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IC51
IC51 is a therapeutic vaccine that stimulates the immune system to recognize and attack cells infected with human papillomavirus (HPV).
IC51 is a therapeutic vaccine that stimulates the immune system to recognize and attack cells infected with human papillomavirus (HPV). Used for Cervical intraepithelial neoplasia (CIN) 2/3 associated with HPV infection.
At a glance
| Generic name | IC51 |
|---|---|
| Also known as | Japanese Encephalitis purified inactivated vaccine, Japanese Encephalitis vaccine |
| Sponsor | Valneva Austria GmbH |
| Drug class | Therapeutic vaccine |
| Target | Human papillomavirus (HPV) antigens |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | Phase 3 |
Mechanism of action
IC51 is a recombinant HPV vaccine candidate designed to provide therapeutic benefit in patients with existing HPV-related disease, particularly cervical intraepithelial neoplasia (CIN). Unlike prophylactic HPV vaccines, IC51 aims to generate cellular and humoral immune responses against HPV-infected cells to promote clearance of infection and regression of precancerous lesions.
Approved indications
- Cervical intraepithelial neoplasia (CIN) 2/3 associated with HPV infection
Common side effects
- Injection site reactions
- Fever
- Myalgia
- Fatigue
Key clinical trials
- Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51 (PHASE3)
- Safety and Tolerability of the Japanese Encephalitis Vaccine IC51 (PHASE3)
- Immunogenicity Study of the Japanese Encephalitis Vaccine IC51 (PHASE3)
- Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population (PHASE3)
- Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries (PHASE3)
- Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study (PHASE3)
- Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling (PHASE3)
- Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country (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 |