Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial

@article{Biswal2020EfficacyOA,
  title={Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial},
  author={Shibadas Biswal and Charissa Fay Corazon Borja-Tabora and Luis Martinez Vargas and Hector Vel{\'a}squez and Maria Theresa Alera and Victor Y. Sierra and Edith Johana Rodriguez-Arenales and Delia Yu and Vithanage Pujitha Wickramasinghe and Edson Duarte Moreira and Asvini D. Fernando and Dulanie Gunasekera and Pope Kosalaraksa and F{\'e}lix Espinoza and Eduardo L{\'o}pez-Medina and Lulu C. Bravo and Suely Hiromi Tuboi and Yanee Hutagalung and Pedro Garbes and Ian Escudero and Martina Rauscher and Svetlana Bizjajeva and Inge Lefevre and Astrid Borkowski and Xavier S{\'a}ez-Llorens and Derek Wallace and Alys Concepci{\'o}n and Ana Cecilia Villarreal and Asvini D. Fernando and Chukiat Sirivichayakul and Edith Johana Rodriguez-Arenales and Humberto Reynales and Kleber Giovanni Luz and Jose ¤ Jimeno and Lakkumar Fernando and Luis Rivera and Onanong Manacharoen and Pio L{\'o}pez and Vithanage Pujitha Wickramasinghe and Reynaldo Dietze and Rivaldo Ven{\^a}ncio da Cunha and Veerachai Watanaveeradej and M Brose and Kelley J Moss and Seetha Meyer and Vianney Tricou},
  journal={The Lancet},
  year={2020},
  volume={395},
  pages={1423-1433}
}
View on Elsevier
arca.fiocruz.br
66 Citations
Highly Influential Citations
5
Background Citations
19
Methods Citations
3
Results Citations
3

Figures and Tables from this paper

66 Citations

Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17 years: a randomised, placebo-controlled, phase 2 trial

Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study

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.

Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naïve adolescents in Mexico City

TAK-003 was immunogenic against all four serotypes and was well tolerated in dengue-naïve adolescents living in Mexico City, an area considered non-endemic for d Dengue.

Current Development and Challenges of Tetravalent Live-Attenuated Dengue Vaccines

This review focuses on the designs and evaluation of TAK-003 and TV003 vaccine candidates in humans in comparison to the licensed CYD-TDV vaccine, and highlights specific lessons from existing studies and challenges that must be overcome to develop a dengue vaccine that confers effective and balanced protection against all four DENV serotypes but with minimal adverse effects.

A phase I randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus-experienced healthy adults

Data from this phase 1 double-blind, placebo-controlled study support further development of V181 as a single-dose vaccine for the prevention of dengue disease.

Targets and strategies for vaccine development against dengue viruses.

Dengue Vaccines: An Update

At least seven DENV vaccines have undergone different phases of clinical trials; however, only three have showed promising results, and are addressed in detail in this review in terms of their molecular design, efficacy, and immunogenicity.

Defining levels of dengue virus serotype-specific neutralizing antibodies induced by a live attenuated tetravalent dengue vaccine (TAK-003)

The results indicate that the presence of neutralizing antibodies alone are not a reliable indicator of the immunogenicity of each vaccine component, and concludes that the DENV2 component in the vaccine is immunodominant because of the high levels of serumneutralizing antibodies targeting type-specific epitopes.

Efficacy of Tetravalent Dengue Vaccine: A Systematic Review and Meta-Analysis

Dengue is one of the neglected tropical diseases caused by flavivirus and live-attenuated tetravalent vaccine is launched for the age group of 9–45 years, and its efficacy and adverse effects following immunization are reviewed.

Dengue vaccine: an update

The lack of an ideal animal model is an obstacle to the development of dengue vaccines, and the macaque model may be considered for similar immunologic responses in humans.
...

References

SHOWING 1-10 OF 33 REFERENCES

Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17 years: a randomised, placebo-controlled, phase 2 trial

Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Healthy Children and Adults in Dengue-Endemic Regions: A Randomized, Placebo-Controlled Phase 2 Study.

Injection site pain, itching, and erythema were the only solicited adverse events more frequently reported with TDV than with placebo in all age groups, and TDV was well tolerated and immunogenic in volunteers aged 1.5-45 years, irrespective of prevaccination dengue exposure.

Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial

Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents.

TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic and the incidence of serious adverse events was similar in the vaccine group and placebo group.

Safety and Immunogenicity of a Recombinant Tetravalent Dengue Vaccine in 9–16 Year Olds: A Randomized, Controlled, Phase II Trial in Latin America

CYD-TDV had a favorable safety profile and elicited antibody responses against all 4 dengue virus serotypes in 9–16 year olds in Latin America, and these findings support the continued development of CYD- TDV.

Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study.

Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study.

Safety and immunogenicity of different doses and schedules of a live attenuated tetravalent dengue vaccine (TDV) in healthy adults: A Phase 1b randomized study.

Safety and Immunogenicity of a Live Attenuated Tetravalent Dengue Vaccine Candidate in Flavivirus-Naive Adults: A Randomized, Double-Blinded Phase 1 Clinical Trial.

TDV was generally well tolerated, induced trivalent or broader neutralizing antibodies to DENV in most flavivirus-naive vaccinees, and is undergoing further development.

Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy

CYD‐TDV protected against severe VCD and hospitalization for VCD for 5 years in persons who had exposure to dengue before vaccination, and there was evidence of a higher risk of these outcomes in vaccinated people who had not been exposed to d Dengue.