Respiratory Syncytial Virus InfectionsPhase 1EuRSVNCT06216093
Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years
A Phase 1 study testing EuRSV in people with Respiratory Syncytial Virus Infections and Respiratory Syncytial Virus (RSV), run by EuBiologics Co.,Ltd at 1 site in South Korea.
Trial summary
Phase 1 clinical trial to evaluate the safety of RSV-1 and RSV-2 vaccines in healthy adults aged 19 to 80 years who have voluntarily given written consent to participate in this study. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus (RSV)
- What is being tested?
- EuRSV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2024to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult men and women who meet the age criteria below
- Have a body mass index (BMI) of at least 18 Kg/m^2 and no more than 30 Kg/m^2 at the screening visit
- Women and men of childbearing potential who agree to use a highly effective method of contraception* for the duration of the study (up to 3 months after the last dose of study medication)
- Agree to refrain from donating blood and transfusions (whole blood, plasma components, platelet components, platelet-plasma components) for the duration of the study.
- After receiving and understanding a detailed explanation of this clinical trial, voluntarily decide to participate and give written consent.
- For women of childbearing potential, a negative pregnancy test prior to receiving the investigational drug.
Who cannot join
- Clinically significant abnormalities on clinical laboratory tests, electrocardiogram (ECG), or chest x-ray at screening.
- Positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test results at screening.
- Have had clinically significant symptoms of respiratory illness within 14 days prior to the first dose of investigational product (e.g., cough, sore throat, dyspnea, wheezing, or nocturnal awakenings due to respiratory symptoms).
- Active pulmonary infection within 14 days prior to the first dose of investigational medicinal product, or any other significant infectious disease that, in the opinion of the investigator, would render the subject ineligible for participation in the study.
- Have had an acute febrile illness of 38 celsius degrees or greater within 3 days prior to the first dose of investigational drug
- Have any of the following conditions, or any serious medical or neuropsychiatric condition that, in the opinion of the investigator, would make them ineligible to participate in this study
Show all 21Show fewer
- History of allergic reactions or hypersensitivity to any of the components of the investigational drug.
- History of serious adverse events, serious allergic reactions, or serious hypersensitivity reactions related to vaccination.
- History of platelet-related or hemorrhagic disease (such as major venous and/or arterial thrombosis with thrombocytopenia), or history of excessive bleeding or bruising after intramuscular injection or venipuncture, or receiving anticoagulant therapy (except that patients may participate if they are using low-dose anticoagulants (e.g., aspirin <100 mg/day) as determined by the investigator).
- History of systemic urticaria within 5 years prior to the first dose of investigational drug.
- Have a history of hereditary or idiopathic angioneurotic edema
- History of organ or bone marrow transplantation
- Suspected history of drug abuse or alcohol abuse within 6 months prior to the first dose of investigational medication.
- History of respiratory syncytial virus (RSV) vaccination or participation in an RSV vaccine clinical trial
- Treatment with immunosuppressive or immunomodulatory agents or chronic steroid use within 6 months prior to the first dose of investigational product.
- History of dependent use of antipsychotics or narcotic analgesics within 6 months prior to the first dose of study medication, or psychiatric or social conditions that, in the opinion of the investigator, would make it difficult to comply with the procedures of this study.
- Received any other investigational drug or received an investigational medical device within 6 months of the screening visit.
- Treatment with immunoglobulins or blood-derived products within 3 months prior to the first dose of investigational medicinal product or planned treatment during the study period
- Have received or plan to receive any other vaccine within 4 weeks prior to or after each dose of investigational product.
- Pregnant or lactating women
- For any other reason deemed by the investigator to be unsuitable as a patient in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Randomized, Observer-blind, Placebo-control, Parallel-group, first-in Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years
Phase 1 clinical trial to evaluate the safety of RSV-1 and RSV-2 vaccines in healthy adults aged 19 to 80 years who have voluntarily given written consent to participate in this study.
- Being tested
- EuRSV, Placebo Comparator
- Keywords
- EuRSV, RSV, Respiratory Syncytial Virus
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuRSVBiological
Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28.
Placebo ComparatorOther
Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28.
| Study group | Role | What they receive |
|---|---|---|
| RSV-1 | Experimental | Not described Receives: Biological: EuRSV |
| RSV-2 | Experimental | Not described Receives: Biological: EuRSV |
| Normal Saline | Placebo comparator | Not described Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited adverse events
local and systemic AEs
Measured: within 7 days post vaccination
Occurrence of immediate adverse events
local and systemic AEs
Measured: within 30 minutes post vaccination
Occurrence of unsolicited adverse events
local and systemic AEs
Measured: within 52 weeks post vaccination
Occurrence of serious adverse events
local and systemic AEs
Measured: within 52 weeks post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start8 May 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216093
- Sponsor's protocol ID
- EuRSV_101
- Acronym
- EuRSV
- Status last verified
- Jun 2025
- First submitted
- 2 Jan 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Observer-blind, Placebo-control, Parallel-group, first-in Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years
- ClinicalTrials.gov ID
- NCT06216093
- Acronym / sponsor ID
- EuRSV / EuRSV_101
- Keywords
- EuRSV, RSV, Respiratory Syncytial Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 clinical trial to evaluate the safety of RSV-1 and RSV-2 vaccines in healthy adults aged 19 to 80 years who have voluntarily given written consent to participate in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RSV-1 | Experimental | Biological: EuRSV |
| RSV-2 | Experimental | Biological: EuRSV |
| Normal Saline | Placebo comparator | Other: Placebo Comparator |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult men and women who meet the age criteria below
- Have a body mass index (BMI) of at least 18 Kg/m^2 and no more than 30 Kg/m^2 at the screening visit
- Women and men of childbearing potential who agree to use a highly effective method of contraception* for the duration of the study (up to 3 months after the last dose of study medication)
- Agree to refrain from donating blood and transfusions (whole blood, plasma components, platelet components, platelet-plasma components) for the duration of the study.
- After receiving and understanding a detailed explanation of this clinical trial, voluntarily decide to participate and give written consent.
Key exclusion criteria (21 listed)
- Clinically significant abnormalities on clinical laboratory tests, electrocardiogram (ECG), or chest x-ray at screening.
- Positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test results at screening.
- Have had clinically significant symptoms of respiratory illness within 14 days prior to the first dose of investigational product (e.g., cough, sore throat, dyspnea, wheezing, or nocturnal awakenings due to respiratory symptoms).
- Active pulmonary infection within 14 days prior to the first dose of investigational medicinal product, or any other significant infectious disease that, in the opinion of the investigator, would render the subject ineligible for participation in the study.
- Have had an acute febrile illness of 38 celsius degrees or greater within 3 days prior to the first dose of investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EuRSVHealthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28. | Biological | RSV-1, RSV-2 |
| Placebo ComparatorHealthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28. | Other | Normal Saline |
Primary outcome
Occurrence of solicited adverse events
Time frame: within 7 days post vaccination
local and systemic AEs
Occurrence of immediate adverse events
Time frame: within 30 minutes post vaccination
local and systemic AEs
Occurrence of unsolicited adverse events
Time frame: within 52 weeks post vaccination
local and systemic AEs
Occurrence of serious adverse events
Time frame: within 52 weeks post vaccination
local and systemic AEs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EuRSV in people with Respiratory Syncytial Virus Infections and Respiratory Syncytial Virus (RSV), run by EuBiologics Co.,Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited adverse events (time frame: within 7 days post vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.