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.
- Conditions
- DengueChikungunya
- Interventions
- Biological: Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
- Registration Number
- NCT06973772
- Lead Sponsor
- Butantan Institute
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 900
- 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.
- 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.
- Thrombocytopenia or bleeding disorders that contraindicate intramuscular vaccination or venipuncture for blood collection.
- Receipt of immunoglobulins, blood, or blood products within 180 days prior to screening.
- Altered immunocompetence (immunosuppression, immunodeficiency, or immunocompromise) primary or secondary due to: Clinical conditions (including but not limited to renal failure, liver failure with cirrhosis, heart failure class III or IV according to the New York Heart Association, HIV infection, and asplenia).
- Use of systemic corticosteroids (oral, intravenous, or intramuscular) at a dose equivalent to ≥20 mg/day of prednisone for more than 14 days or a cumulative dose greater than 280 mg within the last 90 days prior to screening. Topical, inhaled, and intranasal corticosteroids are allowed. Intermittent use (a single dose within the last 30 days prior to screening) of intra-articular corticosteroids is also allowed.
- Receipt of antineoplastic agents, immunosuppressants, immunomodulators, or radiotherapy within the last 180 days prior to screening.
- Malignancy at the time of screening or a history of malignancy with <5 years of disease-free status at screening (except for basal cell carcinoma of the skin and localized prostate cancer under active surveillance).
- Abuse of alcohol and illicit drugs within the past 12 months before screening that may compromise study compliance, at the investigator's discretion.
- Being part of the study team, having a first-degree relative (parents, children, in-laws, stepchildren, sons-in-law, or daughters-in-law) or living in the same household as a study team member.
- Any other clinical condition that, in the investigator's opinion, may interfere with the study results or pose an additional risk to the participant due to study inclusion.
- Prior exposure to dengue and chikungunya viruses, i.e., non-reactive IgM and IgG as screened by specific ELISA for both viruses. In case of doubt or indeterminate ELISA results, at least two consecutive samples will be collected. If doubt persists after two test collections, the participant will be excluded.
- For female participants of childbearing potential: Pregnancy (confirmed by a positive β-hCG test), breastfeeding, or intention to engage in sexual activity with reproductive potential without using a contraceptive method for 90 days following vaccination.
- Previous receipt of any dengue or chikungunya vaccine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chikungunya vaccine only Chikungunya (CHIKV) live attenuated vaccine (VLA1555) A single dose of VLA1555 + placebo, administered concomitantly in opposite arms on Day 1.
- Primary Outcome Measures
Name Time Method Immunogenicity Primary 28 days post-immunization 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.
Safety Primary 21 days post-immunization 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.
- Secondary Outcome Measures
Name Time Method Safety Secondary 1. up to 21 days post-immunization. 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.
Safety Secondary 2. 180 days post-immunization 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.
Safety Secondary 3. Days 1, 6, 9, 16, and 22. Describe post-vaccination viremia cases (manifestations).
Immunogenicity Secondary 1 28 days post-immunization 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.
Immunogenicity Secondary 2. 180 days post-immunization. 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.
Trial Locations
- Locations (7)
Centro Médico de São Francisco
🇧🇷Curitiba, PR, Brazil
Centro de Pesquisa Inova
🇧🇷Toledo, PR, Brazil
Hospital São Vicente de Paulo
🇧🇷Passo Fundo, RS, Brazil
UBEA - União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
🇧🇷Porto Alegre, RS, Brazil
Hospital Escola da Universidade Federal de Pelotas
🇧🇷Pelotas, RS, Brazil
Reumacenter
🇧🇷Porto Alegre, RS, Brazil
Instituto de Pesquisa em AIDS do Estado do Rio Grande do Sul - IPARGS
🇧🇷Porto Alegre, RS, Brazil