Actively Recruiting
Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19
Led by Rokote Laboratories Finland Oy · Updated on 2026-02-20
20
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
Sponsors
R
Rokote Laboratories Finland Oy
Lead Sponsor
O
Oy Medfiles Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed written informed consent
- Male or female aged 18 to 75 years
- Good general health based on medical history, lab tests, physical and ENT examinations, and vital signs
- Received at least two doses of any COVID-19 vaccine with last dose at least 180 days before Day 0
- Has a personal smartphone, tablet, or computer with internet access and can report data electronically
- Willing and able to follow participant instructions
- Not of childbearing potential or willing to use highly effective contraception throughout the trial
You will not qualify if you...
- Pregnant, planning pregnancy, or breastfeeding
- Received any investigational drug within 180 days before baseline
- Positive antigen or PCR test for SARS-CoV-2 infection within 180 days before or during screening/baseline
- Received any SARS-CoV vaccine within 180 days before Day 0
- Any other vaccination within 60 days before Day 0
- Received immunoglobulins or blood products within 90 days before baseline
- Current use of immunosuppressants (except allowed topical/inhaled steroids)
- Use of steroid nasal sprays within 30 days before screening
- Use of oral or nasal decongestants within 7 days before screening
- Any confirmed or suspected immunodeficiency
- Chronic respiratory diseases except controlled asthma
- Severe chronic cardiovascular, endocrinological diseases, liver or kidney failure, or serious psychiatric diseases
- Diagnosed nasal or upper respiratory tract diseases such as rhinosinusitis, nasal polyposis, tumors, obstructive nasal deformities, recurrent nosebleeds, sleep apnea, or loss of smell
- Severe obesity with BMI 35 or higher
- Cancer treated within past 5 years
- Known allergy or hypersensitivity to any COV2 vaccine ingredients
- Previous anaphylactic reaction
- Clinically significant abnormal lab findings at screening
- Unable to sign informed consent or comply with trial requirements
- Employees or immediate family of sponsor or site staff
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kuopio University Hospital, ENT policlinic
Kuopio, Northern Savonia, Finland, 70210
Actively Recruiting
Research Team
T
Terhi Reunama
CONTACT
E
Erkko Ylösmäki
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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