Respiratory Syncytial Virus InfectionPhase 1NCT06904222

Safety and Immunogenicity of the Recombinant Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 18 Years and Older

A Phase 1 study testing Low dose antigen of LYB005 without A01B adjuvant, Low dose antigen of LYB005 with A01B adjuvant and Middle dose antigen of LYB005 without A01B adjuvant in people with Respiratory Syncytial Virus Infection, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase 1 study in China will evaluate the safety and immunogenicity of the the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 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 Infection
What is being tested?: Low dose antigen of LYB005 without A01B adjuvant, Low dose antigen of LYB005 with A01B adjuvant and Middle dose antigen of LYB005 without A01B adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteChina
Study dates: 15 Apr 2025to Aug 2026
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

Residents aged 18 years and older (at the time of screening), regardless of gender;
Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form, and are able to attend all planned follow-up visits and comply with the protocol requirements;
Axillary temperature < 37.3°C on the day of enrollment;
Females of childbearing potential should use effective contraceptive measures one month before enrollment; females of childbearing potential (excluding those who have undergone tubal ligation, bilateral oophorectomy, or hysterectomy) and male participants should practice effective contraception and avoid pregnancy plans, as well as sperm or egg donation plans from the time of enrollment until 6 months after the full course of vaccination. Effective contraceptive methods include oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.

Who cannot join

Allergy to the investigational vaccine or its excipients, or a history of anaphylactic shock or other serious adverse reactions to other vaccines;
Previous vaccination against Respiratory Syncytial Virus;
A confirmed diagnosis or etiological evidence of respiratory syncytial virus infection and related diseases caused by the infection within 12 months before enrollment;
Has taken antipyretics, analgesics or anti-allergy drugs within 24 hours before enrollment;
Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
Has received blood or blood-related products, including immunoglobulin, within 3 months prior to enrollment; or plan to use them during the study period;

Show all 21Show fewer

Individual with the following diseases:
Has acute diseases or are in the acute exacerbation period of chronic diseases within 3 days before vaccination;
Diagnosed with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
History of congenital or acquired immunodeficiency or autoimmune diseases;
Chronic administration (≥14 consecutive days) of corticosteroids (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (<14 consecutive days) of oral corticosteroids;
Neurological diseases or family history (seizures, epilepsy, encephalopathy, etc.); history of psychiatric disorders or family history;
Asplenia or functional asplenia;
Severe or uncontrolled or hospitalization-required cardiovascular diseases, diabetes, blood and lymphatic system diseases, immune system diseases, liver and kidney diseases, respiratory system diseases, metabolic and skeletal system diseases, or malignant tumors;
Contraindications for intramuscular injection and blood drawing, such as coagulation disorders, thrombosis or hemorrhagic diseases, or situations requiring continuous use of anticoagulants;
Severe hypertension that cannot be controlled by medication (measured on-site: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
History of major surgery within 12 weeks prior to enrollment (as determined by the investigator), or not fully recovered from the surgery, or having plans for major surgery during the anticipated period of the subject's participation in the study;
History of long-term alcohol abuse and/or drug abuse;
Individual who is currently participating in other research or unregistered product (drugs, vaccines, or devices, etc.) clinical studies, or plan to participate in other clinical studies before the end of this clinical study;
Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator;
Exclusion criteria for specific populations: lactating or pregnant women during the clinical research period, or women of childbearing age with a positive pregnancy test before vaccination.

Trial locations and contacts

1 site in 1 country.

China1 site

Dangyang City Center for Disease Control and Prevention
Dangyang

Other trials in China

About this study

Official title: A Phase I, Randomized, Observer-blinded, Placebo-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in Adults Aged 18 Years and Older

This phase 1 study in China will evaluate the safety and immunogenicity of the the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in adults aged 18 years and older.

Read the detailed description

A randomized, observer-blinded, placebo-controlled, dose escalation trial will be conducted to observe the safety and immunogenicity of LYB005 in adults aged 18 years and older. A total of 90 healthy subjects will be enrolled and stratified by age (18-59 years and ≥60 years in a 1:1 ratio). Six formulations of LYB005 will be provided, three dose levels of antigen with or without A01B adjuvant.

A sentinel and escalating dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be enrolled in one of six cohorts, including Cohort 1 (18-59 years, low dose, n=15), Cohort 2 (18-59 years, middle dose, n=15), Cohort 3 (≥60 years, low dose, n=15), Cohort 4 (18-59 years, high dose, n=15), Cohort 5 (≥60 years, middle dose, n=15), and Cohort 6 (≥60 years, high dose, n=15). In each cohort, five sentinels were set up, and they were randomly vaccinated with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo in a 2:2:1 ratio. The remaining participants were randomly vaccinated in a 2:2:1 ratio with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo. A single-dose immunization schedule will be adopted.

Conditions: Respiratory Syncytial Virus Infection
Being tested: Low dose antigen of LYB005 without A01B adjuvant, Low dose antigen of LYB005 with A01B adjuvant, Middle dose antigen of LYB005 without A01B adjuvant, Middle dose antigen of LYB005 with A01B adjuvant, High dose antigen of LYB005 without A01B adjuvant
Keywords: Respiratory Syncytial Virus, Acute Respiratory Infection, Lower Respiratory Track Disease
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.

Low dose antigen of LYB005 without A01B adjuvantBiological
0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.
Low dose antigen of LYB005 with A01B adjuvantBiological
0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.
Middle dose antigen of LYB005 without A01B adjuvantBiological
0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.
Middle dose antigen of LYB005 with A01B adjuvantBiological
0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.
High dose antigen of LYB005 without A01B adjuvantBiological
0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.
High dose antigen of LYB005 with A01B adjuvantBiological
0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.
PlaceboBiological
0.5 mL 0.9% sodium chloride (normal saline) injection per dose

Study groups in NCT06904222
Study group	Role	What they receive
Low dose antigen of LYB005 without A01B adjuvant	Experimental	Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen without A01B adjuvant) at Day 0. Receives: Biological: Low dose antigen of LYB005 without A01B adjuvant
Low dose antigen of LYB005 with A01B adjuvant	Experimental	Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen with A01B adjuvant) at Day 0. Receives: Biological: Low dose antigen of LYB005 with A01B adjuvant
Middle dose antigen of LYB005 without A01B adjuvant	Experimental	Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen without A01B adjuvant) at Day 0. Receives: Biological: Middle dose antigen of LYB005 without A01B adjuvant
Middle dose antigen of LYB005 with A01B adjuvant	Experimental	Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen with A01B adjuvant) at Day 0. Receives: Biological: Middle dose antigen of LYB005 with A01B adjuvant
High dose antigen of LYB005 without A01B adjuvant	Experimental	Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen without A01B adjuvant) at Day 0. Receives: Biological: High dose antigen of LYB005 without A01B adjuvant
High dose antigen of LYB005 with A01B adjuvant	Experimental	Subjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen with A01B adjuvant) at Day 0. Receives: Biological: High dose antigen of LYB005 with A01B adjuvant
Placebo	Placebo comparator	Subjects aged 18 years and older will be vaccinated with 1 dose of placebo at Day 0. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of immediate adverse events
The incidence and severity of any adverse events (AEs) within 30 minutes after vaccination
Measured: Within 30 minutes after vaccination
Incidence of solicited AE
Occurrence and severity of solicited local injection site reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., pain, redness, swelling).
Occurrence and severity of solicited systemic reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., myalgia, fatigue, headache, chills, fever).
Measured: Within 0-7 days after vaccination
Incidence of unsolicited AEs
The incidence and severity of any unsolicited AEs, including all AEs, except solicited AEs reported Days 0~28 after the vaccination.
Measured: Within 28 days after vaccination
Incidence of clinically significant abnormalities in clinical laboratory tests
The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, coagulation function, and urinalysis) on Day 3 after vaccination.
Measured: 3 days after vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
The incidence of any SAEs and AESIs from the first vaccination up to 12 months after vaccination.
Measured: 12 months after vaccination

Secondary outcomes (4)

The geometric mean titer (GMT) of Neutralizing Antibodies Against RSV A and RSV B
Measured by microneutralization assay.
Measured: 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B
Change from prevaccination in geometric mean fold rise of Neutralizing antibody titer Against RSV A and RSV B
Measured: 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
The geometric mean concentration (GMC) for Pre-fusion Protein Specific Binding Antibodies
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Number of Pre-fusion Protein Specific Interferon-gamma and Interleukin-4 spot-forming cells
T-cell responses to vaccine antigen in peripheral blood mononuclear cells (PBMCs) determined by enzyme-linked immunosorbent spot (ELISpot).
Measured: 28 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 2025Aug 2026

First posted1 Apr 2025
Study start15 Apr 2025
Primary completionAug 2026 (estimated)
Study completionAug 2026 (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 InfectionStudies 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
Model description: Participants will be enrolled in one of six cohorts, including Cohort 1 (18-59 years, low dose, n=15), Cohort 2 (18-59 years, middle dose, n=15), Cohort 3 (≥60 years, low dose, n=15), Cohort 4 (18-59 years, high dose, n=15), Cohort 5 (≥60 years, middle dose, n=15), and Cohort 6 (≥60 years, high dose, n=15). In each cohort, five sentinels were set up, and they were randomly vaccinated with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo in a 2:2:1 ratio. The remaining participants were randomly vaccinated in a 2:2:1 ratio with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo. For both sentinels and remaining participants, the investigational vaccine group and the control group (placebo) are enrolled parallelly.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06904222
Sponsor's protocol ID: LYB005/CT-CHN-101
Status last verified: Aug 2025
First submitted: 24 Mar 2025
Last updated: 22 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Syncytial Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Observer-blinded, Placebo-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in Adults Aged 18 Years and Older
ClinicalTrials.gov ID: NCT06904222
Acronym / sponsor ID: LYB005/CT-CHN-101
Conditions: Respiratory Syncytial Virus Infection
Keywords: Respiratory Syncytial Virus, Acute Respiratory Infection, Lower Respiratory Track Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 90 participants (estimated)
Lead sponsor: Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Apr 2025 (actual)
Primary completion: Aug 2026 (estimated)
Study completion: Aug 2026 (estimated)
First posted: 1 Apr 2025 (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 immunogenicity of the the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in adults aged 18 years and older.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 7
Model description: Participants will be enrolled in one of six cohorts, including Cohort 1 (18-59 years, low dose, n=15), Cohort 2 (18-59 years, middle dose, n=15), Cohort 3 (≥60 years, low dose, n=15), Cohort 4 (18-59 years, high dose, n=15), Cohort 5 (≥60 years, middle dose, n=15), and Cohort 6 (≥60 years, high dose, n=15). In each cohort, five sentinels were set up, and they were randomly vaccinated with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo in a 2:2:1 ratio. The remaining participants were randomly vaccinated in a 2:2:1 ratio with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo. For both sentinels and remaining participants, the investigational vaccine group and the control group (placebo) are enrolled parallelly.

Arm	Type	Receives
Low dose antigen of LYB005 without A01B adjuvant	Experimental	Biological: Low dose antigen of LYB005 without A01B adjuvantSubjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen without A01B adjuvant) at Day 0.
Low dose antigen of LYB005 with A01B adjuvant	Experimental	Biological: Low dose antigen of LYB005 with A01B adjuvantSubjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen with A01B adjuvant) at Day 0.
Middle dose antigen of LYB005 without A01B adjuvant	Experimental	Biological: Middle dose antigen of LYB005 without A01B adjuvantSubjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen without A01B adjuvant) at Day 0.
Middle dose antigen of LYB005 with A01B adjuvant	Experimental	Biological: Middle dose antigen of LYB005 with A01B adjuvantSubjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen with A01B adjuvant) at Day 0.
High dose antigen of LYB005 without A01B adjuvant	Experimental	Biological: High dose antigen of LYB005 without A01B adjuvantSubjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen without A01B adjuvant) at Day 0.
High dose antigen of LYB005 with A01B adjuvant	Experimental	Biological: High dose antigen of LYB005 with A01B adjuvantSubjects aged 18 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen with A01B adjuvant) at Day 0.
Placebo	Placebo comparator	Biological: PlaceboSubjects aged 18 years and older will be vaccinated with 1 dose of placebo at Day 0.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Residents aged 18 years and older (at the time of screening), regardless of gender;
Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form, and are able to attend all planned follow-up visits and comply with the protocol requirements;
Axillary temperature < 37.3°C on the day of enrollment;
Females of childbearing potential should use effective contraceptive measures one month before enrollment; females of childbearing potential (excluding those who have undergone tubal ligation, bilateral oophorectomy, or hysterectomy) and male participants should practice effective contraception and avoid pregnancy plans, as well as sperm or egg donation plans from the time of enrollment until 6 months after the full course of vaccination. Effective contraceptive methods include oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.

Key exclusion criteria (21 listed)

Allergy to the investigational vaccine or its excipients, or a history of anaphylactic shock or other serious adverse reactions to other vaccines;
Previous vaccination against Respiratory Syncytial Virus;
A confirmed diagnosis or etiological evidence of respiratory syncytial virus infection and related diseases caused by the infection within 12 months before enrollment;
Has taken antipyretics, analgesics or anti-allergy drugs within 24 hours before enrollment;
Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;

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
Low dose antigen of LYB005 without A01B adjuvant0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.	Biological	Low dose antigen of LYB005 without A01B adjuvant
Low dose antigen of LYB005 with A01B adjuvant0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.	Biological	Low dose antigen of LYB005 with A01B adjuvant
Middle dose antigen of LYB005 without A01B adjuvant0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.	Biological	Middle dose antigen of LYB005 without A01B adjuvant
Middle dose antigen of LYB005 with A01B adjuvant0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.	Biological	Middle dose antigen of LYB005 with A01B adjuvant
High dose antigen of LYB005 without A01B adjuvant0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.	Biological	High dose antigen of LYB005 without A01B adjuvant
High dose antigen of LYB005 with A01B adjuvant0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.	Biological	High dose antigen of LYB005 with A01B adjuvant
Placebo0.5 mL 0.9% sodium chloride (normal saline) injection per dose	Biological	Placebo

Primary outcome

Occurrence of immediate adverse events
Time frame: Within 30 minutes after vaccination
The incidence and severity of any adverse events (AEs) within 30 minutes after vaccination
Incidence of solicited AE
Time frame: Within 0-7 days after vaccination
Occurrence and severity of solicited local injection site reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., pain, redness, swelling). Occurrence and severity of solicited systemic reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., myalgia, fatigue, headache, chills, fever).
Incidence of unsolicited AEs
Time frame: Within 28 days after vaccination
The incidence and severity of any unsolicited AEs, including all AEs, except solicited AEs reported Days 0~28 after the vaccination.
Incidence of clinically significant abnormalities in clinical laboratory tests
Time frame: 3 days after vaccination
The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, coagulation function, and urinalysis) on Day 3 after vaccination.
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Time frame: 12 months after vaccination
The incidence of any SAEs and AESIs from the first vaccination up to 12 months after vaccination.

4 secondary outcomes

The geometric mean titer (GMT) of Neutralizing Antibodies Against RSV A and RSV B
Time frame: 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B
Time frame: 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
The geometric mean concentration (GMC) for Pre-fusion Protein Specific Binding Antibodies
Time frame: 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Number of Pre-fusion Protein Specific Interferon-gamma and Interleukin-4 spot-forming cells
Time frame: 28 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 22 Aug 2025.
Individual participant dataSharing planned: No

Related trials for Respiratory Syncytial Virus Infection

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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.

Beifang Yang principal investigator

Hubei Provincial 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?

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 21 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 22 Aug 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 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?

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?

Occurrence of immediate adverse events (time frame: Within 30 minutes after vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06904222.

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 22 Aug 2025.