Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRokote Laboratories Finland Oy
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnant, planning to become pregnant, or breastfeeding women
Received any investigational drug < 180 days prior baseline
Antigen positivity or PCR confirmed SARS-CoV-2 infection less than 180 days apart from screening or during screening and/or baseline
Any SARS-CoV vaccination was administrated < 180 days prior the planned baseline (Day 0) visit
Trial design
Design model
Parallel
Treatments tested in this trial
COVID-19 Vaccines
Biological/VaccineCOV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.
COVID-19 Vaccines
Biological/VaccineCOV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: COV2 vaccine in Formulation AExperimental treatment 1 intervention
Group B: COV2 vaccine in formulation BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary safety endpoints
Incidence of Treatment-emergent expected and unexpected adverse events
Time frame
From Day 0 to day 562
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 baselineSponsors and contacts
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Source ClinicalTrials.gov