Respiratory Syncytial Virus InfectionsPhase 1/2NCT07582796
Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.
A Phase 1/2 study testing Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted), Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) and Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant) in people with Respiratory Syncytial Virus Infections, run by Ab&B Bio-tech Co., Ltd.JS at 1 site in China.
Trial summary
The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. 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 Infections
- What is being tested?
- Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted), Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) and Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2026to 14 Aug 2029
- 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
- Males or females aged 18 years and older at the time of enrollment (aged 18 years and older for the phase I part; aged 60 years and older for the phase II part), who are able to provide legal proof of identity.
- Voluntarily agree to participate in the trial, able to fully understand and sign the informed consent form.
- Able to attend all scheduled follow-up visits and comply with the requirements of the clinical trial protocol to complete the study.
- Female participants must meet the following criteria: In the phase I part, women of childbearing potential* must have a negative pregnancy test prior to enrollment and be willing to use effective contraceptive measures for 12 months after receiving the investigational vaccine; in the phase II part, only women of non-childbearing potential will be enrolled.
- Women of childbearing potential: Defined as females who have experienced menarche and have not yet entered menopause, unless permanently sterile, such as documented bilateral salpingectomy, bilateral oophorectomy, or hysterectomy; menopause is defined as amenorrhea for 12 consecutive months without other medical cause.
- [Effective contraceptive measures include: oral contraceptives, injectable contraceptives, subdermal implants or hormonal patches, intrauterine device (IUD), sterilization surgery, abstinence (no sexual intercourse), male condoms, etc.; rhythm method, withdrawal, and emergency contraception are not considered effective contraceptive measures.]
- Axillary body temperature ≤ 37.0°C measured on site prior to vaccination on the day of vaccination.
Who cannot join
- Clinically significant laboratory abnormalities that, in the investigator's comprehensive judgment, preclude enrollment (applicable only to the phase I part).
- Pregnant or breastfeeding women.
- A clear diagnosis of RSV infection or a history of RSV infection-related respiratory disease within 6 months prior to vaccination.
- Use of immunoglobulins or/and any blood products or plasma derivatives within 3 months prior to vaccination, or planned use during the study.
- Treatment with immunomodulators (including immunosuppressants and immunostimulants) within 6 months prior to vaccination (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent) (excluding inhaled, intra-articular, and topical steroids).
- Administration or planned use of long-acting immunomodulatory drugs (e.g., infliximab) at any time during the study.
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- A history of severe allergic reactions (e.g., anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, Arthus reaction) following any previous vaccination or drug use, or a family history of severe allergies.
- Impaired immune function or a diagnosis of congenital or acquired immunodeficiency, or human immunodeficiency virus (HIV) infection.
- A personal or family history of convulsions, epilepsy, encephalopathy, psychiatric disorders, or neurological diseases (such as Guillain-Barré syndrome, Miller Fisher syndrome).
- A diagnosis of lymphoproliferative disease or malignant tumor within 5 years.
- Clinically significant electrocardiogram (ECG) abnormalities as determined by the investigator (applicable only to the phase I part).
- Previous vaccination with any licensed or investigational RSV vaccine prior to enrollment, or planned vaccination during the study.
- Receipt of any vaccine within 14 days prior to vaccination, or any live vaccine within 30 days prior to vaccination.
- An acute disease or an acute exacerbation of a chronic disease within 3 days prior to vaccination, or use of antipyretic, analgesic, or anti-allergy medications.
- Suspected or known alcohol abuse or alcohol dependence (referring to a drinking pattern that causes serious mental or physical health problems) or drug abuse.
- A history of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection.
- Severe or unstable chronic diseases, including but not limited to cardiovascular diseases [e.g., hypertension uncontrolled by medication (on-site blood pressure measurement prior to vaccination: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), coronary heart disease, myocarditis, pericarditis, atrial fibrillation], metabolic diseases (e.g., poorly controlled diabetes), hematological disorders (e.g., severe anemia, hemophilia), hepatic or renal diseases, digestive system diseases, respiratory system diseases (e.g., chronic obstructive pulmonary disease, active pulmonary tuberculosis, other severe respiratory diseases).
- Note: For participants aged 60 years and older, those with pre-existing stable disease may be enrolled. This is defined as participants who may have underlying conditions such as hypertension or diabetes, provided that symptoms and signs are stable and medically controllable as assessed by the investigator prior to vaccination, and who have not required changes to the treatment/medication regimen or hospitalization due to the underlying condition within 3 months.
- A history of confirmed immune-mediated/autoimmune diseases (e.g., cold agglutinin hemolytic anemia, lymphadenopathy, eosinophilia, systemic lupus erythematosus, gout, hyperuricemia, acute disseminated encephalomyelitis, immune thrombocytopenia, autoimmune aplastic anemia, autoimmune neutropenia, autoimmune lymphoproliferative syndrome, thrombocytopenic purpura).
- Asplenia or functional asplenia, as well as any condition resulting in asplenia or splenectomy.
- Currently participating in or planning to participate in another clinical study involving investigational or unregistered products (drugs, vaccines, medical devices, etc.) during this study.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in this clinical trial.
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, 1 recruiting
- Recruiting
Zigong Center for Disease Control and Prevention
Zigong, Sichuan
Xue Zhao, Master, 18168168075, zhaoxue@abbbio.com.cn
Ting Huang, Bachelor
About this study
Official title: A Randomized, Blinded, Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) (Adjuvanted) in Adults Aged 18 Years and Older.
The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted), Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant), Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant), Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted), Normal Saline
- Keywords
- Respiratory syncytial virus, Safety, RSV vaccine, Immunogenicity
- Medical subject headings
- Respiratory Syncytial Virus Infections
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)(Adjuvanted)Biological
The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)Biological
The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant)Biological
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted)Biological
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)Biological
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Normal SalineBiological
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant)Biological
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Vaccine 1 (Low Dose) Group | Experimental | Not described Receives: Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted) |
| Investigational Vaccine 2 (Low Dose) Group | Experimental | Not described Receives: Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) |
| Investigational Vaccine 1 Group | Experimental | Not described Receives: Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted) |
| Investigational Vaccine 2 Group | Experimental | Not described Receives: Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) |
| Investigational Vaccine 3 Group | Experimental | Not described Receives: Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant) |
| Adjuvant Control Group | Placebo comparator | Not described Receives: Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant) |
| Placebo Group | Placebo comparator | Not described Receives: Biological: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination.
Measured: Within 14 days post-vaccination.
Incidence of unsolicited AEs within 30 days post-vaccination.
Measured: Within 30 days post-vaccination.
Incidence of clinically significant laboratory abnormalities(blood biochemistry, blood routine, coagulation function, urinalysis) on Day 3 post-vaccination, and incidence of clinically significant ECG abnormalities on Days 3, 14, and 30 post-vaccination.
Applicable to Phase I only
Measured: On Days 3, 14, and 30 post-vaccination
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post-vaccination.
Measured: Within 12 months post-vaccination.
At 1 month post-vaccination: geometric mean titer (GMT) of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: seroresponse rate (SRR) of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: geometric mean fold rise (GMFR) of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: geometric mean concentration (GMC) of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Measured: At 1 month post-vaccination
Secondary outcomes (13)
At 1 month post-vaccination: GMT of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: SRR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: GMFR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: GMC of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase I only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase I only
Measured: At 1 month post-vaccination
At 1 month post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase I only
Measured: At 1 month post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMT of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Measured: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: SRR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Measured: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMFR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Measured: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMC of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Measured: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Measured: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Measured: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 1 month, and 6 months post-vaccination: counts of CD4+ and CD8+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L)
Applicable to Phase Ⅱ only
Measured: At 14 days, 1 month, and 6 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 posted13 May 2026
- Study start14 May 2026
- Primary completion14 Sep 2027 (estimated)
- Study completion14 Aug 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 InfectionsStudies 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
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Collaborators
- Yither Biotech Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Ting Huang, Bachelor, Principal investigator, Sichuan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582796
- Sponsor's protocol ID
- aRSV-ZHSW-01
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 27 May 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) (Adjuvanted) in Adults Aged 18 Years and Older.
- ClinicalTrials.gov ID
- NCT07582796
- Acronym / sponsor ID
- aRSV-ZHSW-01
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory syncytial virus, Safety, RSV vaccine, Immunogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Collaborators
- Yither Biotech Co., Ltd
- Study start
- 14 May 2026 (actual)
- Primary completion
- 14 Sep 2027 (estimated)
- Study completion
- 14 Aug 2029 (estimated)
- First posted
- 13 May 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 primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Investigational Vaccine 1 (Low Dose) Group | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted) |
| Investigational Vaccine 2 (Low Dose) Group | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) |
| Investigational Vaccine 1 Group | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted) |
| Investigational Vaccine 2 Group | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) |
| Investigational Vaccine 3 Group | Experimental | Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant) |
| Adjuvant Control Group | Placebo comparator | Biological: Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant) |
| Placebo Group | Placebo comparator | Biological: Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females aged 18 years and older at the time of enrollment (aged 18 years and older for the phase I part; aged 60 years and older for the phase II part), who are able to provide legal proof of identity.
- Voluntarily agree to participate in the trial, able to fully understand and sign the informed consent form.
- Able to attend all scheduled follow-up visits and comply with the requirements of the clinical trial protocol to complete the study.
- Female participants must meet the following criteria: In the phase I part, women of childbearing potential* must have a negative pregnancy test prior to enrollment and be willing to use effective contraceptive measures for 12 months after receiving the investigational vaccine; in the phase II part, only women of non-childbearing potential will be enrolled.
- [Effective contraceptive measures include: oral contraceptives, injectable contraceptives, subdermal implants or hormonal patches, intrauterine device (IUD), sterilization surgery, abstinence (no sexual intercourse), male condoms, etc.; rhythm method, withdrawal, and emergency contraception are not considered effective contraceptive measures.]
Key exclusion criteria (22 listed)
- Clinically significant laboratory abnormalities that, in the investigator's comprehensive judgment, preclude enrollment (applicable only to the phase I part).
- Pregnant or breastfeeding women.
- A clear diagnosis of RSV infection or a history of RSV infection-related respiratory disease within 6 months prior to vaccination.
- Use of immunoglobulins or/and any blood products or plasma derivatives within 3 months prior to vaccination, or planned use during the study.
- Treatment with immunomodulators (including immunosuppressants and immunostimulants) within 6 months prior to vaccination (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent) (excluding inhaled, intra-articular, and topical steroids).
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)(Adjuvanted)The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0. | Biological | Investigational Vaccine 1 (Low Dose) Group |
| Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0. | Biological | Investigational Vaccine 2 (Low Dose) Group |
| Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant)The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0. | Biological | Adjuvant Control Group |
| Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted)The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0. | Biological | Investigational Vaccine 1 Group |
| Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0. | Biological | Investigational Vaccine 2 Group |
| Normal SalineThe vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0. | Biological | Placebo Group |
| Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant)The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0. | Biological | Investigational Vaccine 3 Group |
Primary outcome
Incidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination.
Time frame: Within 14 days post-vaccination.
Incidence of unsolicited AEs within 30 days post-vaccination.
Time frame: Within 30 days post-vaccination.
Incidence of clinically significant laboratory abnormalities(blood biochemistry, blood routine, coagulation function, urinalysis) on Day 3 post-vaccination, and incidence of clinically significant ECG abnormalities on Days 3, 14, and 30 post-vaccination.
Time frame: On Days 3, 14, and 30 post-vaccination
Applicable to Phase I only
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post-vaccination.
Time frame: Within 12 months post-vaccination.
At 1 month post-vaccination: geometric mean titer (GMT) of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 1 month post-vaccination
Applicable to Phase Ⅱ only
At 1 month post-vaccination: seroresponse rate (SRR) of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 1 month post-vaccination
Applicable to Phase Ⅱ only
At 1 month post-vaccination: geometric mean fold rise (GMFR) of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 1 month post-vaccination
Applicable to Phase Ⅱ only
At 1 month post-vaccination: geometric mean concentration (GMC) of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 1 month post-vaccination
Applicable to Phase Ⅱ only
At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 1 month post-vaccination
Applicable to Phase Ⅱ only
At 1 month post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 1 month post-vaccination
Applicable to Phase Ⅱ only
13 secondary outcomes
At 1 month post-vaccination: GMT of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: SRR of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: GMFR of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: GMC of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 1 month post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMT of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: SRR of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMFR of neutralizing antibodies against RSV-A and RSV-B.
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMC of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 1 month, and 6 months post-vaccination: counts of CD4+ and CD8+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L)
Time frame: At 14 days, 1 month, and 6 months 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 27 May 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.
Ting Huang, Bachelor principal investigator
Sichuan 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 cell)(Adjuvanted), Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) and Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant) in people with Respiratory Syncytial Virus Infections, run by Ab&B Bio-tech Co., Ltd.JS 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 7 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 27 May 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 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?
Contact Xue Zhao, Master (18168168075, zhaoxue@abbbio.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination. (time frame: Within 14 days post-vaccination.). The study lists 10 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 27 May 2026.