The Safety and Antibody Response of the Nasal COV2 Vaccine Against the SARS-CoV-2 Virus

Last updated: February 24, 2025
Sponsor: Rokote Laboratories Finland Oy
Overall Status: Active - Recruiting

Phase

1

Condition

Covid-19

Treatment

Nasal Drops

Nasal Spray

COVID-19 vaccine, high dose level

Clinical Study ID

NCT06851611
COV2FIN11
U1111-1299-1228
2023-509725-49-00
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Nasal Drops
Phase: 1
Study Start date:
January 21, 2025
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Kuopio University Hospital

    Kuopio, Northern Savonia 70210
    Finland

    Active - Recruiting

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