COV2 nasal vaccine formulations to boost antibodies against the 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
This trial will test two nasal COV2 vaccine formulations in adults who previously completed primary COVID-19 vaccination to see which one best triggers antibody responses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Rokote Laboratories Finland Oy Industry-sponsored |
| Locations | 1 site (Kuopio, Northern Savonia) |
| Trial ID | NCT07416539 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1a, single-centre, single-blinded, randomized trial comparing two formulations of an investigational intranasal COV2 vaccine based on an adenoviral vector expressing a modified SARS‑CoV‑2 spike protein. Participants receive two doses, on Day 0 and Day 28, with Part 1 focused on short-term safety and immune responses and Part 2 following participants for long-term persistence of immunity. Eligible adults (18–75) must have completed at least two prior COVID-19 vaccine doses with the last dose at least 180 days before enrollment. Safety monitoring includes clinical exams, ENT assessment, and laboratory tests, while immunogenicity is measured by antibody responses over time.
Who should consider this trial
Good fit: Adults aged 18–75 in good general health who received at least two doses of any COVID-19 vaccine with the last dose at least 180 days earlier and who can use a smartphone or computer to report study data are ideal candidates.
Not a fit: People who are pregnant, breastfeeding, recently received investigational drugs or recent COVID-19 vaccination, or who have an active SARS‑CoV‑2 infection are unlikely to be eligible or receive benefit from this trial.
Why it matters
Potential benefit: If successful, a safe and effective nasal formulation could raise mucosal and systemic antibodies and potentially help prevent infection or reduce transmission.
How similar studies have performed: Nasal adenoviral-vector vaccines are an emerging approach with encouraging preclinical and some early-phase human data for mucosal immunity, but clinical evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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 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 * Current use of immunosuppressant medication (except topical and inhaled steroids, which are permitted in indications not prohibited in the exclusion criteria) * 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 \- Medication for elevated cholesterol or blood pressure or dietary treated diabetes or hypothyreosis are not exclusion criteria * 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 \- History of adenoidectomy and/or tonsillectomy are not exclusion criteria * 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.
Where this trial is running
Kuopio, Northern Savonia
- Kuopio University Hospital, ENT policlinic — Kuopio, Northern Savonia, Finland (Recruiting)
Study contacts
- Study coordinator: Terhi Reunama
- Email: terhi.reunama@rokote.com
- Phone: +358 40 510 5560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.