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.
A Phase 3b multicenter, randomized, controlled, double-blind clinical trial was designed to evaluate the Immunogenicity (non-inferiority), 28 days post-immunization, for each Dengue and Chikungunya serotypes, as well as the safety, 21 days post-immunization, of the co-administration of the live attenuated Dengue and Chikungunya vaccines compared to the separate administration in adults aged 18 to 59 years without prior exposure to either arbovirus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
900
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: 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
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
Immunogenicity Primary
Demonstrate the non-inferiority of the antibody response of co-administered Dengue and Chikungunya vaccines compared to Dengue and Chikungunya vaccines administered separately, for each Dengue serotype and Chikungunya in the adult population aged 18 to 59 years without prior exposure to either arbovirus, by calculating the Geometric Mean Titer (GMT) and the GMT ratio, post-immunization for each dengue serotype and chikungunya, across all intervention groups.
Time frame: 28 days post-immunization
Safety Primary
Assess the safety profile of co-administered Dengue and Chikungunya vaccines and Dengue and Chikungunya vaccines administered separately, in the adult population aged 18 to 59 years without prior exposure to either arbovirus, through the frequency of participants with solicited (local and systemic) and unsolicited adverse events (AEs), in all intervention groups.
Time frame: 21 days post-immunization
Immunogenicity Secondary 1
Assess the antibody response of co-administered Dengue and Chikungunya vaccines compared to Dengue and Chikungunya vaccines administered separately, in adults aged 18 to 59 years without prior exposure to either arbovirus, comparing the seroconversion rates, for each dengue serotype and chikungunya, across all intervention groups.
Time frame: 28 days post-immunization
Immunogenicity Secondary 2.
Assess the antibody response of co-administered Dengue and Chikungunya vaccines compared to Dengue and Chikungunya vaccines administered separately, in adults aged 18 to 59 years without prior exposure to either arbovirus, comparing the Geometric Mean Titer and the GMT ratio, for each dengue serotype and chikungunya, across all intervention groups.
Time frame: 180 days post-immunization.
Safety Secondary 1.
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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
Describe and compare the safety profile, by listing the Adverse Events of the co-administered Dengue and Chikungunya vaccines and Dengue and Chikungunya vaccines administered separately, reported in adults aged 18 to 59 years without prior exposure to either arbovirus.
Time frame: up to 21 days post-immunization.
Safety Secondary 2.
Describe and compare the safety profile by listing Adverse Events of the co-administered Dengue and Chikungunya vaccines and Dengue and Chikungunya vaccines administered separately, in adults aged 18 to 59 years without prior exposure to either arbovirus.
Time frame: 180 days post-immunization
Safety Secondary 3.
Describe post-vaccination viremia cases (manifestations).
Time frame: Days 1, 6, 9, 16, and 22.