Updated
September 28th, 2019

Clinical Trial Suggests 2-dose Dengue Vaccine

Immunogenicity between one versus two doses of Takeda's tetravalent dengue vaccine in children

Several decades of dengue vaccine research have shown how challenging it is to develop a highly efficacious vaccine that protects against all four dengue serotypes for people of all ages.

In light of the rapidly rising incidence of dengue virus infection, now estimated to affect about 100 million individuals per year, the approval of the first dengue vaccine developed by Sanofi Pasteur (CYD-TDV) was a significant achievement.

This clinical trial reported that TDV is safe and immunogenic in individuals aged 2–17 years, irrespective of previous dengue exposure.

However, the first vaccine does not present a simple solution.

According to researchers, this vaccine’s use is made more complex by varying efficacy estimates, and the need to be administered in three doses, six months apart.

A second TDV dose induced enhanced immunogenicity against DENV-3 and DENV-4 in children who were seronegative before vaccination.

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These data supported the initiation of phase 3 evaluation of the efficacy and safety of TDV given in a two-dose schedule 3 months apart.

Dengue is a systemic viral infection transmitted to humans by Aedes mosquitoes. Dengue is associated with a high fever and at least two of the following conditions:

  • Severe headache
  • Severe eye pain (behind eyes)
  • Joint pain
  • Muscle and/or bone pain
  • Rash
  • Mild bleeding manifestation (e.g., nose or gum bleed, petechiae, or easy bruising)
  • Low white cell count

For some patients, dengue is a life-threatening illness. If any of the following occurs after the fever, seek immediate emergency care:

  • Severe abdominal pain or persistent vomiting
  • Red spots or patches on the skin
  • Bleeding from nose or gums
  • Vomiting blood
  • Black, tarry stools (feces, excrement)
  • Drowsiness or irritability
  • Pale, cold, or clammy skin
  • Difficulty breathing

Funding for this research is from Takeda Vaccines.

The researchers did not disclose any conflicts of interest: Prof Xavier Sáez-Llorens, MD, Dr Vianney Tricou, Delia Yu, MD, Luis Rivera, MD, Suely Tuboi, MD, Pedro Garbes, MD, Astrid Borkowski, MD, Derek Wallace, MBBS.