An Open Short-term Clinical Pilot Trial on Safety and Immunogenicity of Nasal COVID-19 Vaccine at Different Dose Levels and Administration Methods
Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing the SARS-CoV-2 spike protein. In this trial, the primary comparison in terms of safety and immunogenicity will be between two different dose levels of COV2 booster vaccine (low, high), and two different administration methods (nasal drops, nasal spray). In addition, COV2 vaccine will also be evaluated in vaccine naive subjects.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
• Has voluntarily signed the written informed consent
• 18-75 years old
• Good general health
• a) Prior vaccination with at least two doses of any COVID-19 vaccine, OR b) No prior COVID-19 vaccination
Locations
Other Locations
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Contact Information
Primary
Erkko Ylösmäki, PhD
erkko.ylosmaki@rokote.com
+358 40 5836604
Backup
Tobias Freitag, MD
tobias.freitag@rokote.com
Time Frame
Start Date: 2025-01-21
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 50
Treatments
Experimental: Booster - COV2 Low Dose Level - Nasal Drops
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
Experimental: Booster - COV2 Low Dose Level - Nasal Spray
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
Experimental: Booster - COV2 High Dose Level - Nasal Drops
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
Experimental: Booster - COV2 High Dose Level - Nasal Spray
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
Experimental: Prime - COV2 High Dose Level - Nasal Drops
Subjects with no prior COVID-19 vaccination
Experimental: Prime - COV2 High Dose Level - Nasal Spray
Subjects with no prior COVID-19 vaccination
Related Therapeutic Areas
Sponsors
Leads: Rokote Laboratories Finland Oy