Nasal vaccine for COVID-19
An Open Short-term Clinical Pilot Trial on Safety and Immunogenicity of Nasal COVID-19 Vaccine at Different Dose Levels and Administration Methods
This study tests a new nasal vaccine for COVID-19 to see how safe it is and how well it works in people who have or haven't been vaccinated before.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Rokote Laboratories Finland Oy Industry-sponsored |
| Locations | 1 site (Kuopio, Northern Savonia) |
| Trial ID | NCT06851611 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and immune response of a nasal vaccine, COV2, designed to protect against COVID-19. It compares two different dose levels of the vaccine and two administration methods: nasal drops and nasal spray. The study includes participants who have either received prior COVID-19 vaccinations or are vaccine naive, aiming to assess the vaccine's effectiveness in both groups.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-75 who have either received at least two doses of any COVID-19 vaccine or have not been vaccinated against COVID-19.
Not a fit: Patients who are pregnant, breastfeeding, or have had a COVID-19 infection in the last nine months may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a new, effective method for preventing COVID-19 through a non-invasive nasal administration.
How similar studies have performed: Other studies on nasal vaccines for COVID-19 have shown promise, but this specific approach is still being evaluated for its safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Has voluntarily signed the written informed consent 2. 18-75 years old 3. Good general health 4. a) Prior vaccination with at least two doses of any COVID-19 vaccine, OR b) No prior COVID-19 vaccination Exclusion Criteria 1. Pregnant, planning to become pregnant or breastfeeding women 2. COVID-19 infection within the last nine (9) months 3. Any other vaccination within the last two (2) months
Where this trial is running
Kuopio, Northern Savonia
- Kuopio University Hospital — Kuopio, Northern Savonia, Finland (Recruiting)
Study contacts
- Study coordinator: Erkko Ylösmäki, PhD
- Email: erkko.ylosmaki@rokote.com
- Phone: +358 40 5836604
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.