Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9–50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study

Coronel-Martinez, Diana Leticia; Park, Juliana; López‐Medina, Eduardo; Capeding, María Rosario; Bonfanti, Andrés Angelo Cadena; Montalbán, María Cecilia; Ramírez, Isabel; Gonzales, Maria; DiazGranados, Carlos A.; Zambrano, Betzana; Dayan, Gustavo H.; Savarino, Stephen J.; Chen, Zhenghong; Wang, Hao; Sun, Han; Bonaparte, Matthew; Rojas, Andrey; Ramírez, Jenny Carolina; Verdan, Mae Ann; Noriega, Fernando

doi:10.1016/s1473-3099(20)30767-2

Cited by 13 publications

(11 citation statements)

References 30 publications

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“…These data suggest similar protection against disease even after a single dose (55). Antibody responses at 28 days and 1 year in a 1-dose or 2-dose regimen were noninferior compared with a 3-dose regimen against all serotypes in seropositive persons aged 9-50 years (56). These data might lead to a recommendation of a simplified dose schedule in the future.…”

Section: Vaccine Efficacymentioning

confidence: 65%

Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021

Paz–Bailey¹,

Adams²,

Wong³

et al. 2021

MMWR Recomm. Rep.

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Dengue is a vectorborne infectious disease caused by dengue viruses (DENVs), which are predominantly transmitted by Aedes aegypti and Aedes albopictus mosquitos. Dengue is caused by four closely related viruses (DENV-1-4), and a person can be infected with each serotype for a total of four infections during their lifetime. Areas where dengue is endemic in the United States and its territories and freely associated states include Puerto Rico, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau. This report summarizes the recommendations of the Advisory Committee on Immunization Practices (ACIP) for use of the Dengvaxia vaccine in the United States. The vaccine is a live-attenuated, chimeric tetravalent dengue vaccine built on a yellow fever 17D backbone. Dengvaxia is safe and effective in reducing dengue-related hospitalizations and severe dengue among persons who have had dengue infection in the past. Previous natural infection is important because Dengvaxia is associated with an increased risk for severe dengue in those who experience their first natural infection (i.e., primary infection) after vaccination. Dengvaxia was licensed by the Food and Drug Administration for use among children and adolescents aged 9-16 years (referred to in this report as children). ACIP recommends vaccination with Dengvaxia for children aged 9-16 having evidence of a previous dengue infection and living in areas where dengue is endemic. Evidence of previous dengue infection, such as detection of anti-DENV immunoglobulin G with a highly specific serodiagnostic test, will be required for eligible children before vaccination.

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Section: Vaccine Efficacymentioning

confidence: 65%

Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021

Paz–Bailey¹,

Adams²,

Wong³

et al. 2021

MMWR Recomm. Rep.

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“…A 2-dose CYD-TDV regimen may be an alternative in individuals who are dengue seropositive at baseline and ages 9 years and older. 54 Although the dengue vaccine is needed for travelers entering endemic areas, there is limited practical use for the CYD-TDV due to the limited number of seropositive travelers and the long vaccination schedule of 3 doses 6 months apart. 55 Several other dengue vaccine candidates, including live, attenuated; purified inactivated; subunit; and DNA vaccines, currently are under clinical development ( Table 1 ).…”

Section: Denguementioning

confidence: 99%

Prevention of Emerging Infections in Children

Puthanakit

Anugulruengkitt

Jantarabenjakul

2022

Pediatric Clinics of North America

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“…In a randomized, controlled, phase II, non-inferiority study of CYD-TDV in healthy individuals aged 9–50 years, the one- and two-dose groups were compared to the three-dose group. The two-dose CYD-TDV regimen was revealed as an alternative to the licensed three-dose regimen in seropositive subjects at baseline and aged 9 years and older ( Coronel-Martinez et al, 2021 ). Moreover, in low-resource settings, vaccination with a reduced number of doses may lead to improved vaccine compliance and coverage.…”

Section: Denv Vaccines Under Developmentmentioning

confidence: 99%

Recent Insights Into the Molecular Mechanism of Toll-Like Receptor Response to Dengue Virus Infection

2021

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Dengue is the most prevalent and rapidly spreading mosquito-borne viral disease caused by dengue virus (DENV). Recently, DENV has been affecting humans within an expanding geographic range due to the warming of the earth. Innate immune responses play a significant role in antiviral defense, and Toll-like receptors (TLRs) are key regulators of innate immunity. Therefore, a detailed understanding of TLR and DENV interactions is important for devising therapeutic and preventive strategies. Several studies have indicated the ability of DENV to modulate the TLR signaling pathway and host immune response. Vaccination is considered one of the most successful medical interventions for preventing viral infections. However, only a partially protective dengue vaccine, the first licensed dengue vaccine CYD-TDV, is available in some dengue-endemic countries to protect against DENV infection. Therefore, the development of a fully protective, durable, and safe DENV vaccine is a priority for global health. Here, we demonstrate the progress made in our understanding of the host response to DENV infection, with a particular focus on TLR response and how DENV avoids the response toward establishing infection. We also discuss dengue vaccine candidates in late-stage development and the issues that must be overcome to enable their success.

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Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9–50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study

Cited by 13 publications

References 30 publications

Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021

Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021

Prevention of Emerging Infections in Children

Recent Insights Into the Molecular Mechanism of Toll-Like Receptor Response to Dengue Virus Infection

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