Respiratory Syncytial Virus (RSV)NCT07618325
A Study to Evaluate the Immune Response Features Following Vaccination With a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)
A study testing Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in people with Respiratory Syncytial Virus (RSV), run by MAXVAX Biotechnology Limited Liability Company.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- History of untreated tuberculosis or active tuberculosis infection at enrollment.
- Uncontrolled hypertension defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg on measurement prior to vaccination.
- History of severe cardiac arrhythmia (e.g., atrial fibrillation).
- History or family history of convulsions, epilepsy, congenital brain malformation, psychiatric disorders, or other severe neurological conditions associated with cerebral nerve tissue injury, including brain tumor, cerebral hemorrhage, cerebral infarction (excluding lacunar cerebral infarction and cerebral infarction without sequelae), central nervous system infection, and chemical intoxication.
- History of any cognitive disorder or any moderate or severe condition causing cognitive impairment.
- Use of any investigational or unlicensed product (medicinal product, vaccine, or medical device) other than the study vaccine within 30 days prior to vaccination, or planned participation in another clinical trial during the study period.
- Administration of any inactivated vaccine within 14 days prior to vaccination, or any live vaccine within 28 days prior to vaccination.
- Prior receipt of any RSV vaccine.
- Administration of immunoglobulin and/or any blood or plasma derivative (e.g., gamma globulin, intravenous immunoglobulin) within 3 months prior to vaccination, or planned administration during the study period.
- Long-term use (consecutive use > 14 days) of immunosuppressive or other immunomodulatory agents within 3 months prior to vaccination or planned use during the study period. Systemic glucocorticoids ≥ 20 mg prednisone or equivalent daily for ≥ 14 days are considered long-term use. Topical preparations (ointments, eye drops, inhalations, nasal sprays) at doses not exceeding those recommended in the package insert are permitted.
- Use of long-acting immunomodulatory agents (e.g., infliximab) within 6 months prior to vaccination or planned use during the study period.
- History of chronic alcohol abuse and/or drug abuse that, in the investigator's judgment, may interfere with study assessments.
- Planned migration during the study period that would preclude completion of all study procedures.
- Any other condition that, in the investigator's judgment, may interfere with the validity of study evaluations, with special attention to respiratory infection symptoms.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Novel adjuvants can effectively induce humoral immunity and generate neutralizing antibodies, as well as activate cellular immunity to clear intracellular pathogens.They mainly include particle-based adjuvants based on molecular agonists, synthetic inorganic/organic particulate materials, and virus-like particle mimetics.This study focuses on the mechanisms by which adjuvants enhance humoral and cellular immunity, analyzes antibody lineages, structural characteristics, and the patterns of T-cell activation, differentiation and memory formation, and elucidates the regulatory effects of adjuvants on antibody breadth and neutralizing activity. This study aims to systematically study the role of RSV adjuvants in enhancing high-affinity antibody responses and CD4⁺/CD8⁺ memory T cell generation through multi-dimensional immune analysis methods, including B Cell Receptor (BCR) / T Cell Receptor (TCR) sequencing, flow cytometry, and single-cell omics, so as to provide theoretical basis and new ideas for improving the sustainability and broad-spectrum immunization effect of novel RSV vaccines. A total of 60 adults aged 20 years and above will be enrolled. All participants will receive a single dose of investigational vaccine.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)Biological
0.5 mL per dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing Antibodies against both the RSV-A and RSV-B subtypes.
Measured by Virus Neutralization Test.
Measured: 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.
Measured: 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).
Measured: At pre-vaccination (Day 1), and at 1 month, 12 months, and 24 months post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start2 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MAXVAX Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618325
- Sponsor's protocol ID
- MKKCT-900-005
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Immune Response Features Following Vaccination With a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)
- ClinicalTrials.gov ID
- NCT07618325
- Acronym / sponsor ID
- MKKCT-900-005
- Conditions
- Respiratory Syncytial Virus (RSV)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MAXVAX Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Study start
- 2 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Novel adjuvants can effectively induce humoral immunity and generate neutralizing antibodies, as well as activate cellular immunity to clear intracellular pathogens.They mainly include particle-based adjuvants based on molecular agonists, synthetic inorganic/organic particulate materials, and virus-like particle mimetics.This study focuses on the mechanisms by which adjuvants enhance humoral and cellular immunity, analyzes antibody lineages, structural characteristics, and the patterns of T-cell activation, differentiation and memory formation, and elucidates the regulatory effects of adjuvants on antibody breadth and neutralizing activity. This study aims to systematically study the role of RSV adjuvants in enhancing high-affinity antibody responses and CD4⁺/CD8⁺ memory T cell generation through multi-dimensional immune analysis methods, including B Cell Receptor (BCR) / T Cell Receptor (TCR) sequencing, flow cytometry, and single-cell omics, so as to provide theoretical basis and new ideas for improving the sustainability and broad-spectrum immunization effect of novel RSV vaccines. A total of 60 adults aged 20 years and above will be enrolled. All participants will receive a single dose of investigational vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine Group | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)Participants will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell), by IM injection into the deltoid muscle of the upper arm. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)0.5 mL per dose | Biological | Vaccine Group |
Primary outcome
Neutralizing Antibodies against both the RSV-A and RSV-B subtypes.
Time frame: At pre-vaccination (Day 1), and at 1, 12, and 24 months post-vaccination.
Measured by Virus Neutralization Test.
Specific IgG Antibodies to RSV pre-F of both RSV-A and RSV-B subtypes.
Time frame: At pre-vaccination (Day 1), and at 1 month, 12 months, and 24 months post-vaccination.
Measured by ELISA.
The Frequency of RSV pre-F Specific Cluster of Differentiation 4+ (CD4+) T Cells or Cluster of Differentiation 8+ (CD8+) T cells Expressing.
Time frame: At pre-vaccination (Day 1), and at 1 month, 12 months, and 24 months post-vaccination.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in people with Respiratory Syncytial Virus (RSV), run by MAXVAX Biotechnology Limited Liability Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LiangHao Zhang (+86 18971498772, lianghao.zhang@maxvax.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutralizing Antibodies against both the RSV-A and RSV-B subtypes. (time frame: At pre-vaccination (Day 1), and at 1, 12, and 24 months post-vaccination.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.