A Study to Evaluate the Immune Response Features Following Vaccination With a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)

NCT07618325 | Not Yet Recruiting

• 1 other identifier: MKKCT-900-005
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to elucidate the molecular mechanism by which novel adjuvants enhance the immunogenicity of Respiratory Syncytial Virus (RSV) vaccines by regulating antigen-specific B cell affinity maturation and T cell memory formation.

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (3)

• Neutralizing Antibodies against both the RSV-A and RSV-B subtypes.

  Measured by Virus Neutralization Test.

  At pre-vaccination (Day 1), and at 1, 12, and 24 months post-vaccination.

• Specific IgG Antibodies to RSV pre-F of both RSV-A and RSV-B subtypes.

  Measured by ELISA.

  At pre-vaccination (Day 1), and at 1 month, 12 months, and 24 months post-vaccination.

• The Frequency of RSV pre-F Specific Cluster of Differentiation 4+ (CD4+) T Cells or Cluster of Differentiation 8+ (CD8+) T cells Expressing.

  Among markers expressed were interleukin-2 (IL-2), cluster of 40 ligand (CD40L), tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSV-PreF peptide preparations. Measured by Intracellular Cytokine Staining (ICS).

  At pre-vaccination (Day 1), and at 1 month, 12 months, and 24 months post-vaccination.

Study Arms (1)

Vaccine Group

EXPERIMENTAL

Participants will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell), by IM injection into the deltoid muscle of the upper arm.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)

Interventions

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) BIOLOGICAL

0.5 mL per dose

Vaccine Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 20 years of age or older as determined by the investigator at enrollment.
• Participants must be able to understand study procedures, risks, and benefits, provide voluntary agreement to participate in the study, and sign the informed consent form (ICF).
• Participants must be willing and able to attend all scheduled follow-up visits and comply with all requirements specified in the study protocol.
• Females of childbearing potential must use highly effective contraception from 1 month prior to vaccination through 12 months following vaccination.
• Effective contraceptive methods include: oral contraceptives (excluding emergency contraceptives), contraceptive injections, subcutaneous implants, hormonal patches, intrauterine devices (IUDs), surgical sterilization, true abstinence, and condom use.
• Methods not considered effective include: rhythm method, withdrawal method, and emergency contraception.

You may not qualify if:

• \*Participants who meet any of the following criteria shall be ineligible for enrollment:
• Axillary body temperature ≥ 37.3 °C.
• History of respiratory syncytial virus (RSV) infection within 6 months prior to enrollment.
• New-onset respiratory infection symptoms within 7 days prior to enrollment, including cough, expectoration, dyspnea, wheezing, fever, rhinorrhea, and nasal obstruction.
• Presence of an acute illness or acute exacerbation of a chronic condition within 3 days prior to enrollment.
• Use of antipyretics and analgesics (excluding enteric-coated aspirin for the prevention of cardiovascular and cerebrovascular diseases) or antiallergic medications within 3 days prior to enrollment.
• Known hypersensitivity to any ingredient of the study vaccine, including Quillaja saponaria (QS-21), 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), cholesterol, sucrose, sodium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, polysorbate 80, sodium chloride, hydrochloric acid, and sodium hydroxide; history of severe allergic reactions or serious adverse events following any vaccination or drug administration, including anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local Arthus reaction, and severe urticaria.
• Pregnant female (positive urine pregnancy test), lactating female, or female with a pregnancy plan within 12 months following vaccination.
• Congenital asplenia, functional asplenia, or splenectomy due to any cause.
• Previous or current malignant neoplasm, with the exception of clinically cured carcinoma in situ and papillary thyroid carcinoma.
• Confirmed diagnosis of an autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, and autoimmune thyroid disease.
• Confirmed or suspected immunosuppression or immunodeficiency resulting from any cause, including primary or secondary immunocompromise, congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, or treatment with immunosuppressive or cytotoxic agents (e.g., chemotherapy, organ transplantation, or therapy for autoimmune diseases).
• Any condition that, in the investigator's judgment, would render intramuscular injection unsafe, such as a history of thrombocytopenia or other coagulation disorders.
• Previous or current serious clinical illness that is not cured (such as serious cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases, diabetes with complications, major surgery, etc.) may affect the evaluation of the trial.
• Previous or current thrombotic diseases.

Sponsors & Collaborators

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

Central Study Contacts

LiangHao Zhang

CONTACT

+86 18971498772; lianghao.zhang@maxvax.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share