Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years

NCT06216093 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: EuRSV_101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus (RSV)

Keywords

EuRSV; RSV; Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (4)

• Occurrence of solicited adverse events

  local and systemic AEs

  within 7 days post vaccination

• Occurrence of immediate adverse events

  local and systemic AEs

  within 30 minutes post vaccination

• Occurrence of unsolicited adverse events

  local and systemic AEs

  within 52 weeks post vaccination

• Occurrence of serious adverse events

  local and systemic AEs

  within 52 weeks post vaccination

Study Arms (3)

RSV-1

EXPERIMENTAL

Biological: EuRSV

RSV-2

EXPERIMENTAL

Biological: EuRSV

Normal Saline

PLACEBO COMPARATOR

Other: Placebo Comparator

Interventions

EuRSV BIOLOGICAL

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

RSV-1; RSV-2

Placebo Comparator OTHER

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

Normal Saline

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• EuBiologics Co.,Ltd: lead

Study Sites (1)

Univsersity Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 22, 2024
• Study Start: May 8, 2024
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

KR (1)