Respiratory Syncytial Virus (RSV)Phase 1/2NCT06642558
Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above
A Phase 1/2 study testing Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose) and Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose) in people with Respiratory Syncytial Virus (RSV), run by MAXVAX Biotechnology Limited Liability Company at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 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 Cells)(low dose) and Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 522 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2024to 28 Feb 2027
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Liangyuan District Center for Disease Prevention and Control
Shangqiu, Henan, 476000
About this study
Official title: A Phase I/II, Single Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above
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
- Respiratory Syncytial Virus (RSV)
- Being tested
- Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose), Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose), Placebo (Saline solution)
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 Cells)(low dose)Biological
0.25 mL per dose.
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)Biological
0.5 mL per dose
Placebo (Saline solution)Biological
0.5 mL per dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Placebo (Saline solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The 3rd day after vaccination
Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A
Measured by Virus Neutralization Test.
Measured: 30 days after vaccination
GMT of Neutralizing Antibody against RSV-serotype B
Measured by Virus Neutralization Test.
Measured: 30 days after vaccination
Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A
Compared with the baseline Titer(Day 0).
Measured: 30 days after vaccination
GMFR of Neutralizing Antibody against RSV-serotype B
Compared with the baseline Titer(Day 0).
Measured: 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.
Measured: 30 days after vaccination
GMC of RSV-PreF specific IgG Antibody against RSV-serotype B
Measured by ELISA.
Measured: 30 days after vaccination
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A
Compared with the baseline concentration(Day 0).
Measured: 30 days after vaccination
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B
Compared with the baseline concentration(Day 0).
Measured: 30 days after vaccination
Secondary outcomes (11)
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.
Measured: 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.
Measured: Up to 12 months post vaccination
GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Measured by Virus Neutralization Test.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 30 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start13 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion28 Feb 2027 (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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 522 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
- Investigators
- Lili Huang, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642558
- Sponsor's protocol ID
- MKKCT-900-001
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Single Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above
- ClinicalTrials.gov ID
- NCT06642558
- Acronym / sponsor ID
- MKKCT-900-001
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 522 participants (estimated)
- Lead sponsor
- MAXVAX Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 15 Oct 2024 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Low dose vaccine group in subjects aged 18-59 years - Phase 1 | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)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. |
| High dose vaccine group in subjects aged 18-59 years - Phase 1 | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)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. |
| Placebo group in subjects aged 18-59 years - Phase 1 | Placebo comparator | Biological: Placebo (Saline solution)Subjects aged 18-59 years in phase 1 will receive single dose of placebo, by IM injection into the deltoid region of the arm. |
| Low dose vaccine group in subjects aged ≥60 years - Phase 1 | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)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. |
| High dose vaccine group in subjects aged ≥60 years - Phase 1 | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)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. |
| Placebo group in subjects aged ≥60 years - Phase 1 | Placebo comparator | Biological: Placebo (Saline solution)Subjects aged ≥60 years in phase 1 will receive single dose of placebo, by IM injection into the deltoid region of the arm. |
| Low dose vaccine group in subjects aged 50-59 years - Phase 2 | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)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. |
| High dose vaccine group in subjects aged 50-59 years - Phase 2 | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)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. |
| Placebo group in subjects aged 50-59 years - Phase 2 | Placebo comparator | Biological: Placebo (Saline solution)Subjects aged 50-59 years in phase 2 will receive single dose of placebo, by IM injection into the deltoid region of the arm. |
| Low dose vaccine group in subjects aged ≥60 years - Phase 2 | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)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. |
| High dose vaccine group in subjects aged ≥60 years - Phase 2 | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)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. |
| Placebo group in subjects aged ≥60 years - Phase 2 | Placebo comparator | Biological: Placebo (Saline solution)Subjects aged ≥60 years in phase 2 will receive single dose of placebo, by IM injection into the deltoid region of the arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
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 Cells)(low dose)0.25 mL per dose. | Biological | 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)0.5 mL per dose | Biological | 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)0.5 mL per dose | Biological | 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 |
Primary outcome
Incidence, Intensity and Causality of adverse events(AE)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 30 days after vaccination
Measured by Virus Neutralization Test.
GMT of Neutralizing Antibody against RSV-serotype B
Time frame: 30 days after vaccination
Measured by Virus Neutralization Test.
Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A
Time frame: 30 days after vaccination
Compared with the baseline Titer(Day 0).
GMFR of Neutralizing Antibody against RSV-serotype B
Time frame: 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
Time frame: 30 days after vaccination
Measured by ELISA.
GMC of RSV-PreF specific IgG Antibody against RSV-serotype B
Time frame: 30 days after vaccination
Measured by ELISA.
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A
Time frame: 30 days after vaccination
Compared with the baseline concentration(Day 0).
GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B
Time frame: 30 days after vaccination
Compared with the baseline concentration(Day 0).
11 secondary outcomes
Incidence, Intensity and Causality of SAEs
Time frame: Up to 12 months post vaccination
Incidence, Intensity and Causality of AESI
Time frame: Up to 12 months post vaccination
GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Time frame: 14 days post vaccination-only for phase 1
GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
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
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
Time frame: 14 days post vaccination-only for phase 1
GMT of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
Time frame: At 6, 12, and 24 months post vaccination
GMFR of Neutralizing Antibody against RSV-serotype A and RSV-serotype B
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
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
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
Time frame: 30 days post vaccination
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 6 Jun 2025.
- 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. This study is not recruiting at the moment.
Lili Huang principal investigator
Henan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose) and Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose) in people with Respiratory Syncytial Virus (RSV), run by MAXVAX Biotechnology Limited Liability Company at 1 site in China.
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 5 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, Intensity and Causality of adverse events(AE) (time frame: Within 30 days after vaccination). The study lists 14 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 6 Jun 2025.