Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19
A Phase 1a, Single-Blind, Randomized Comparative Clinical Trial Evaluating the Impact of Vaccine Formulation on the Safety and Immunogenicity of the COV2 Vaccine in Healthy Adults
Rokote Laboratories Finland Oy
20 participants
Feb 10, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria19
- 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
- Any other vaccination within 60 days prior the planned baseline (Day 0) visit
- Administration of immunoglobulins or blood products within 90 days prior baseline
- Use of steroid nasal sprays within 30 days prior to screening
- Use of any oral or nasal decongestants within 7 days prior to screening
- Any confirmed or suspected immunodeficient state
- Chronic respiratory diseases (except treatment -controlled asthma)
- Severe chronic cardiovascular and endocrinological diseases (e.g., medicine or insulin treated diabetes), liver and renal insufficiency or serious psychiatric diseases
- Any diagnosed disease or abnormality in the nasal or upper respiratory tract, such as acute/chronic rhinosinusitis; nasal polyposis; mucosal pathology or tumor of nasal cavity, pharynx or nasopharynx; significant obstructive nasal deformity; recurrent epistaxis; sleep apnea; anosmia
- Severe obesity (BMI ≥ 35)
- Cancer treated within 5 years
- Known allergy/hypersensitivity to any ingredients of the COV2 vaccine
- Previous anaphylactic reaction
- Any clinically significant abnormal finding in the screening laboratory tests
- Inability to sign ICF or to understand and comply with trial related instructions and requirements
- Individuals who are employees of, or directly affiliated with, the sponsor, or site staff or their immediate family members.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07416539