Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19

Q: Who can participate in NCT07416539?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07416539?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

A Phase 1a, Single-Blind, Randomized Comparative Clinical Trial Evaluating the Impact of Vaccine Formulation on the Safety and Immunogenicity of the COV2 Vaccine in Healthy Adults

Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19 (NCT07416539) is a Phase 1 interventional studying COVID - 19 and SARS CoV-2, sponsored by Rokote Laboratories Finland Oy. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This is a Phase 1a, single-country, single-centre, single-blinded, COV2 vaccine formulation randomized trial designed to investigate and compare the safety and immunogenicity of two COV2 vaccine formulations. COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2 spike protein. Participants will receive one of the two COV2 formulations in two doses on Day 0 and Day 28. This trial consists of two parts; Part 1 is a vaccination phase assessing safety and immunogenicity and Part 2 is a long-term immunogenicity follow-up assessing persistence of immune response.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For COVID - 19, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion criteria - Has voluntarily signed the written willing to sign a consent form - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Kuopio University Hospital, ENT policlinic

Kuopio, Northern Savonia, Finland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07416539), the sponsor (Rokote Laboratories Finland Oy), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07416539 clinical trial studying?

Who can participate in NCT07416539?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07416539?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07416539. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07416539. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.