The main purpose of the study is to evaluate the safety and immunogenicity of SPYVLP01 in two different doses with and without adjuvants in healthy adults aged 18-50 years old.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Novel vaccine SPYVLP01
Velocity Bristol
Bristol, United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom
To assess the safety profile of the vaccine with and without adjuvants
The specific endpoints for safety will be actively and passively collected data on Adverse Events (AEs). The following parameters will be assessed: * Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following each vaccination * Occurrence of unsolicited AEs for 28 days following each vaccination * Change from baseline for safety laboratory measures for 28 days following each vaccination * Occurrence of Serious Adverse Events (SAEs) during the whole study duration * Occurrence of Adverse events of special interest (AESIs) during the whole study duration
Time frame: ongoing for 12 months
To assess the reactogenicity profile of the vaccine with and without adjuvants
The specific endpoints for reactogenicity will be actively and passively collected data on AEs. The following parameters will be assessed: * Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following each vaccination * Occurrence of unsolicited AEs for 28 days following each vaccination * Change from baseline for safety laboratory measures for 28 days following each vaccination * Occurrence of SAEs during the whole study duration * Occurrence of AESIs during the whole study Duration
Time frame: ongoing for 12 months
To investigate the pentamer specific binding antibodies and neutralizing antibodies solicited by each arm in seropositive and seronegative healthy male and female adult volunteers
Pentamer-specific immunogenicity will be assessed by a variety of immunological assays.
Time frame: ongoing for 12 months
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