Respiratory Syncytial VirusPhase 1NCT07289503
Phase I Clinical Trial of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 18 Years or Above
A Phase 1 study testing ABO1105 in people with Respiratory Syncytial Virus, run by Suzhou Abogen Biosciences Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the tolerability, reactogenicity and safety of a single injection of three dose levels of ABO1105 in adults aged 18 years or above. 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
- What is being tested?
- ABO1105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2025to 27 Jun 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
- Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee and agree to participate in the trial before undergoing any trial procedures.
- Healthy adults ≥18 years of age, participants with underlying diseases that are stably controlled may be accepted.
- Willing to and physically able to communicate with the investigators, understand and comply with protocol required follow-up, simple self-observation and recording using the Diary Card.
- Male participants (and their female partners) and female participants of childbearing potential agree to continue effective contraception through 3 months following vaccination.
Who cannot join
- Presence of one or more respiratory symptoms within 7 days prior to vaccination, lasting for at least 24 hours.
- Acute illness or fever on the day of vaccination or within 3 days prior to vaccination, or use of anti-inflammatory, anti-allergy, antibiotic, or antiviral medications due to physical discomfort.
- Laboratory-confirmed history of RSV infection within the past 12 months, or previous vaccination with a respiratory syncytial virus vaccine.
- Clinically significant abnormal vital signs, including but not limited to:
- Resting pulse rate <50 beats per minute or >100 beats per minute
- Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg for participants aged 18-59, or systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg for participants aged ≥60
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- Body mass index (BMI) ≤18 kg/m² or ≥30 kg/m²
- .Clinically significant abnormalities of laboratory indicators or 12-lead ECG during the screening period.
- Female participants known to be pregnant or breastfeeding, or positive pregnancy test for women of childbearing potential.
- History of allergy to the investigational products or its excipients, or severe allergic reactions to other vaccines, foods, or medications.
- Use or planned use of any vaccine other than the investigational products through 30 days prior to and 30 days after vaccination in this trial.
- Current participation in another clinical trial within 30 days prior to vaccination or planned participation before the end of this trial.
- Clinician-diagnosed coagulation abnormalities.
- Known medical history or diagnosis confirming the subject has a condition affecting immune system function.
- History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any condition that may increase the risk of myocarditis or pericarditis.
- Severe or uncontrolled respiratory, cardiovascular, neurological, hematological, lymphatic, hepatic, renal, metabolic, or skeletal diseases; known severe congenital malformations; developmental disorders; or clinically diagnosed severe chronic conditions that may affect trial outcomes.
- Current infectious period of any communicable disease, acute infection, or acute phase of chronic infection, or ongoing anti-tuberculosis treatment; or prior positive test for hepatitis B surface antigen, hepatitis C virus antibody, or Treponema pallidum antibody.
- Past or current diagnosis of neurological or psychiatric disorders, or family history of neurological/psychiatric disorders; or other neurological conditions deemed unsuitable for trial participation by the investigator.
- Long-term use of immunosuppressants or immunomodulators within 6 months prior to vaccination, excluding topical medications. Topical medications should not exceed recommended doses or induce systemic exposure.
- Treatment with immunoglobulins and/or blood products or blood donation through 3 months prior to and 3 months after vaccination in this trial.
- Suspected or known alcohol dependence or drug abuse, which may affect safety assessment or trial compliance.
- Planned long-term or permanent relocation away from the trial site area before trial completion.
- Investigators, sponsors, and contract research organization (CRO) staff directly involved in the trial.
- Other circumstances deemed unsuitable for trial participation by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded and Placebo-Control Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 18 Years or Above
The primary objective of this study is to evaluate the tolerability, reactogenicity and safety of a single injection of three dose levels of ABO1105 in adults aged 18 years or above.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- ABO1105, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO1105Biological
Formulation for injection
PlaceboDrug
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose level A in adults aged 18 years or above | Other | Single injection of Dose level A of ABO1105 Receives: Biological: ABO1105; Drug: Placebo |
| Cohort 2: Dose level B in adults aged 18 years or above | Other | Single injection of Dose level B of ABO1105 Receives: Biological: ABO1105; Drug: Placebo |
| Cohort 3: Dose level C in adults aged 18 years or above | Other | Single injection of Dose level C of ABO1105 Receives: Biological: ABO1105; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited AEs and ARs after a single dose
Measured: up to Day 14
Incidence of unsolicited AEs and ARs after a single dose
Measured: up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start27 May 2025
- Primary completion4 Sep 2025
- Study completion27 Jun 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 VirusStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abogen Biosciences (Shanghai) Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289503
- Sponsor's protocol ID
- ABO1105-101
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded and Placebo-Control Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 18 Years or Above
- ClinicalTrials.gov ID
- NCT07289503
- Acronym / sponsor ID
- ABO1105-101
- Conditions
- Respiratory Syncytial Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Abogen Biosciences (Shanghai) Co., Ltd
- Study start
- 27 May 2025 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 27 Jun 2026 (estimated)
- First posted
- 17 Dec 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.
The primary objective of this study is to evaluate the tolerability, reactogenicity and safety of a single injection of three dose levels of ABO1105 in adults aged 18 years or above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose level A in adults aged 18 years or above | Other | Biological: ABO1105, Drug: PlaceboSingle injection of Dose level A of ABO1105 |
| Cohort 2: Dose level B in adults aged 18 years or above | Other | Biological: ABO1105, Drug: PlaceboSingle injection of Dose level B of ABO1105 |
| Cohort 3: Dose level C in adults aged 18 years or above | Other | Biological: ABO1105, Drug: PlaceboSingle injection of Dose level C of ABO1105 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee and agree to participate in the trial before undergoing any trial procedures.
- Healthy adults ≥18 years of age, participants with underlying diseases that are stably controlled may be accepted.
- Willing to and physically able to communicate with the investigators, understand and comply with protocol required follow-up, simple self-observation and recording using the Diary Card.
- Male participants (and their female partners) and female participants of childbearing potential agree to continue effective contraception through 3 months following vaccination.
Key exclusion criteria (24 listed)
- Presence of one or more respiratory symptoms within 7 days prior to vaccination, lasting for at least 24 hours.
- Acute illness or fever on the day of vaccination or within 3 days prior to vaccination, or use of anti-inflammatory, anti-allergy, antibiotic, or antiviral medications due to physical discomfort.
- Laboratory-confirmed history of RSV infection within the past 12 months, or previous vaccination with a respiratory syncytial virus vaccine.
- Clinically significant abnormal vital signs, including but not limited to:
- .Clinically significant abnormalities of laboratory indicators or 12-lead ECG during the screening period.
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 |
|---|---|---|
| ABO1105Formulation for injection | Biological | Cohort 1: Dose level A in adults aged 18 years or above, Cohort 2: Dose level B in adults aged 18 years or above, Cohort 3: Dose level C in adults aged 18 years or above |
| Placebo0.9% sodium chloride (normal saline) injection | Drug | Cohort 1: Dose level A in adults aged 18 years or above, Cohort 2: Dose level B in adults aged 18 years or above, Cohort 3: Dose level C in adults aged 18 years or above |
Primary outcome
Incidence of solicited AEs and ARs after a single dose
Time frame: up to Day 14
Incidence of unsolicited AEs and ARs after a single dose
Time frame: up to Day 30
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 ABO1105 in people with Respiratory Syncytial Virus, run by Suzhou Abogen Biosciences 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 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 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. 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?
Incidence of solicited AEs and ARs after a single dose (time frame: up to Day 14). The study lists 2 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 17 Dec 2025.