Chikungunya Clinical Trial
Official title:
A Multicenter, Randomized, Controlled, Double Blinded Pivotal Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Adolescents Aged 12 Years to <18 Years
This is a prospective, randomized, double-blinded, multicenter, pivotal study evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The final dose of VLA1553 or control will be administered as single immunization on Day 1. Overall, approximately 750 male and female subjects aged 12 years to <18 years will be enrolled into the study.
This is a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 study comprising approximately 750 subjects aged 12 years to <18 years randomized in a 2:1 ratio to the live-attenuated CHIKV vaccine candidate (VLA1553) or placebo. The final dose of lyophilized VLA1553 or placebo will be administered as a single intramuscular immunization. Subjects in this study will be stratified by baseline serostatus. The primary objective of the study is to evaluate the immunogenicity and safety of the adult dose of VLA1553 28 days following the single immunization. Immunogenicity evaluations in the immunogenicity subset will include the proportion of subjects with seroprotective neutralizing CHIKV antibody titers above a surrogate threshold indicative of protection. The surrogate of protection reasonably likely to predict clinical benefit has been established in non-human primate passive transfer studies using human sera from the Phase 1 study. Safety data collection and immunogenicity will continue to be assessed until Month 12. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
| Completed |
NCT04440774 -
Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico.
|
Phase 1 | |
| Completed |
NCT05153018 -
Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu
|
N/A | |
| Active, not recruiting |
NCT04343521 -
Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases
|
Phase 3 | |
| Completed |
NCT03992872 -
Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)
|
Phase 2 | |
| Completed |
NCT03382964 -
Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02831699 -
The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico
|
||
| Recruiting |
NCT01099852 -
Cohort of Patients Infected by an Arbovirus
|
||
| Completed |
NCT06257810 -
Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa
|
Phase 4 | |
| Suspended |
NCT05218304 -
Baromètre Santé Adulte 2021-2022
|
N/A | |
| Recruiting |
NCT04615364 -
Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia
|
||
| Not yet recruiting |
NCT04672577 -
Infection Tracking in Travellers. The Project Aims to Identify Profiles of Travel-associated Illness and to Follow up on Long-term Sequelae of Arboviral Infections and Malaria
|
||
| Completed |
NCT04434846 -
Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia
|
||
| Recruiting |
NCT04838574 -
Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years
|
||
| Recruiting |
NCT04619823 -
Virological and Immunological Determinants of Arbovirus Infection in New Caledonia
|
N/A | |
| Completed |
NCT03101111 -
Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area
|
Phase 2 | |
| Completed |
NCT02463968 -
Chikungunya Arthritis in the Americas
|
N/A | |
| Active, not recruiting |
NCT04566484 -
Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia
|
Phase 2/Phase 3 | |
| Completed |
NCT04603131 -
Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine
|
Phase 1 |