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New mRNA vaccine targets RSV in early human trial
NCT ID NCT07289503
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new mRNA vaccine called ABO1105 against respiratory syncytial virus (RSV). Around 96 healthy adults aged 18 and older will receive either the vaccine or a placebo. The main goal is to check if the vaccine is safe and triggers an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ABO1105 (mRNA vaccine)
- What this could lead to
- If successful, this could lead to a safe and effective vaccine against RSV, a common respiratory virus.
- What could go wrong
- This is an early Phase 1 trial with only 96 participants, so safety and immune response are still unproven. The vaccine may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
96 people
The number who actually took part.
- Started
-
May 2025
- Expected to finish
-
Jun 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee and agree to participate in the trial before undergoing any trial procedures. 2. Healthy adults ≥18 years of age, participants with underlying diseases that are stably controlled may be accepted. 3. 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. 4. Male participants (and their female partners) and female participants of childbearing potential agree to continue effective contraception through 3 months following vaccination. Exclusion Criteria: 1. Presence of one or more respiratory symptoms within 7 days prior to vaccination, lasting for at least 24 hours. 2. 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. 3. Laboratory-confirmed history of RSV infection within the past 12 months, or previous vaccination with a respiratory syncytial virus vaccine. 4. 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 * Body mass index (BMI) ≤18 kg/m² or ≥30 kg/m² 5. .Clinically significant abnormalities of laboratory indicators or 12-lead ECG during the screening period. 6. Female participants known to be pregnant or breastfeeding, or positive pregnancy test for women of childbearing potential. 7. History of allergy to the investigational products or its excipients, or severe allergic reactions to other vaccines, foods, or medications. 8. 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. 9. Current participation in another clinical trial within 30 days prior to vaccination or planned participation before the end of this trial. 10. Clinician-diagnosed coagulation abnormalities. 11. Known medical history or diagnosis confirming the subject has a condition affecting immune system function. 12. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any condition that may increase the risk of myocarditis or pericarditis. 13. 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. 14. 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. 15. 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. 16. 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. 17. Treatment with immunoglobulins and/or blood products or blood donation through 3 months prior to and 3 months after vaccination in this trial. 18. Suspected or known alcohol dependence or drug abuse, which may affect safety assessment or trial compliance. 19. Planned long-term or permanent relocation away from the trial site area before trial completion. 20. Investigators, sponsors, and contract research organization (CRO) staff directly involved in the trial. 21. Other circumstances deemed unsuitable for trial participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baise Center For Disease Control & Prevention
Baise City, Baise, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One shot, two viruses: vaccine aims to shield older adults from RSV and HMPV
- Can an mRNA vaccine shield the most vulnerable from RSV?
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- Could a vaccine given during pregnancy shield infants from a deadly virus?
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