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LC16m8
LC16m8 is a live attenuated vaccinia virus vaccine designed to provide immunization against smallpox and monkeypox through viral replication and immune stimulation.
LC16m8 is a live attenuated vaccinia virus vaccine designed to provide immunization against smallpox and monkeypox through viral replication and immune stimulation. Used for Smallpox prevention, Monkeypox prevention.
At a glance
| Generic name | LC16m8 |
|---|---|
| Sponsor | International Vaccine Institute |
| Drug class | Live attenuated viral vaccine |
| Target | Orthopoxvirus antigens (smallpox virus, monkeypox virus) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
LC16m8 is a modified vaccinia virus Ankara (MVA)-derived vaccine candidate that replicates in mammalian cells to trigger both humoral and cellular immune responses against orthopoxviruses. The vaccine strain was derived from the LC16 vaccine lineage, which has a history of clinical use in Japan. It is intended to provide protection against smallpox and monkeypox through induction of neutralizing antibodies and T-cell mediated immunity.
Approved indications
- Smallpox prevention
- Monkeypox prevention
Common side effects
- Injection site reactions (erythema, induration, pain)
- Fever
- Myalgia
- Fatigue
Key clinical trials
- Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
- Efficacy/Effectiveness, Safety, and Immunogenicity of LC16m8 Mpox Vaccine in Colombia (PHASE3)
- Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers (PHASE1, PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LC16m8 CI brief — competitive landscape report
- LC16m8 updates RSS · CI watch RSS
- International Vaccine Institute portfolio CI