the 21- to 50-year-olds).


A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico.

Bauer K, Esquilin IO, Cornier AS, Thomas SJ, Quintero Del Rio AI, Bertran-Pasarell J, Morales Ramirez JO, Diaz C, Carlo S, Eckels KH, Tournay E, Toussaint JF, De La Barrera R, Fernandez S, Lyons A, Sun W, Innis BL - Am. J. Trop. Med. Hyg. (2015)

Pre-vaccination priming status, by age (total vaccinated cohort [TVC]).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4559678&req=5

Figure 2: Pre-vaccination priming status, by age (total vaccinated cohort [TVC]).
Mentions: The percentage of subjects in the ATP cohort categorized as being primed to DENV (i.e., seropositive to at least one DENV type) at baseline was 51.4%, 60.6%, and 57.7% for the F17, F19, and placebo groups, respectively. Figure 2 shows the distribution of pre-vaccination DENV priming status by age category. Most of the subjects younger than 5 years of age were unprimed to any DENV type prior to receiving the first dose of vaccine or placebo (89.6% of the 12 to 23-month-old subjects and 73.9% of the 2 to 4-year-old subjects). Conversely, the majority of subjects 5 years of age and older were primed to all four DENV types (56.1% of the 5- to 20-year-olds and 88.9% of the 21- to 50-year-olds).

Bottom Line: No vaccine-related serious adverse events (SAEs) were reported.Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types.The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status.

View Article: PubMed Central - PubMed

Affiliation: Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Department of Molecular Medicine, La Concepcion Hospital, San German, Puerto Rico; Department of Biochemistry, Ponce School of Medicine, Ponce, Puerto Rico; Centro de Reumatologia Pediatrica de Puerto Rico, San Juan, Puerto Rico; Clinical Research Puerto Rico, Inc., San Juan, Puerto Rico; Department of Molecular Medicine, La Concepcion Hospital, San German, Puerto Rico; Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, Maryland; GSK Vaccines, Wavre, Belgium; GSK Vaccines, King of Prussia, Pennsylvania.

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Related in: MedlinePlus