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Phase II clinical trial of different immune programs of recombinant hepatitis B vaccine (Hansonyeasts, CpG, and aluminum adjuvant)

A randomized, double-blind, position-controlled Phase II clinical trial to evaluate the immunogenicity and safety of recombinant hepatitis B vaccine (Hansonyeasts, CpG, and aluminum adjuvant) in people aged 18 years and older with different immunization schedules

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108408
Enrollment
Unknown
Registered
2025-08-29
Start date
2024-10-19
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Viral hepatitis B

Interventions

CpG adjuvant low dose group:Experimental vaccine
Positive control group:hepatitis B vaccine
CpG adjuvant high dose group:Experimental vaccine

Sponsors

Shandong Center for Disease Prevention and Control
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Be 18 years of age and above on the day of enrollment and can provide legal identification, voluntarily participate and agree to sign the informed consent; 2.The patient passed the physical examination, and was able to participate in regular visits according to the requirements of the experiment, without vaccination contraindications.

Exclusion criteria

Exclusion criteria: 1.History of viral hepatitis B; 2.Users who have received immunoglobulin, blood or blood-related products within 3 months prior to vaccination or during planned trials; 3.Have used another investigational or unregistered product (drug or vaccine) in the 3 months prior to vaccination, or are participating in or plan to participate in another clinical trial; 4.Receive any vaccines within 14 days prior to vaccination; 5.Acute febrile illness or acute infectious disease within 3 days prior to vaccination, or use of antipyretic, analgesic or anti-allergic drugs 3 days prior to vaccination; 6.Urine pregnancy test positive, pregnant, breastfeeding, or within 1 year of planning to have a child (for women of childbearing age); 7.Any other conditions that the investigator believes may affect the evaluation of the trial.

Design outcomes

Primary

MeasureTime frame
Positive conversion rate of anti-HBS antibody;Positive rate of anti-HBS antibody;

Countries

China

Contacts

Public ContactLi Zhang

Shandong Center for Disease Prevention and Control

Zl9127@163.com+86 531 82679693

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026