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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.
Sponsor: Butantan Institute
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.
Official title: Phase 3b, Multicenter, Randomized, Controlled, Double-Blind Clinical Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines in Adults Aged 18 to 59 Years.
Key Details
Gender
All
Age Range
18 Years - 59 Years
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2026-03-31
Completion Date
2026-10
Last Updated
2026-03-06
Healthy Volunteers
Yes
Conditions
Interventions
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
DENGUE: Dengue 1,2,3,4 (attenuated) vaccine
DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous
Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular
Locations (7)
Centro Médico de São Francisco
Curitiba, Paraná, Brazil
Centro de Pesquisa Inova
Toledo, Paraná, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Escola da Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul, Brazil
Reumacenter
Porto Alegre, Rio Grande do Sul, Brazil
UBEA - União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa em AIDS do Estado do Rio Grande do Sul - IPARGS
Porto Alegre, Rio Grande do Sul, Brazil