Respiratory Syncytial Virus (RSV)Phase 1NCT07807449
Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine （CHO Cell） in Adults Aged 18 Years and Older
A Phase 1 study testing Recombinant RSV Vaccine (CHO Cell), Adjuvant Suspension and Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension in people with Respiratory Syncytial Virus (RSV), run by Yikang Biotech (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This phase 1 study in China will evaluate the Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in 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 RSV Vaccine (CHO Cell), Adjuvant Suspension and Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2026to 22 Jan 2029
- Phase
- Phase 1
- 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
- Adults aged 18 years and older who reside in the local area and can provide legal proof of identity; sex is not restricted;
- Trial participants understand the informed consent form and the vaccine to be administered, voluntarily agree to participate and sign the informed consent form, and are able to use a thermometer and ruler and complete the diary card and contact card as required. If a participant is unable to sign the informed consent form independently because of limited literacy, the informed consent process and signature may be completed with the assistance of an impartial witness;
- Able to communicate effectively with the investigator and understand and comply with all trial requirements;
- Women of childbearing potential (see Appendix 2 for the definition) must have used effective contraception for 2 weeks before enrollment, have a negative urine pregnancy test before investigational vaccine administration (women not of childbearing potential are exempt), and voluntarily agree to continue using at least one effective contraceptive method for 6 months after vaccination. Effective contraception includes oral contraceptives, injectable or implantable contraception, long-acting local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, male condoms, diaphragms, cervical caps, etc. Male trial participants must agree to use effective contraception with female partners of reproductive potential from the screening visit until 6 months after immunization.
Who cannot join
- Trial participants meeting any of the following exclusion criteria may not be enrolled:
- Abnormal pre-vaccination laboratory tests (complete blood count, blood biochemistry, coagulation function, C-reactive protein, or urinalysis) or 12-lead electrocardiogram findings that, based on medical history and clinical presentation, render the person unsuitable for vaccination in the investigator's judgment;
- Abnormal skin at the vaccination sites on both arms at the vaccination visit (e.g., inflammation, induration, erythema/swelling, or extensive scars);
- Hypertension not controlled by medication, or pre-enrollment systolic blood pressure of at least 160 mmHg and/or diastolic blood pressure of at least 100 mmHg;
- Axillary temperature of at least 37.1 degrees C on the day of vaccination; fever, acute illness, or an acute exacerbation of chronic disease within the preceding 3 days; or use of antipyretic/analgesic or anti-allergy medications within the preceding 3 days;
- Communicable period of any infectious disease, acute infection, or acute phase of chronic infection (e.g., active untreated tuberculosis) (by interview);
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- Laboratory-confirmed RSV infection within the previous 12 months, or previous receipt of, or planned receipt of, any marketed or investigational RSV vaccine or RSV monoclonal antibody;
- Documented history of atrial fibrillation;
- History of severe allergic reactions requiring medical intervention [e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrotic reaction (Arthus reaction)]; history of allergy to any component of the investigational vaccine; or history of other severe adverse reactions to vaccination;
- Physician-diagnosed abnormal coagulation function (e.g., coagulation factor deficiency, coagulation disease, or platelet abnormalities) or coagulation disorder that may contraindicate intramuscular injection;
- Anatomic or functional asplenia, or asplenia/splenectomy resulting from any condition;
- Current diagnosed neurologic or psychiatric disorder (including dementia, schizophrenia, or bipolar disorder), previous diagnosis of epilepsy or seizures (excluding febrile seizures in childhood), or other neurologic disease considered unsuitable for trial participation by the investigator;
- Diagnosed congenital or acquired immunodeficiency disease, such as human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, or another immune disease that may affect the trial assessment in the investigator's judgment;
- Long-term use (continuous use for 2 weeks or more) of immunosuppressants or other immunomodulatory medication within 6 months before enrollment or planned within 30 days after vaccination, such as long-term systemic corticosteroid therapy (continuous use for 2 weeks or more at a dose of at least 2 mg/kg/day or at least 20 mg/day of prednisone or equivalent). Topical medication (e.g., ointments, eye drops, inhalants, or nasal sprays) is permitted provided the labeled recommended dose is not exceeded;
- Known serious congenital malformation; developmental disorder or clinically diagnosed serious chronic disease (e.g., Down syndrome, diabetes with complications, sickle cell anemia, or neurologic disease);
- History of immune-mediated demyelinating disease, including but not limited to multiple sclerosis, neuromyelitis optica, acute disseminated encephalomyelitis, transverse myelitis, or Guillain-Barre syndrome;
- Known or suspected serious disease considered by the investigator to affect vaccination, including serious respiratory, digestive, endocrine, immune, cardiovascular, hepatic or renal disease, malignancy, or serious skin disease;
- Pregnant or breastfeeding women, or women planning to conceive within 6 months after vaccination;
- Receipt of blood products, including whole blood, plasma, gamma globulin, or immunoglobulin, within 3 months before vaccination, or plans to receive such treatment during the trial;
- Receipt of a live attenuated vaccine within 28 days before or planned within 28 days after investigational vaccine administration, or receipt of any non-live vaccine within 14 days before or planned within 14 days after investigational vaccine administration;
- Participation in another clinical trial within 6 months before the screening visit, or plans to participate in another clinical trial during this trial;
- Plans to move before the end of the trial or to be away from the local area for an extended period during scheduled trial visits;
- Any condition that, in the investigator's judgment, may affect the trial assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Yixing People's Hospital
Yixing, Jiangsu, 214200
Hongxing Pan, Master, +86-18118996996, panhongxing@126.com
Hongxing Pan, Master
About this study
Official title: A Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Adults Aged 18 Years and Older
This phase 1 study in China will evaluate the Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged 18 Years and Older
Read the detailed description
This is a single-center, randomized, blinded, placebo-controlled trial. A total of 128 trial participants aged 18 years and older will be enrolled: 64 trial participants aged 18-59 years and 64 trial participants aged 60 years and older. Each age stratum will be divided into four cohorts, for a total of eight cohorts: low-dose antigen cohorts, high-dose antigen cohorts , adjuvant-only cohorts, and low-dose antigen + adjuvant cohorts in the 18-59-year and 60-years-and-older strata.
Eligible trial participants in each cohort will be randomized 3:1 on Day 0 to receive one dose of investigational vaccine (low-dose antigen, high-dose antigen, adjuvant, or low-dose antigen + adjuvant) or placebo. Enrollment will proceed in the order of adults (18-59 years) to older adults (60 years and older), low dose to high dose, and antigen to adjuvant to antigen + adjuvant.
To ensure the safety of the study population, the first four trial participants enrolled in each cohort will be designated as sentinel trial participants and randomized 3:1 to investigational vaccine or placebo.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- Recombinant RSV Vaccine (CHO Cell), Adjuvant Suspension, Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension, Saline solution
- Keywords
- RSV vaccine, Acute Respiratory Infection, Lower Respiratory Track Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant RSV Vaccine (CHO Cell)Biological
0.4 mL per dose
Recombinant RSV Vaccine (CHO Cell)Biological
0.8 mL per dose
Adjuvant SuspensionBiological
0.9 mL per dose
Recombinant RSV Vaccine (CHO Cell) with Adjuvant SuspensionBiological
0.9 mL per dose
Saline solutionBiological
0.9 mL per dose
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Antigen Cohort in subjects aged 18-59 years | Experimental | Subjects aged 18-59 years will receive single dose of Recombinant RSV Vaccine (CHO Cell), by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Recombinant RSV Vaccine (CHO Cell) |
| High-Dose Antigen Cohort in subjects aged 18-59 years | Experimental | Subjects aged 18-59 years will receive double dose of Recombinant RSV Vaccine (CHO Cell), by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Recombinant RSV Vaccine (CHO Cell) |
| Adjuvant Cohort in subjects aged 18-59 years | Experimental | Subjects aged 18-59 years will receive single dose of Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Adjuvant Suspension |
| Low-Dose Antigen + Adjuvant Cohort in subjects aged 18-59 years | Experimental | Subjects aged 18-59 years will receive single dose of Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension |
| Placebo group in subjects aged 18-59 years | Placebo comparator | Subjects aged 18-59 years will receive single dose of placebo, by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Saline solution |
| Low-Dose Antigen Cohort in subjects aged ≥60 years | Experimental | Subjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine(CHO Cell), by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Recombinant RSV Vaccine (CHO Cell) |
| High-Dose Antigen Cohort in subjects aged ≥60 years | Experimental | Subjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine(CHO Cell), by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Recombinant RSV Vaccine (CHO Cell) |
| Adjuvant Cohort in subjects aged ≥60 years | Experimental | Subjects aged ≥60 years will receive single dose of Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Adjuvant Suspension |
| Low-Dose Antigen + Adjuvant Cohort in subjects aged ≥60 years | Experimental | Subjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension |
| Placebo group in subjects aged ≥60 years | Placebo comparator | Subjects aged ≥60 years will receive single dose of placebo, by IM injection into the deltoid muscle of the upper arm. Receives: Biological: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of immediate adverse events
Incidence of all adverse events within 30 minutes after vaccination
Measured: Within 30 minutes after vaccination
Incidence of solicited AEs
Incidence of solicited (local and systemic) adverse events within 14 days after vaccination
Measured: Within 0-14 days after vaccination
Incidence of unsolicited AEs
Incidence of unsolicited adverse events within 30 days after vaccination
Measured: Within 30 days after vaccination
Secondary outcomes (18)
Incidence of clinically significant abnormalities in clinical laboratory tests
Incidence of clinically significant abnormal laboratory test results on Day 4 after vaccination
Measured: 4 days after vaccination
Incidence of clinically significant abnormal findings on 12-lead electrocardiograms
Incidence of clinically significant abnormal findings on 12-lead electrocardiograms on Days 4, 14, and 30 after vaccination
Measured: 4 days, 14 days, 30 days after vaccination
Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs) within 24 months after vaccination
Measured: Within 24 months after vaccination
Occurrence of adverse events of special interest (AESIs)
Occurrence of adverse events of special interest (AESIs) within 12 months after vaccination
Measured: Within 12 months after vaccination
GMT of Neutralizing Antibody against RSV serotype A and B
Measured by plaque reduction neutralization test (PRNT)
Measured: 30 days after vaccination
GMFR of Neutralizing Antibody against RSV serotype A and B
Measured by plaque reduction neutralization test (PRNT)
Measured: 30 days after vaccination
SCR of Neutralizing Antibody against RSV serotype A and B
Measured by plaque reduction neutralization test (PRNT)
Measured: 30 days after vaccination
GMC of pre-F protein-binding antibodies
Measured by enzyme-linked immunosorbent assay(ELISA)
Measured: 30 days after vaccination
GMFR of pre-F protein-binding antibodies
Measured by enzyme-linked immunosorbent assay(ELISA)
Measured: 30 days after vaccination
SCR of pre-F protein-binding antibodies
Measured by enzyme-linked immunosorbent assay(ELISA)
Measured: 30 days after vaccination
GMT of Neutralizing Antibody against RSV serotype A and B
Measured by plaque reduction neutralization test (PRNT)
Measured: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
GMFR of Neutralizing Antibody against RSV serotype A and B
Measured by plaque reduction neutralization test (PRNT)
Measured: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
SCR of Neutralizing Antibody against RSV serotype A and B
Measured by plaque reduction neutralization test (PRNT)
Measured: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
GMC of pre-F protein-binding antibodies
Measured by enzyme-linked immunosorbent assay(ELISA)
Measured: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
GMFR of pre-F protein-binding antibodies
Measured by enzyme-linked immunosorbent assay(ELISA)
Measured: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
SCR of pre-F protein-binding antibodies
Measured by enzyme-linked immunosorbent assay(ELISA)
Measured: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
The frequencies of antigen-specific T cells secreting IL-2 and IFN-γ
Measured by ELISpot assay
Measured: 14 days, 30 days after vaccination
The frequencies of antigen-specific CD4+ and CD8+ T cells expressing IL-2 and IFN-γ
Measured by ICS assay
Measured: 14 days, 30 days after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion22 Jan 2027 (estimated)
- Study completion22 Jan 2029 (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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yikang Biotech (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807449
- Sponsor's protocol ID
- V001-RSV-01
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Adults Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT07807449
- Acronym / sponsor ID
- V001-RSV-01
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- RSV vaccine, Acute Respiratory Infection, Lower Respiratory Track Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Yikang Biotech (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 22 Jan 2027 (estimated)
- Study completion
- 22 Jan 2029 (estimated)
- First posted
- 8 Sep 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.
This phase 1 study in China will evaluate the Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged 18 Years and Older
Detailed description
This is a single-center, randomized, blinded, placebo-controlled trial. A total of 128 trial participants aged 18 years and older will be enrolled: 64 trial participants aged 18-59 years and 64 trial participants aged 60 years and older. Each age stratum will be divided into four cohorts, for a total of eight cohorts: low-dose antigen cohorts, high-dose antigen cohorts , adjuvant-only cohorts, and low-dose antigen + adjuvant cohorts in the 18-59-year and 60-years-and-older strata.
Eligible trial participants in each cohort will be randomized 3:1 on Day 0 to receive one dose of investigational vaccine (low-dose antigen, high-dose antigen, adjuvant, or low-dose antigen + adjuvant) or placebo. Enrollment will proceed in the order of adults (18-59 years) to older adults (60 years and older), low dose to high dose, and antigen to adjuvant to antigen + adjuvant.
To ensure the safety of the study population, the first four trial participants enrolled in each cohort will be designated as sentinel trial participants and randomized 3:1 to investigational vaccine or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Antigen Cohort in subjects aged 18-59 years | Experimental | Biological: Recombinant RSV Vaccine (CHO Cell)Subjects aged 18-59 years will receive single dose of Recombinant RSV Vaccine (CHO Cell), by IM injection into the deltoid muscle of the upper arm. |
| High-Dose Antigen Cohort in subjects aged 18-59 years | Experimental | Biological: Recombinant RSV Vaccine (CHO Cell)Subjects aged 18-59 years will receive double dose of Recombinant RSV Vaccine (CHO Cell), by IM injection into the deltoid muscle of the upper arm. |
| Adjuvant Cohort in subjects aged 18-59 years | Experimental | Biological: Adjuvant SuspensionSubjects aged 18-59 years will receive single dose of Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm. |
| Low-Dose Antigen + Adjuvant Cohort in subjects aged 18-59 years | Experimental | Biological: Recombinant RSV Vaccine (CHO Cell) with Adjuvant SuspensionSubjects aged 18-59 years will receive single dose of Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm. |
| Placebo group in subjects aged 18-59 years | Placebo comparator | Biological: Saline solutionSubjects aged 18-59 years will receive single dose of placebo, by IM injection into the deltoid muscle of the upper arm. |
| Low-Dose Antigen Cohort in subjects aged ≥60 years | Experimental | Biological: Recombinant RSV Vaccine (CHO Cell)Subjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine(CHO Cell), by IM injection into the deltoid muscle of the upper arm. |
| High-Dose Antigen Cohort in subjects aged ≥60 years | Experimental | Biological: Recombinant RSV Vaccine (CHO Cell)Subjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine(CHO Cell), by IM injection into the deltoid muscle of the upper arm. |
| Adjuvant Cohort in subjects aged ≥60 years | Experimental | Biological: Adjuvant SuspensionSubjects aged ≥60 years will receive single dose of Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm. |
| Low-Dose Antigen + Adjuvant Cohort in subjects aged ≥60 years | Experimental | Biological: Recombinant RSV Vaccine (CHO Cell) with Adjuvant SuspensionSubjects aged ≥60 years will receive single dose of Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension, by IM injection into the deltoid muscle of the upper arm. |
| Placebo group in subjects aged ≥60 years | Placebo comparator | Biological: Saline solutionSubjects aged ≥60 years will receive single dose of placebo, by IM injection into the deltoid muscle of the upper arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older who reside in the local area and can provide legal proof of identity; sex is not restricted;
- Trial participants understand the informed consent form and the vaccine to be administered, voluntarily agree to participate and sign the informed consent form, and are able to use a thermometer and ruler and complete the diary card and contact card as required. If a participant is unable to sign the informed consent form independently because of limited literacy, the informed consent process and signature may be completed with the assistance of an impartial witness;
- Able to communicate effectively with the investigator and understand and comply with all trial requirements;
- Women of childbearing potential (see Appendix 2 for the definition) must have used effective contraception for 2 weeks before enrollment, have a negative urine pregnancy test before investigational vaccine administration (women not of childbearing potential are exempt), and voluntarily agree to continue using at least one effective contraceptive method for 6 months after vaccination. Effective contraception includes oral contraceptives, injectable or implantable contraception, long-acting local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, male condoms, diaphragms, cervical caps, etc. Male trial participants must agree to use effective contraception with female partners of reproductive potential from the screening visit until 6 months after immunization.
Key exclusion criteria (23 listed)
- Abnormal pre-vaccination laboratory tests (complete blood count, blood biochemistry, coagulation function, C-reactive protein, or urinalysis) or 12-lead electrocardiogram findings that, based on medical history and clinical presentation, render the person unsuitable for vaccination in the investigator's judgment;
- Abnormal skin at the vaccination sites on both arms at the vaccination visit (e.g., inflammation, induration, erythema/swelling, or extensive scars);
- Hypertension not controlled by medication, or pre-enrollment systolic blood pressure of at least 160 mmHg and/or diastolic blood pressure of at least 100 mmHg;
- Axillary temperature of at least 37.1 degrees C on the day of vaccination; fever, acute illness, or an acute exacerbation of chronic disease within the preceding 3 days; or use of antipyretic/analgesic or anti-allergy medications within the preceding 3 days;
- Communicable period of any infectious disease, acute infection, or acute phase of chronic infection (e.g., active untreated tuberculosis) (by interview);
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 RSV Vaccine (CHO Cell)0.4 mL per dose | Biological | Low-Dose Antigen Cohort in subjects aged 18-59 years, Low-Dose Antigen Cohort in subjects aged ≥60 years |
| Recombinant RSV Vaccine (CHO Cell)0.8 mL per dose | Biological | High-Dose Antigen Cohort in subjects aged 18-59 years, High-Dose Antigen Cohort in subjects aged ≥60 years |
| Adjuvant Suspension0.9 mL per dose | Biological | Adjuvant Cohort in subjects aged 18-59 years, Adjuvant Cohort in subjects aged ≥60 years |
| Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension0.9 mL per dose | Biological | Low-Dose Antigen + Adjuvant Cohort in subjects aged 18-59 years, Low-Dose Antigen + Adjuvant Cohort in subjects aged ≥60 years |
| Saline solution0.9 mL per dose | Biological | Placebo group in subjects aged 18-59 years, Placebo group in subjects aged ≥60 years |
Primary outcome
Incidence of immediate adverse events
Time frame: Within 30 minutes after vaccination
Incidence of all adverse events within 30 minutes after vaccination
Incidence of solicited AEs
Time frame: Within 0-14 days after vaccination
Incidence of solicited (local and systemic) adverse events within 14 days after vaccination
Incidence of unsolicited AEs
Time frame: Within 30 days after vaccination
Incidence of unsolicited adverse events within 30 days after vaccination
18 secondary outcomes
Incidence of clinically significant abnormalities in clinical laboratory tests
Time frame: 4 days after vaccination
Incidence of clinically significant abnormal findings on 12-lead electrocardiograms
Time frame: 4 days, 14 days, 30 days after vaccination
Occurrence of serious adverse events (SAEs)
Time frame: Within 24 months after vaccination
Occurrence of adverse events of special interest (AESIs)
Time frame: Within 12 months after vaccination
GMT of Neutralizing Antibody against RSV serotype A and B
Time frame: 30 days after vaccination
GMFR of Neutralizing Antibody against RSV serotype A and B
Time frame: 30 days after vaccination
SCR of Neutralizing Antibody against RSV serotype A and B
Time frame: 30 days after vaccination
GMC of pre-F protein-binding antibodies
Time frame: 30 days after vaccination
GMFR of pre-F protein-binding antibodies
Time frame: 30 days after vaccination
SCR of pre-F protein-binding antibodies
Time frame: 30 days after vaccination
GMT of Neutralizing Antibody against RSV serotype A and B
Time frame: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
GMFR of Neutralizing Antibody against RSV serotype A and B
Time frame: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
SCR of Neutralizing Antibody against RSV serotype A and B
Time frame: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
GMC of pre-F protein-binding antibodies
Time frame: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
GMFR of pre-F protein-binding antibodies
Time frame: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
SCR of pre-F protein-binding antibodies
Time frame: 14 days, 3 months, 6 months,12 months, 18 months and 24 months after vaccination
The frequencies of antigen-specific T cells secreting IL-2 and IFN-γ
Time frame: 14 days, 30 days after vaccination
The frequencies of antigen-specific CD4+ and CD8+ T cells expressing IL-2 and IFN-γ
Time frame: 14 days, 30 days after 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 8 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant RSV Vaccine (CHO Cell), Adjuvant Suspension and Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension in people with Respiratory Syncytial Virus (RSV), run by Yikang Biotech (Suzhou) Co., Ltd. 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 4 inclusion and 23 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 8 Sep 2026. 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 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.
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?
Contact Xuqin Yang, Master (+86-18600534482, yangxuqin@ykangbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of immediate adverse events (time frame: Within 30 minutes after 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 8 Sep 2026.