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

NCT06642558 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MKKCT-900-001
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (14)

• Incidence, Intensity and Causality of adverse events(AE)

  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.

  Within 30 days after vaccination

• Incidence, Intensity and Causality of solicited AEs

  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.

  Within 14 days after vaccination

• Incidence, Intensity and Causality of unsolicited AEs

  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.

  Within 30 days after vaccination

• Incidence, Intensity and Causality of Severe adverse events(SAEs)

  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.

  Within 30 days after vaccination

• Incidence, Intensity and Causality of Adverse events of special interest(AESI)

  Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.

  Within 30 days after vaccination

• Incidence of abnormal and clinically significant laboratory test results - only for phase 1

  Laboratory test includes hematology, blood biochemistry, coagulation test, urine analysis and Electrocardiograph.

  The 3rd day after vaccination

• Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A

  Measured by Virus Neutralization Test.

  30 days after vaccination

• GMT of Neutralizing Antibody against RSV-serotype B

  Measured by Virus Neutralization Test.

  30 days after vaccination

• Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A

  Compared with the baseline Titer(Day 0).

  30 days after vaccination

• GMFR of Neutralizing Antibody against RSV-serotype B

  Compared with the baseline Titer(Day 0).

  30 days after vaccination

• Geometric Mean Concentration (GMC) of RSV-Prefusion F protein(RSV-PreF) specific Immunoglobulin G (IgG) Antibody against RSV-serotype A

  Measured by ELISA.

  30 days after vaccination

• GMC of RSV-PreF specific IgG Antibody against RSV-serotype B

  Measured by ELISA.

  30 days after vaccination

• GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A

  Compared with the baseline concentration(Day 0).

  30 days after vaccination

• GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B

  Compared with the baseline concentration(Day 0).

  30 days after vaccination

Secondary Outcomes (11)

• Incidence, Intensity and Causality of SAEs

  Up to 12 months post vaccination

• Incidence, Intensity and Causality of AESI

  Up to 12 months post vaccination

• GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B

  14 days post vaccination-only for phase 1

• GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B

  14 days post vaccination-only for phase 1

• GMC of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B

  14 days post vaccination-only for phase 1

Study Arms (12)

Low dose vaccine group in subjects aged 18-59 years - Phase 1

EXPERIMENTAL

Subjects aged 18-59 years in phase 1 will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose), by IM injection into the deltoid region of the arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)

High dose vaccine group in subjects aged 18-59 years - Phase 1

EXPERIMENTAL

Subjects aged 18-59 years in phase 1 will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose), by IM injection into the deltoid region of the arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)

Placebo group in subjects aged 18-59 years - Phase 1

PLACEBO COMPARATOR

Subjects aged 18-59 years in phase 1 will receive single dose of placebo, by IM injection into the deltoid region of the arm.

Biological: Placebo (Saline solution)

Low dose vaccine group in subjects aged ≥60 years - Phase 1

EXPERIMENTAL

Subjects aged ≥60 years in phase 1 will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose), by IM injection into the deltoid region of the arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)

High dose vaccine group in subjects aged ≥60 years - Phase 1

EXPERIMENTAL

Subjects aged ≥60 years in phase 1 will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose), by IM injection into the deltoid region of the arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)

Placebo group in subjects aged ≥60 years - Phase 1

PLACEBO COMPARATOR

Subjects aged ≥60 years in phase 1 will receive single dose of placebo, by IM injection into the deltoid region of the arm.

Biological: Placebo (Saline solution)

Low dose vaccine group in subjects aged 50-59 years - Phase 2

EXPERIMENTAL

Subjects aged 50-59 years in phase 2 will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose), by IM injection into the deltoid region of the arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)

High dose vaccine group in subjects aged 50-59 years - Phase 2

EXPERIMENTAL

Subjects aged 50-59 years in phase 2 will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose), by IM injection into the deltoid region of the arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)

Placebo group in subjects aged 50-59 years - Phase 2

PLACEBO COMPARATOR

Subjects aged 50-59 years in phase 2 will receive single dose of placebo, by IM injection into the deltoid region of the arm.

Biological: Placebo (Saline solution)

Low dose vaccine group in subjects aged ≥60 years - Phase 2

EXPERIMENTAL

Subjects aged ≥60 years in phase 2 will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose), by IM injection into the deltoid region of the arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)

High dose vaccine group in subjects aged ≥60 years - Phase 2

EXPERIMENTAL

Subjects aged ≥60 years in phase 2 will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose), by IM injection into the deltoid region of the arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)

Placebo group in subjects aged ≥60 years - Phase 2

PLACEBO COMPARATOR

Subjects aged ≥60 years in phase 2 will receive single dose of placebo, by IM injection into the deltoid region of the arm.

Biological: Placebo (Saline solution)

Interventions

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose) BIOLOGICAL

0.25 mL per dose.

Low dose vaccine group in subjects aged 18-59 years - Phase 1; Low dose vaccine group in subjects aged 50-59 years - Phase 2; Low dose vaccine group in subjects aged ≥60 years - Phase 1; Low dose vaccine group in subjects aged ≥60 years - Phase 2

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose) BIOLOGICAL

0.5 mL per dose

High dose vaccine group in subjects aged 18-59 years - Phase 1; High dose vaccine group in subjects aged 50-59 years - Phase 2; High dose vaccine group in subjects aged ≥60 years - Phase 1; High dose vaccine group in subjects aged ≥60 years - Phase 2

Placebo (Saline solution) BIOLOGICAL

0.5 mL per dose

Placebo group in subjects aged 18-59 years - Phase 1; Placebo group in subjects aged 50-59 years - Phase 2; Placebo group in subjects aged ≥60 years - Phase 1; Placebo group in subjects aged ≥60 years - Phase 2

Eligibility Criteria

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

You may qualify if:

• 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;
• Be able to understand the trial procedures, risks and benefits and voluntarily agree to participate in the study and signed an informed consent;
• Be able to participate in all scheduled visits and comply with the protocol requirements;
• 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;
• Subjects with stable conditions considered by the investigator.

You may not qualify if:

• Axillary temperature\>37.0℃;
• History of RSV infection within 6 months before enrollment;
• 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;
• Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
• 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;
• Pregnant (urine pregnancy test was positive) or lactating female, or planned pregnancy within 12 months after vaccination;
• Any confirmed or suspected immunosuppressive or immunodeficient condition due to diseases or immunosuppressive therapy, based on medical history and physical examination;
• 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;
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study;
• History of thrombocytopenia or other coagulation disorders;
• 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);
• History of cognitive dysfunction, or any moderate or severe cognitive impairment;
• Asplenia or functional asplenia, or autoimmune thyroid diseases, such as Hashimoto thyroiditis, toxic diffuse goiter;
• Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
• Previous vaccination with an RSV vaccine;

Sponsors & Collaborators

• MAXVAX Biotechnology Limited Liability Company: lead
• Henan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Liangyuan District Center for Disease Prevention and Control

Shangqiu, Henan, 476000, China

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Lili Huang

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

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: October 11, 2024
• First Posted: October 15, 2024
• Study Start: November 13, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)