Phase II Clinical Trial of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 50 Years or Above

NCT07289542 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ABO1105-201
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the immunogenicity and safety of a single injection of two dose levels of ABO1105 in adults aged 50 years or above.

Conditions

Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibodies (Abs)

  Up to Day 30

• Geometric Mean Increase versus Postbaseline/Baseline Ab Titers

  Up to Day 30

Study Arms (3)

Group 1: Dose level A in adults aged 50 years or above

EXPERIMENTAL

Single injection of Dose level A of ABO1105

Biological: ABO1105

Group 2: Dose level B in adults aged 50 years or above

EXPERIMENTAL

Single injection of Dose level B of ABO1105

Biological: ABO1105

Group 3: Placebo control in adults aged 50 years or above

PLACEBO COMPARATOR

Single injection of placebo on Day 0

Drug: Placebo

Interventions

Placebo DRUG

0.9% sodium chloride (normal saline) injection

Group 3: Placebo control in adults aged 50 years or above

ABO1105 BIOLOGICAL

Formulation for injection

Group 1: Dose level A in adults aged 50 years or above; Group 2: Dose level B in adults aged 50 years or above

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥50 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.

You may not qualify if:

• Presence of one or more respiratory symptoms within 7 days prior to vaccination, lasting for at least 24 hours.
• Acute illness or fever 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, participants with resting pulse between 100 to 110 without significant symptoms, such as palpitations, chest tightness, dizziness and fatigue, will be accepted.
• Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg for participants aged 50-59, or systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg for participants aged ≥60
• Body mass index (BMI) ≥30 kg/m²
• Female participants known to be pregnant or breastfeeding, or positive pregnancy test for women of childbearing potential.
• History of allergy to any ingredients of the investigational products, 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.

Sponsors & Collaborators

• Suzhou Abogen Biosciences Co., Ltd.: lead
• Abogen Biosciences (Shanghai) Co., Ltd: collaborator

Study Sites (1)

Baise Center For Disease Control & Prevention

Baise City, Baise, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: September 15, 2025
• Primary Completion: January 7, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)