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Long-term immunogenicity and safety of tetravalent dengue vaccine (CYD-TDV) in healthy populations in Singapore and Vietnam: 4-year follow-up of randomized, controlled, phase II trials.
- Source :
-
Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2019; Vol. 15 (10), pp. 2315-2327. Date of Electronic Publication: 2019 Mar 20. - Publication Year :
- 2019
-
Abstract
- Dengue is prevalent in the Asia-Pacific region. Participants of two immunogenicity and safety phase II studies conducted in Singapore and Vietnam (NCT0088089 and NCT00875524, respectively) were followed for up to four years after third vaccine dose of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV). Participants (2-45 years) received three doses of CYD-TDV or control at 0, 6, and 12 months. Dengue plaque reduction neutralization test (PRNT <subscript>50</subscript> ) antibody titers were measured in both studies. Cytokine-producing antigen-specific CD4+ and CD8+ T-cells were quantified to assess cell-mediated immunity (CMI) in Singapore. Post-hoc analyses were carried out for participants aged <9 and ≥9 years old. Related and fatal serious adverse events (SAEs) were collected during long-term follow-up. Of participants who received ≥1 CYD-TDV injection in Singapore (n = 1198) and Vietnam (n = 180), 87% and 92% participants completed long-term follow-up, respectively. At four years, geometric mean titers (GMTs) in participants who received CYD-TDV ranged from 30.2 1/dil (95% CI 23.9-38.3) to 73.7 (49.3-110) 1/dil in Vietnam and 9.73 1/dil (95% CI 8.28-11.4) to 21.8 (18.9-25.1) 1/dil in Singapore. Interferon and interleukin-13 levels were lower at four years than one year post-vaccination but were still present. Tumor necrosis factor- α levels at four years were similar to those after the third vaccine dose. Seropositivity rates were higher at year four in participants who were seropositive vs. seronegative at baseline in both studies. No safety concerns were identified. CYD-TDV demonstrated long-term immunogenicity and was well-tolerated for four years after the third vaccine dose.
- Subjects :
- Adolescent
Adult
Antibodies, Neutralizing blood
Antibodies, Viral blood
Child
Child, Preschool
Dengue Virus
Female
Follow-Up Studies
Healthy Volunteers
Humans
Immunity, Cellular
Male
Middle Aged
Singapore
Time Factors
Vaccines, Attenuated immunology
Vietnam
Young Adult
Dengue prevention & control
Dengue Vaccines immunology
Immunogenicity, Vaccine
Subjects
Details
- Language :
- English
- ISSN :
- 2164-554X
- Volume :
- 15
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Human vaccines & immunotherapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 30724660
- Full Text :
- https://doi.org/10.1080/21645515.2019.1578595