Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study
Issued Date
2022-05-01
Resource Type
ISSN
00221899
eISSN
15376613
Scopus ID
2-s2.0-85092636770
Pubmed ID
32658250
Journal Title
Journal of Infectious Diseases
Volume
225
Issue
9
Start Page
1513
End Page
1520
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Infectious Diseases Vol.225 No.9 (2022) , 1513-1520
Suggested Citation
Sirivichayakul C., Barranco-Santana E.A., Rivera I.E., Kilbury J., Raanan M., Borkowski A., Papadimitriou A., Wallace D. Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study. Journal of Infectious Diseases Vol.225 No.9 (2022) , 1513-1520. 1520. doi:10.1093/infdis/jiaa406 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/85950
Title
Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study
Other Contributor(s)
Abstract
Background: 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. Methods: 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. Results: 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. Conclusions: 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.