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Active, not recruitingNCT06216093EuRSVUpdated Jun 15, 2025

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 interventional study of EuRSV and Placebo Comparator in Respiratory Syncytial Virus Infections and Respiratory Syncytial Virus (RSV), sponsored by EuBiologics Co.,Ltd. Active, not recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by EuBiologics Co.,Ltd · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Syncytial Virus Infections
  • Respiratory Syncytial Virus (RSV)

Keywords

  • EuRSV
  • RSV
  • Respiratory Syncytial Virus
03

In context

Respiratory Syncytial Virus Infections

306 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 50 are open to participants now.

This study's enrollment of 100 is above the median of 89 across 223 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

EuBiologics Co.,Ltd is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult men and women who meet the age criteria below
  2. Have a (BMI) of at least 18 Kg/m\^2 and no more than 30 Kg/m\^2 at the screening visit
  3. Women and men of who agree to use a highly effective method of * for the duration of the study (up to 3 months after the last dose of study medication)
  4. Agree to refrain from donating blood and transfusions (whole blood, plasma components, components, platelet-plasma components) for the duration of the study.
  5. After receiving and understanding a detailed explanation of this clinical trial, voluntarily decide to participate and give written consent.
  6. For women of childbearing potential, a negative pregnancy test prior to receiving the drug.

Exclusion criteria

Exclusion Criteria:

  1. abnormalities on clinical laboratory tests, (ECG), or chest x-ray at screening.
  2. Positive , , or (HIV) test results at screening.
  3. Have had clinically significant symptoms of respiratory illness within 14 days prior to the first dose of product (e.g., cough, sore throat, dyspnea, wheezing, or nocturnal awakenings due to respiratory symptoms).
  4. 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.
  5. Have had an acute febrile illness of 38 celsius degrees or greater within 3 days prior to the first dose of investigational drug
  6. 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
  7. History of allergic reactions or to any of the components of the investigational drug.
  8. History of serious adverse events, serious allergic reactions, or serious hypersensitivity reactions related to vaccination.
  9. History of -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).
  10. History of systemic urticaria within 5 years prior to the first dose of investigational drug.
  11. Have a history of hereditary or idiopathic angioneurotic edema
  12. History of organ or bone marrow transplantation
  13. Suspected history of drug abuse or alcohol abuse within 6 months prior to the first dose of investigational medication.
  14. History of respiratory syncytial virus (RSV) vaccination or participation in an RSV vaccine clinical trial
  15. Treatment with or immunomodulatory agents or chronic use within 6 months prior to the first dose of investigational product.
  16. 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.
  17. Received any other investigational drug or received an investigational medical device within 6 months of the screening visit.
  18. 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
  19. Have received or plan to receive any other vaccine within 4 weeks prior to or after each dose of investigational product.
  20. Pregnant or lactating women
  21. For any other reason deemed by the investigator to be unsuitable as a patient in this study
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    RSV-1

    Biological: EuRSV

  • Experimental
    RSV-2

    Biological: EuRSV

  • Placebo comparator
    Normal Saline

    Other: Placebo Comparator

Interventions

  • BiologicalEuRSV

    Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28.

  • OtherPlacebo Comparator

    Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28.

06

What researchers measure

Primary outcomes

  1. Occurrence of solicited adverse events

    local and systemic AEs

    Time frame: within 7 days post vaccination

  2. Occurrence of immediate adverse events

    local and systemic AEs

    Time frame: within 30 minutes post vaccination

  3. Occurrence of unsolicited adverse events

    local and systemic AEs

    Time frame: within 52 weeks post vaccination

  4. Occurrence of serious adverse events

    local and systemic AEs

    Time frame: within 52 weeks post vaccination

07

Study locations

1 site
  • Univsersity Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06216093
Lead sponsor
EuBiologics Co.,Ltd
Responsible party
Sponsor
First posted
Jan 22, 2024
Start date
May 8, 2024
Primary completion
Jul 31, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Jun 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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