Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines Compared to Separate Administration in Adults Aged 18 to 59 Years.

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-59
SponsorButantan Institute

About this trial

This randomized, controlled, double blind trial aims at assessing the safety and immunogenicity profiles of the co-administered Live Attenuated Dengue and Chikungunya vaccines comparatively to the isolated administration, in the adult population aged 18 to 59 years without prior exposure to either arbovirus.

Eligibility criteria

Qualifiers

Male or female adults aged 18 to 59 years at the time of vaccination.

Signed informed consent by the participant or their legal representatives.

Ability to understand, based on the investigator's assessment, and agree to comply with all study procedures, including blood collection.

Disqualifiers

Participation in another clinical trial within 28 days prior to screening or planned participation in another clinical study during the trial period.

Pre-existing unstable health condition. An unstable health condition is defined as a disease requiring a change in treatment or hospitalization due to disease worsening within 90 days prior to screening.

Vaccination within 14 days prior to screening with any inactivated vaccine or within 28 days prior to screening with any live attenuated vaccine, or planned vaccination with any vaccine up to 28 days after study vaccination.

Known hypersensitivity to any component of the vaccines.

Trial design

Treatments tested in this trial

  • DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
  • DENGUE: Dengue 1,2,3,4 (attenuated) vaccine
  • Chikungunya (CHIKV) live attenuated vaccine (VLA1555)

Treatment groups

900 Participants
are divided into 3 treatment groups

Sponsors and collaborators