Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine （CHO Cell） in Adults Aged 18 Years and Older

NCT07807449 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: V001-RSV-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study in China will evaluate the Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged 18 Years and Older

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

RSV vaccine; Acute Respiratory Infection; Lower Respiratory Track Disease

Outcome Measures

Primary Outcomes (3)

• Incidence of immediate adverse events

  Incidence of all adverse events within 30 minutes after vaccination

  Within 30 minutes after vaccination

• Incidence of solicited AEs

  Incidence of solicited (local and systemic) adverse events within 14 days after vaccination

  Within 0-14 days after vaccination

• Incidence of unsolicited AEs

  Incidence of unsolicited adverse events within 30 days after vaccination

  Within 30 days after vaccination

Secondary Outcomes (18)

• Incidence of clinically significant abnormalities in clinical laboratory tests

  4 days after vaccination

• Incidence of clinically significant abnormal findings on 12-lead electrocardiograms

  4 days, 14 days, 30 days after vaccination

• Occurrence of serious adverse events (SAEs)

  Within 24 months after vaccination

• Occurrence of adverse events of special interest (AESIs)

  Within 12 months after vaccination

• GMT of Neutralizing Antibody against RSV serotype A and B

  30 days after vaccination

Study Arms (10)

Low-Dose Antigen Cohort in subjects aged 18-59 years

EXPERIMENTAL

Subjects aged 18-59 years will receive single dose of Recombinant RSV Vaccine (CHO Cell), by IM injection into the deltoid muscle of the upper arm.

Biological: Recombinant RSV Vaccine (CHO Cell)

High-Dose Antigen Cohort in subjects aged 18-59 years

EXPERIMENTAL

Subjects aged 18-59 years will receive double dose of Recombinant RSV Vaccine (CHO Cell), by IM injection into the deltoid muscle of the upper arm.

Biological: Recombinant RSV Vaccine (CHO Cell)

Adjuvant Cohort in subjects aged 18-59 years

EXPERIMENTAL

Subjects aged 18-59 years will receive single dose of Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm.

Biological: Adjuvant Suspension

Low-Dose Antigen + Adjuvant Cohort in subjects aged 18-59 years

EXPERIMENTAL

Subjects aged 18-59 years will receive single dose of Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm.

Biological: Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension

Placebo group in subjects aged 18-59 years

PLACEBO COMPARATOR

Subjects aged 18-59 years will receive single dose of placebo, by IM injection into the deltoid muscle of the upper arm.

Biological: Saline solution

Low-Dose Antigen Cohort in subjects aged ≥60 years

EXPERIMENTAL

Subjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine(CHO Cell), by IM injection into the deltoid muscle of the upper arm.

Biological: Recombinant RSV Vaccine (CHO Cell)

High-Dose Antigen Cohort in subjects aged ≥60 years

EXPERIMENTAL

Subjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine(CHO Cell), by IM injection into the deltoid muscle of the upper arm.

Biological: Recombinant RSV Vaccine (CHO Cell)

Adjuvant Cohort in subjects aged ≥60 years

EXPERIMENTAL

Subjects aged ≥60 years will receive single dose of Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm.

Biological: Adjuvant Suspension

Low-Dose Antigen + Adjuvant Cohort in subjects aged ≥60 years

EXPERIMENTAL

Subjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm.

Biological: Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension

Placebo group in subjects aged ≥60 years

PLACEBO COMPARATOR

Subjects aged ≥60 years will receive single dose of placebo, by IM injection into the deltoid muscle of the upper arm.

Biological: Saline solution

Interventions

Recombinant RSV Vaccine (CHO Cell) BIOLOGICAL

0.4 mL per dose

Low-Dose Antigen Cohort in subjects aged 18-59 years; Low-Dose Antigen Cohort in subjects aged ≥60 years

Adjuvant Suspension BIOLOGICAL

0.9 mL per dose

Adjuvant Cohort in subjects aged 18-59 years; Adjuvant Cohort in subjects aged ≥60 years

Saline solution BIOLOGICAL

0.9 mL per dose

Placebo group in subjects aged 18-59 years; Placebo group in subjects aged ≥60 years

Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension BIOLOGICAL

0.9 mL per dose

Low-Dose Antigen + Adjuvant Cohort in subjects aged 18-59 years; Low-Dose Antigen + Adjuvant Cohort in subjects aged ≥60 years

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and older who reside in the local area and can provide legal proof of identity; sex is not restricted;
• Trial participants understand the informed consent form and the vaccine to be administered, voluntarily agree to participate and sign the informed consent form, and are able to use a thermometer and ruler and complete the diary card and contact card as required. If a participant is unable to sign the informed consent form independently because of limited literacy, the informed consent process and signature may be completed with the assistance of an impartial witness;
• Able to communicate effectively with the investigator and understand and comply with all trial requirements;
• Women of childbearing potential (see Appendix 2 for the definition) must have used effective contraception for 2 weeks before enrollment, have a negative urine pregnancy test before investigational vaccine administration (women not of childbearing potential are exempt), and voluntarily agree to continue using at least one effective contraceptive method for 6 months after vaccination. Effective contraception includes oral contraceptives, injectable or implantable contraception, long-acting local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, male condoms, diaphragms, cervical caps, etc. Male trial participants must agree to use effective contraception with female partners of reproductive potential from the screening visit until 6 months after immunization.

You may not qualify if:

• Abnormal pre-vaccination laboratory tests (complete blood count, blood biochemistry, coagulation function, C-reactive protein, or urinalysis) or 12-lead electrocardiogram findings that, based on medical history and clinical presentation, render the person unsuitable for vaccination in the investigator's judgment;
• Abnormal skin at the vaccination sites on both arms at the vaccination visit (e.g., inflammation, induration, erythema/swelling, or extensive scars);
• Hypertension not controlled by medication, or pre-enrollment systolic blood pressure of at least 160 mmHg and/or diastolic blood pressure of at least 100 mmHg;
• Axillary temperature of at least 37.1 degrees C on the day of vaccination; fever, acute illness, or an acute exacerbation of chronic disease within the preceding 3 days; or use of antipyretic/analgesic or anti-allergy medications within the preceding 3 days;
• Communicable period of any infectious disease, acute infection, or acute phase of chronic infection (e.g., active untreated tuberculosis) (by interview);
• Laboratory-confirmed RSV infection within the previous 12 months, or previous receipt of, or planned receipt of, any marketed or investigational RSV vaccine or RSV monoclonal antibody;
• Documented history of atrial fibrillation;
• History of severe allergic reactions requiring medical intervention \[e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrotic reaction (Arthus reaction)\]; history of allergy to any component of the investigational vaccine; or history of other severe adverse reactions to vaccination;
• Physician-diagnosed abnormal coagulation function (e.g., coagulation factor deficiency, coagulation disease, or platelet abnormalities) or coagulation disorder that may contraindicate intramuscular injection;
• Anatomic or functional asplenia, or asplenia/splenectomy resulting from any condition;
• Current diagnosed neurologic or psychiatric disorder (including dementia, schizophrenia, or bipolar disorder), previous diagnosis of epilepsy or seizures (excluding febrile seizures in childhood), or other neurologic disease considered unsuitable for trial participation by the investigator;
• Diagnosed congenital or acquired immunodeficiency disease, such as human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, or another immune disease that may affect the trial assessment in the investigator's judgment;
• Long-term use (continuous use for 2 weeks or more) of immunosuppressants or other immunomodulatory medication within 6 months before enrollment or planned within 30 days after vaccination, such as long-term systemic corticosteroid therapy (continuous use for 2 weeks or more at a dose of at least 2 mg/kg/day or at least 20 mg/day of prednisone or equivalent). Topical medication (e.g., ointments, eye drops, inhalants, or nasal sprays) is permitted provided the labeled recommended dose is not exceeded;
• Known serious congenital malformation; developmental disorder or clinically diagnosed serious chronic disease (e.g., Down syndrome, diabetes with complications, sickle cell anemia, or neurologic disease);
• History of immune-mediated demyelinating disease, including but not limited to multiple sclerosis, neuromyelitis optica, acute disseminated encephalomyelitis, transverse myelitis, or Guillain-Barre syndrome;

Sponsors & Collaborators

• Yikang Biotech (Suzhou) Co., Ltd.: lead
• Jiangsu Province Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Yixing People's Hospital

Yixing, Jiangsu, 214200, China

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Xuqin Yang, Master

CONTACT

+86-18600534482; yangxuqin@ykangbio.com

Study Design

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

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): January 22, 2027
• Study Completion (Estimated): January 22, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)