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NOT YET RECRUITING
NCT06973772
PHASE3

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

View on ClinicalTrials.gov

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

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

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