Active, not recruitingNCT06642558Updated Jun 6, 2025

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

A Phase 1/2 interventional study of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose) and Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose) in Respiratory Syncytial Virus (RSV), sponsored by MAXVAX Biotechnology Limited Liability Company. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by MAXVAX Biotechnology Limited Liability Company · Phase 1/2, Interventional, and Prevention

From the registry’s dates

Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 522
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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.

Read the detailed description

A total of 522 subjects in the phase 1/2 study will be enrolled. The study will be conducted in 2 parts (phase 1 for dose escalation and phase 2 for expansion), with first evaluation of safety of 2 two dose levels of Recombinant RSV vaccine(CHO cells) in healthy participants aged 18-59 and ≥60 in phase 1 before preceding with vaccination of the participants aged 50-59 and ≥60 in phase 2. To ensure the safety of the study participants, phase 1 will follow a staggered enrolment with 3 steps. All subjects in each age group in phase 1 will be randomly receive the investigational vaccine(half or full dose) and the placebo in a 2:1 ratio, while all subjects in each age group in phase 2 will be randomly receive the half dose vaccine, the full dose vaccine and the placebo in a 1:1:1 ratio.

Conditions studied

Respiratory Syncytial Virus (RSV)

In context

Lead sponsor

MAXVAX Biotechnology Limited Liability Company is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;
Administration of long-acting immune-modifying drugs(e.g. Infliximab) or planned administration at any time during the study period;
Administration of immunoglobulins and/or any blood products during the period starting 3 months before vaccination or planned administration during the study period;
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;
History of alcohol or drug abuse;
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;
Planned move to a location that will prohibit participating in the trial until study end;
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);
At screening: Any electrocardiogram abnormal and clinically significant in the judgment of the investigator (Only for phase 1);
Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 522 participants (estimated)

Study arms

Experimental
Low dose vaccine group in subjects aged 18-59 years - Phase 1
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)
Experimental
High dose vaccine group in subjects aged 18-59 years - Phase 1
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 comparator
Placebo group in subjects aged 18-59 years - Phase 1
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)
Experimental
Low dose vaccine group in subjects aged ≥60 years - Phase 1
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)
Experimental
High dose vaccine group in subjects aged ≥60 years - Phase 1
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 comparator
Placebo group in subjects aged ≥60 years - Phase 1
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)
Experimental
Low dose vaccine group in subjects aged 50-59 years - Phase 2
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)
Experimental
High dose vaccine group in subjects aged 50-59 years - Phase 2
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 comparator
Placebo group in subjects aged 50-59 years - Phase 2
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)
Experimental
Low dose vaccine group in subjects aged ≥60 years - Phase 2
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)
Experimental
High dose vaccine group in subjects aged ≥60 years - Phase 2
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 comparator
Placebo group in subjects aged ≥60 years - Phase 2
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

BiologicalRecombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)
0.25 mL per dose.
BiologicalRecombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)
0.5 mL per dose
BiologicalPlacebo (Saline solution)
0.5 mL per dose

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The 3rd day after vaccination
Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A
Measured by Virus Neutralization Test.
Time frame: 30 days after vaccination
GMT of Neutralizing Antibody against RSV-serotype B
Measured by Virus Neutralization Test.
Time frame: 30 days after vaccination
Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A
Compared with the baseline Titer(Day 0).
Time frame: 30 days after vaccination
GMFR of Neutralizing Antibody against RSV-serotype B
Compared with the baseline Titer(Day 0).
Time frame: 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.
Time frame: 30 days after vaccination
GMC of RSV-PreF specific IgG Antibody against RSV-serotype B
Measured by ELISA.
Time frame: 30 days after vaccination
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A
Compared with the baseline concentration(Day 0).
Time frame: 30 days after vaccination
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B
Compared with the baseline concentration(Day 0).
Time frame: 30 days after vaccination

Secondary outcomes

Incidence, Intensity and Causality of 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.
Time frame: Up to 12 months post vaccination
Incidence, Intensity and Causality of AESI
Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.
Time frame: Up to 12 months post vaccination
GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Measured by Virus Neutralization Test.
Time frame: 14 days post vaccination-only for phase 1
GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Compared with the baseline Titer(Day 0).
Time frame: 14 days post vaccination-only for phase 1
GMC of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B
Measured by ELISA.
Time frame: 14 days post vaccination-only for phase 1
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B
Compared with the baseline concentration(Day 0).
Time frame: 14 days post vaccination-only for phase 1
GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Measured by Virus Neutralization Test.
Time frame: At 6, 12, and 24 months post vaccination
GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Compared with the baseline Titer(Day 0).
Time frame: At 6, 12, and 24 months post vaccination
GMC of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B
Measured by ELISA.
Time frame: At 6, 12, and 24 months post vaccination
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B
Compared with the baseline concentration(Day 0).
Time frame: At 6, 12, and 24 months post vaccination
The Frequency of RSV-PreF Specific Cluster of Differentiation 4+ (CD4+) T Cells or Cluster of Differentiation 8+ (CD8+) T cells Expressing at Least 2 Markers - only for phase 2
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.
Time frame: 30 days post vaccination

Study locations

1 site

Liangyuan District Center for Disease Prevention and Control
Shangqiu, Henan 476000, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06642558
Lead sponsor: MAXVAX Biotechnology Limited Liability Company
Collaborators: Henan Center for Disease Control and Prevention
Responsible party: Sponsor
First posted: Oct 15, 2024
Start date: Nov 13, 2024
Primary completion: Jun 30, 2025 (estimated)
Completion: Feb 28, 2027 (estimated)
Last update: Jun 6, 2025

Study contacts

Lili Huang

principal investigator · Henan Center for Disease Control and Prevention

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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