Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion criteria * Has voluntarily signed the written informed consent * Male or female aged ≥18 to ≤75 years * Good general health based upon the results of the medical history, laboratory tests, physical examination, ENT clinical examination, and vital signs as assessed by the investigator * Prior vaccination with at least two doses of any COVID-19 vaccine with last dose obtained ≥180 days before the planned baseline (Day 0) visit * Has a personal smartphone, tablet or computer with internet access, and is considered willing and able to report the data in the ePRO and to comply with the reporting timelines * Willing and able to comply with the instructions to participants * Not of childbearing potential or willing and able to use a highly effective contraception method consistently and correctly during the entire trial Exclusion criteria * Pregnant, planning to become pregnant, or breastfeeding women * Received any investigational drug \< 180 days prior baseline * Antigen positivit