Status and phase
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About
A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate. All participants who receive two doses of the vaccine candidate will be invited to participate in the Booster phase.
Full description
The multicenter, dose finding Phase 1/2 study starts off with an open-label, dose-escalation part, thereafter, during the double-blind part of study, participants will be randomized 1:1:1 to receive the low, medium or high dose of the vaccine (VLA2001). All participants will received a total of two vaccinations intramuscularly, on day 1 and day 22.
The first 5 participants in each dose group will receive VLA2001 open label, starting with the low dose of VLA2001. If no safety concerns are identified, the next 5 subjects will receive the medium dose of the vaccine. Again, if no safety issues are identified, 5 participants will be vaccinated with the high dose of the vaccine. A Data Safety and Monitoring Board (DSMB) will review accrued safety data before randomization of the remaining 135 subjects across all sites will be initiated.
All study participants will be followed up for safety and immunogenicity up to approximately 6 months after receiving their second vaccination.
This study was extended to investigate the tolerability, safety and immungenicity of a booster vaccination with VLA2001. All study participants, in the Booster phase, will be followed up for safety and immunogenicity up to 6 months after receiving their Booster vaccination.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria - Subjects who meet ALL of the following criteria are eligible for the study:
Participant is 18 to 55 years of age
Participant who has a smart phone and is willing and able to install and use the eDiary.
Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures.
Participant is generally healthy as determined by the Investigator
Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2
If subject is of childbearing potential:
Inclusion Criteria for Booster Phase - Subjects who meet ALL of the following criteria are eligible for the Booster phase:
B1. Participant has received complete VLA2001 primary immunization (two vaccinations according to the protocol)
B2. Participant who has a smart phone and is willing and able to install and use the e-Diary.
B3. Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures.
B4. Participant is generally healthy as determined by the Investigator's clinical judgement
B5. If a participant is of childbearing potential:
Exclusion criteria - Participants who meet ANY of the following criteria are NOT eligible for this study:
Exclusion Criteria for Booster Phase - Participants who meet ANY of the following criteria are NOT eligible for Booster phase:
Primary purpose
Allocation
Interventional model
Masking
153 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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