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Active, not recruiting Phase 1/2

Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

NCT06642558 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2024-11-13
Last updated
2025-06-06

Condition(s) studied

Respiratory Syncytial Virus (RSV)

Investigational drug(s) / intervention(s)

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)Placebo (Saline solution)

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose): 0.25 mL per dose.

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose): 0.5 mL per dose

Placebo (Saline solution): 0.5 mL per dose

Study summary

The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccine(CHO cells), when administered intramuscularly (IM) in healthy adults aged 18 years and older.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. A male or female, in the opinion of the investigator, aged 18 and older for phase 1 and aged 50 and older for phase 2 at the time of the enrollment; 2. Be able to understand the trial procedures, risks and benefits and voluntarily agree to participate in the study and signed an informed consent; 3. Be able to participate in all scheduled visits and comply with the protocol requirements; 4. Women of childbearing potential are willing to use effective contraception (e.g. oral contraceptives, injectable progestogen, implants of levonorgestrel, percutaneous contraceptive patches, intrauterine device (IUD), female and male sterilization, abstinence, condoms, or diaphragms), and the rhythm method, withdrawal and emergency contraception pills are not acceptable; 5. Subjects with stable conditions considered by the investigator. Exclusion Criteria: 1. Axillary temperature\>37.0℃; 2. History of RSV infection within 6 months before enrollment; 3. New onset of respiratory tract infection symptoms like cough, sputum, shortness of breath, wheezing, fever, runny nose or nasal congestion within 7 days before enrollment; 4. Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination; 5. A known allergy to any components of the study vaccine, or history of severe allergy (e.g. anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, severe urticaria) or serious adverse reactions to any previous vaccination or drug use; 6. Pregnant (urine pregnancy test was positive) or lactating female, or planned pregnancy within 12 months after vaccination; 7. Any confirmed or suspected immunosuppressive or immunodeficient condition due to diseases or immunosuppressive therapy, based on medical history and physical examination; 8. Serious or unstable chronic illness, including but not limit to cardiovascular diseases (such as uncontrolled hypertension, coronary heart disease, myocarditis, pericarditis), metabolic diseases (such as poorly controlled diabetes), hematological diseases (such as severe anemia, hemophilia), liver and kidney diseases, digestive diseases, respiratory diseases (such as chronic obstructive pulmonary disease, active tuberculosis, other severe respiratory diseases ), malignant tumor, major functional organ transplantation history; 9. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study; 10. History of thrombocytopenia or other coagulation disorders; 11. History of convulsions, epilepsy, congenital brain dysplasia, mental illness or family history, or history of brain nerve tissue damage due to other severe neurological disorders(e.g. brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, chemical drug poisoning); 12. History of cognitive dysfunction, or any moderate or severe cognitive impairment; 13. Asplenia or functional asplenia, or autoimmune thyroid diseases, such as Hashimoto thyroiditis, toxic diffuse goiter; 14. Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination; 15. Previous vaccination with an RSV vaccine; 16. Administration of long-acting immune-modifying drugs(e.g. Infliximab) or planned administration at any time during the study period; 17. Administration of immunoglobulins and/or any blood products during the period starting 3 months before vaccination or planned administration during the study period; 18. Chronic administration of immunosuppressants or other immune-modifying drugs (such as long-term use of systemic glucocorticoid ≥14 days, ≥20mg/day prednisone or equivalent dose) during the period starting 3 months before vaccination or planned administration during the study period, but topical steroids(e.g. ointment, eye drops, inhalants, nasal sprays) that do not exceed the dosage recommended in the instructions or have any systemic signs are acceptable; 19. History of alcohol or drug abuse; 20. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product; 21. Planned move to a location that will prohibit participating in the trial until study end; 22. At screening: Any laboratory test results(hematology, clinical chemistry, coagulation function, or urinalysis) abnormal and clinically significant in the judgment of the investigator (Only for phase 1); 23. At screening: Any electrocardiogram abnormal and clinically significant in the judgment of the investigator (Only for phase 1); 24. Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.

Primary outcome measure(s)

  • Incidence, Intensity and Causality of adverse events(AE) — Within 30 days after vaccination
    An AE includes any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not related to the investigational product.
  • Incidence, Intensity and Causality of solicited AEs — Within 14 days after vaccination
    Solicited AEs include solicited local and general symptoms; Assessed solicited local AEs at injection site are pain, erythema, swelling, induration and itching; Assessed solicited general symptoms include fever, fatigue, headache, myalgia, nausea, vomiting, diarrhea, arthralgia and hypersensitivity.
  • Incidence, Intensity and Causality of unsolicited AEs — Within 30 days after vaccination
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
  • Incidence, Intensity and Causality of Severe adverse events(SAEs) — Within 30 days after vaccination
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability/incapacity or are congenital anomaly/birth defect.
  • Incidence, Intensity and Causality of Adverse events of special interest(AESI) — Within 30 days after vaccination
    Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.
  • Incidence of abnormal and clinically significant laboratory test results - only for phase 1 — The 3rd day after vaccination
    Laboratory test includes hematology, blood biochemistry, coagulation test, urine analysis and Electrocardiograph.
  • Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A — 30 days after vaccination
    Measured by Virus Neutralization Test.
  • GMT of Neutralizing Antibody against RSV-serotype B — 30 days after vaccination
    Measured by Virus Neutralization Test.
  • Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A — 30 days after vaccination
    Compared with the baseline Titer(Day 0).
  • GMFR of Neutralizing Antibody against RSV-serotype B — 30 days after vaccination
    Compared with the baseline Titer(Day 0).
  • Geometric Mean Concentration (GMC) of RSV-Prefusion F protein(RSV-PreF) specific Immunoglobulin G (IgG) Antibody against RSV-serotype A — 30 days after vaccination
    Measured by ELISA.
  • GMC of RSV-PreF specific IgG Antibody against RSV-serotype B — 30 days after vaccination
    Measured by ELISA.
  • GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A — 30 days after vaccination
    Compared with the baseline concentration(Day 0).
  • GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B — 30 days after vaccination
    Compared with the baseline concentration(Day 0).

Trial sites (1)

FacilityCityRegionStatus
Liangyuan District Center for Disease Prevention and Control Shangqiu Henan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06642558 on ClinicalTrials.gov ↗ ← All trials in China