Official Title
An Open Short-term Clinical Pilot Trial on Safety and Immunogenicity of Nasal COVID-19 Vaccine At Different Dose Levels and Administration Methods
Brief Summary

COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5adenoviral vector producing the SARS-CoV-2 spike protein. In this trial, the primarycomparison in terms of safety and immunogenicity will be between two different doselevels of COV2 booster vaccine (low, high), and two different administration methods(nasal drops, nasal spray). In addition, COV2 vaccine will also be evaluated in vaccinenaive subjects.

Detailed Description

Not Provided

Recruiting
COVID19, Sars-Cov-2

Biological: COVID-19 vaccine, low dose level

Test article
Other Name: COV2

Biological: COVID-19 vaccine, high dose level

Test article
Other Name: COV2

Other: Nasal Drops

Method of administration of test article

Other: Nasal Spray

Method of administration of test article

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Finland
Locations

Kuopio University Hospital
Kuopio, Northern Savonia, Finland

Investigator: Laura Jääskeläinen, RN
Contact: +358 40 7741104
laura.jaaskelainen@satucon.fi

Contacts

Erkko Ylösmäki, PhD
+358 40 5836604
erkko.ylosmaki@rokote.com

Tobias Freitag, MD
tobias.freitag@rokote.com

Rokote Laboratories Finland Oy
NCT Number
Keywords
nasal vaccine
adeno-vectored vaccine
mucosal vaccine
SARS-CoV-2
COVID19
MeSH Terms
COVID-19
Vaccines