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Active Comparator hepatitis B vaccine
A hepatitis B vaccine that stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen.
A hepatitis B vaccine that stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen. Used for Prevention of hepatitis B infection.
At a glance
| Generic name | Active Comparator hepatitis B vaccine |
|---|---|
| Sponsor | Jiangsu Province Centers for Disease Control and Prevention |
| Drug class | vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Hepatitis B vaccines work by presenting hepatitis B surface antigen (HBsAg) to the immune system, triggering both humoral (antibody) and cell-mediated immune responses. This primes the body to recognize and neutralize hepatitis B virus upon exposure, preventing infection and chronic disease. The vaccine formulation from Jiangsu CDC likely contains recombinant HBsAg or similar immunogenic components.
Approved indications
- Prevention of hepatitis B infection
Common side effects
- Injection site pain or swelling
- Fever
- Fatigue
- Headache
Key clinical trials
- Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir (PHASE4)
- Hepatitis B Vaccine Delivered Trans-dermally by MAP (PHASE1)
- Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali (PHASE1)
- Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic Hepatitis B (PHASE1)
- A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection (PHASE1)
- Lot-to-lot Consistency of Sci-B-Vac™ in Adults (PHASE3)
- A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults (PHASE1)
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |