This is a Phase 1a, single-country, single-centre, single-blinded, COV2 vaccineformulation randomized trial designed to investigate and compare the safety andimmunogenicity of two COV2 vaccine formulations. COV2 is a nasal, investigational vaccineagainst COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2spike protein.Participants will receive one of the two COV2 formulations in two doses on Day 0 and Day28.This trial consists of two parts; Part 1 is a vaccination phase assessing safety andimmunogenicity and Part 2 is a long-term immunogenicity follow-up assessing persistenceof immune response.
Not Provided
Biological: COVID-19 Vaccines
COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each
dose.
Biological: COVID-19 Vaccines
COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each
dose.
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.
Kuopio University Hospital, ENT policlinic
Kuopio, Northern Savonia, Finland
Investigator: Laura Jääskeläinen, Registered Nurse
Contact: +358 40 7741104
laura.jaaskelainen@satucon.fi
Terhi Reunama
+358 40 510 5560
terhi.reunama@rokote.com
Erkko Ylösmäki
+358 40 5836604
erkko.ylosmaki@rokote.com
Seppo Ylä-Herttuala, Study Director
Rokote Laboratories Finland Oy