This is a Phase 1a, single-country, single-centre, single-blinded, COV2 vaccine formulation randomized trial designed to investigate and compare the safety and immunogenicity of two COV2 vaccine formulations. COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2 spike protein. Participants will receive one of the two COV2 formulations in two doses on Day 0 and Day 28. This trial consists of two parts; Part 1 is a vaccination phase assessing safety and immunogenicity and Part 2 is a long-term immunogenicity follow-up assessing persistence of immune response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
20
COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.
COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.
Kuopio University Hospital, ENT policlinic
Kuopio, Northern Savonia, Finland
RECRUITINGPrimary safety endpoints
Incidence of Treatment-emergent expected and unexpected adverse events
Time frame: From Day 0 to day 56
Primary immunogenicity endpoint
The percentage of participants achieving ≥2-fold rise (seroresponse) in SARS-CoV-2 serum neutralizing antibody (NAb) titers against Omicron BA.5 variant
Time frame: Day 56 from baseline
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