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Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study.
- Source :
- Journal of Infectious Diseases; May2022, Vol. 225 Issue 9, p1513-1520, 8p
- Publication Year :
- 2022
-
Abstract
- <bold>Background: </bold>We report long-term safety and immunogenicity of Takeda's tetravalent dengue vaccine candidate (TAK-003) in healthy children and adults living in dengue-endemic areas in Puerto Rico, Columbia, Singapore, and Thailand.<bold>Methods: </bold>In part 1 of this phase 2, randomized, placebo-controlled trial we sequentially enrolled 1.5-45 year olds (n = 148) into 4 age-descending groups, randomized 2:1 to receive 2 doses of TAK-003 or placebo 90 days apart. In part 2, 1-11 year olds (n = 212) were enrolled and randomized 3:1 to TAK-003 or placebo groups. We assessed neutralizing antibody titers for the 4 dengue serotypes (DENV) up to month 36 in part 1, and symptomatic dengue and serious adverse events (SAEs) up to month 36 in both parts.<bold>Results: </bold>At month 36, seropositivity rates were 97.3%, 98.7%, 88.0% and 56.0% for DENV-1, -2, -3 and -4, respectively. Seropositivity rates varied significantly for DENV-4 according to serostatus at baseline (89.5% in seropositives versus 21.6% in seronegatives). No vaccine-related SAEs were reported.<bold>Conclusions: </bold>The trial demonstrated persistence of neutralizing antibody titers against TAK-003 over 3 years in children and adults living in dengue-endemic countries, with limited contribution from natural infection. TAK-003 was well tolerated.<bold>Clinical Trials Registration: </bold>NCT01511250. [ABSTRACT FROM AUTHOR]
- Subjects :
- VACCINATION of children
IMMUNE response
DENGUE
CLINICAL trial registries
ANTIBODY titer
RESEARCH
VIRAL vaccines
IMMUNOGLOBULINS
VACCINES
CLINICAL trials
FLAVIVIRUSES
RESEARCH methodology
EVALUATION research
COMBINED vaccines
COMPARATIVE studies
RANDOMIZED controlled trials
RESEARCH funding
VIRAL antibodies
Subjects
Details
- Language :
- English
- ISSN :
- 00221899
- Volume :
- 225
- Issue :
- 9
- Database :
- Complementary Index
- Journal :
- Journal of Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 156677870
- Full Text :
- https://doi.org/10.1093/infdis/jiaa406