In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).
In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724) These participants will have annual follow-up visits at Months 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 after immunization. The primary objective of this trial will be to evaluate persistence of antibodies annually from 1 to 10 years after the single immunization with VLA1553. The secondary objective is to evaluate long-term safety 6 months to 2 years after the single immunization with VLA1553.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
363
Trial participants previously vaccinated with VLA1553 in trial VLA1553-301 will be followed up for safety and immunogenicity.
Accelerated Enrollment Solutions (AES)
Phoenix, Arizona, United States
Velocity Clinical Research
Hallandale, Florida, United States
Accelerated Enrollment Solutions (AES)
Chicago, Illinois, United States
Proportion of Participants With Seroresponse Levels Post-vaccination. (Defined as µPRNT50 ≥150)
Data for Visit 1 - Day 1 are collected from Trial VLA1553-301
Time frame: Year 2
Frequency of Any Serious Adverse Event (SAE)
Time frame: until Year 2
Relatedness of Any Serious Adverse Event (SAE)
Time frame: until Year 2
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers Post-vaccination
Time frame: until Year 10
Proportion of Participants With Seroconversion
Time frame: until Year 10
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Post-vaccination as Compared to Baseline (i.e. at Start of Trial VLA1553-301)
Time frame: until Year 10
Proportion of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline
Time frame: until Year 10
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Alliance for Multispecialty Research (AMR)
Lexington, Kentucky, United States
Velocity Clinical Research
Grand Island, Nebraska, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Alliance for Multispecialty Research (AMR)
Knoxville, Tennessee, United States
Velocity Clinical Research
Austin, Texas, United States
Velocity Clinical Research
West Jordan, Utah, United States
Allliance for Multispecialty Research (AMR)
Norfolk, Virginia, United States