CYD Tetravalent Dengue Vaccine Performance by Baseline Immune Profile (Monotypic/Multitypic) in Dengue-Seropositive Individuals
Open Access
- 21 March 2020
- journal article
- research article
- Published by Oxford University Press (OUP) in Clinical Infectious Diseases
- Vol. 72 (10), 1730-1737
- https://doi.org/10.1093/cid/ciaa304
Abstract
The immune profile of dengue-experienced individuals is a determinant of dengue reinfection severity risk. Individuals with a single prior dengue infection (monotypic) are at highest risk for severe disease, while individuals with ≥ 2 prior dengue infections (multitypic) are at lower risk. The tetravalent dengue vaccine (CYD-TDV) has shown efficacy in the prevention of dengue in individuals with prior dengue infection. We estimated efficacy in individuals with monotypic or multitypic immune profiles. Participants enrolled in the immunogenicity subsets of 2 randomized placebo-controlled phase 3 studies (CYD14, NCT01373281; CYD15, NCT01374516) were classified as either monotypic or multitypic, based on measured baseline dengue plaque reduction neutralization test. Vaccine efficacy (VE) against symptomatic virologically confirmed dengue (VCD) was assessed over 25 months and against VCD hospitalization over 6 years. Of 3927 participants in the immunogenicity subsets, 496 and 257 in the CYD-TDV and placebo groups, respectively, were classified as monotypic immune, and 1227 and 612, respectively, as multitypic immune. VE against symptomatic VCD was 77.4% (95% CI, 56.4%–88.2%) for monotypic and 89.2% (95% CI, 71.5%–95.9%) for multitypic profiles, with corresponding absolute risk reductions (ARRs) of 4.48% (95% CI, 2.32%–6.65%) for monotypics and 1.67% (95% CI, .89%–2.46%) for multitypics. VE against hospitalized VCD was 75.3% (95% CI, 42.7%–90.2%) in monotypics and 81.2% (95% CI, 21.7%–96.8%) in multitypics, with ARRs of 0.95% (95% CI, .37%–1.53%) for monotypics and 0.18% (95% CI, .02%–.34%) for multitypics. CYD-TDV benefits individuals with monotypic and multitypic immune profiles. Larger public health benefit is expected to derive from the protection of individuals with a monotypic immune profile.Funding Information
- Sanofi Pasteur
This publication has 26 references indexed in Scilit:
- Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic DiseaseThe New England Journal of Medicine, 2015
- Efficacy of a Tetravalent Dengue Vaccine in Children in Latin AmericaThe New England Journal of Medicine, 2015
- Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trialThe Lancet, 2014
- Reduced Risk of Disease During Postsecondary Dengue Virus InfectionsThe Journal of Infectious Diseases, 2013
- Optimization and Validation of a Plaque Reduction Neutralization Test for the Detection of Neutralizing Antibodies to Four Serotypes of Dengue Virus Used in Support of Dengue Vaccine DevelopmentThe American Journal of Tropical Medicine and Hygiene, 2013
- Dengue Virus Infections in a Cohort of Schoolchildren from Maracay, Venezuela: A 2-Year Prospective StudyVector-Borne and Zoonotic Diseases, 2009
- “Guidelines for the clinical evaluation of dengue vaccines in endemic areas”: Summary of a World Health Organization Technical ConsultationVaccine, 2008
- Guidelines for Plaque-Reduction Neutralization Testing of Human Antibodies to Dengue VirusesViral Immunology, 2008
- Relationship of Preexisting Dengue Virus (DV) Neutralizing Antibody Levels to Viremia and Severity of Disease in a Prospective Cohort Study of DV Infection in ThailandThe Journal of Infectious Diseases, 2004
- Pathogenesis of Dengue: Challenges to Molecular BiologyScience, 1988