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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.

NCT06973772 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-03-06

No results posted yet for this study

Summary

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.

Conditions

  • Dengue
  • Chikungunya

Interventions

BIOLOGICAL

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

DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular

BIOLOGICAL

DENGUE: Dengue 1,2,3,4 (attenuated) vaccine

DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous

BIOLOGICAL

Chikungunya (CHIKV) live attenuated vaccine (VLA1555)

CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular

Sponsors & Collaborators

  • Butantan Institute

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-07-31
Completion
2026-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06973772 on ClinicalTrials.gov