Actively Recruiting
A Phase 1a, Single-Blind, Randomized Trial Comparing Safety and Immune Response of Two COV2 Vaccine Formulations in Healthy Adults
Led by Rokote Laboratories Finland Oy · Updated on 2026-02-20
20
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating two formulations of an investigational nasal vaccine called COV2, designed to protect against COVID-19. This Phase 1a, single-blind, randomized trial aims to compare the safety and immune response produced by these two vaccine formulations in healthy adults aged 18 to 75 years. The vaccine uses a modified adenoviral vector to deliver the SARS-CoV-2 spike protein to stimulate immunity. Participants will receive two doses of either formulation A or formulation B of the COV2 vaccine, administered as a nasal spray on Day 0 and Day 28. The study is divided into two parts: an initial vaccination phase to assess safety and immune response, followed by a long-term follow-up to monitor how well the immune response persists over time. During the trial, participants will be monitored for safety from Day 0 to Day 56 and evaluated for immune response at Day 56 compared to baseline. They will use a personal device with internet access to report data and comply with study instructions. The total participation includes screening, vaccination, and extended follow-up to understand the vaccine's impact on immune protection against COVID-19.
CONDITIONS
Brief 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...
- Has voluntarily signed the written informed consent
- Male or female aged 6518 to 6575 years
- Good general health based on medical history, lab tests, physical and ENT examinations, and vital signs
- Prior vaccination with 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 study instructions
- Not of childbearing potential or willing to use effective contraception throughout the trial
You will not qualify if you...
- Pregnant, planning to become pregnant, or breastfeeding women
- Received any investigational drug within 180 days before baseline
- Confirmed or suspected COVID-19 infection less than 180 days before or during screening/baseline
- Any SARS-CoV vaccination within 180 days before Day 0
- Any other vaccination within 60 days before Day 0
- Immunoglobulin or blood product administration within 90 days before baseline
- Current use of immunosuppressant drugs (except certain 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 immunodeficient condition
- Chronic respiratory diseases (except controlled asthma)
- Severe chronic cardiovascular, endocrine diseases, liver or kidney failure, or serious psychiatric illness
- Diagnosed nasal or upper respiratory tract diseases like rhinosinusitis, nasal polyps, tumors, obstructive deformities, recurrent nosebleeds, sleep apnea, or loss of smell
- Severe obesity (BMI 35 or higher)
- Cancer treated within 5 years
- Known allergy or hypersensitivity to vaccine ingredients
- Previous anaphylactic reaction
- Significant abnormal lab findings at screening
- Unable to consent or comply with study requirements
- Employees or immediate family of sponsor or site staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 56 days
Participants receive two doses of the COV2 vaccine formulation as a nasal spray, with 28 days between each dose.
2 dosing visits (in-person) over 28 days
Trial Site Locations
Total: 1 location
1
Kuopio University Hospital, ENT policlinic
Kuopio, Northern Savonia, Finland, 70210
Actively Recruiting
Research Team
T
Terhi Reunama
E
Erkko Ylösmäki
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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