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Clinical Study on Engineering Multivalent Antigen Particles to Activate Oral Mucosal Immunity

Clinical Study on Engineering Multivalent Antigen Particles to Activate Oral Mucosal Immunity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114165
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-10
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral mucosal immunity

Interventions

EXperimental group:Temporary engineered multiantigen particle based sublingual tablet for the sublingual mucosal area intervention

Sponsors

The Affiliated Hospital of Stomatology, Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Volunteers recruited clinically, aged 20-50, with no gender restrictions. 2. Subjects voluntarily sign an informed consent form, with expected good compliance.

Exclusion criteria

Exclusion criteria: 1. Individuals who have previously undergone oral surgery or have dental restorations that may interfere with the evaluation of the study parameters. 2. Hypertensive patients with a systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg. 3. Patients with systemic diseases (autoimmune diseases, malignant tumors, diabetes, heart failure due to cardiac disease, myocardial infarction within the last 6 months, angina symptoms within the last 6 months, congenital heart disease, etc.). 4. Individuals currently using nonsteroidal anti-inflammatory drugs (NSAIDs), bisphosphonates, or corticosteroids. 5. Individuals with bleeding tendency or coagulation dysfunction (white blood cell count WBC<3.0 * 10 ^ 9/L or platelet count PLT<60 * 10 ^ 9/L); 6. HIV or hepatitis B virus carriers. 7. Pregnant or breastfeeding women, or women planning to become pregnant within 6 months or using estrogen-based contraception. 8. Patients with a history of alcohol abuse, intravenous drug addiction, mental disorders or intellectual disabilities, etc.

Design outcomes

Primary

MeasureTime frame
Vital signs, including body temperature, blood pressure and heart rate;Oral mucosal examination;Complete blood count and blood biochemical parameters;Adverse events considered related to administration of engineered multiantigen particle based sublingual tablet;

Secondary

MeasureTime frame
S. aureus-specific salivary sIgA level;Submandibular lymph-node ultrasound examination;

Countries

China

Contacts

Public ContactXu Junji

The Affiliated Hospital of Stomatology, Chongqing Medical University

jjxu0713@hotmail.com+86 138 1118 4713

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026