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mRNA-1283
mRNA-1283 is a self-amplifying mRNA vaccine that encodes human papillomavirus (HPV) antigens to stimulate immune responses against HPV-infected cells.
mRNA-1283 is a self-amplifying mRNA vaccine that encodes human papillomavirus (HPV) antigens to stimulate immune responses against HPV-infected cells. Used for HPV16/18-positive cervical cancer (in combination with Merck's Keytruda), HPV-related cancers and precancerous lesions.
At a glance
| Generic name | mRNA-1283 |
|---|---|
| Sponsor | ModernaTX, Inc. |
| Drug class | mRNA vaccine |
| Target | HPV16 and HPV18 antigens (E6 and E7 proteins) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
The vaccine delivers self-amplifying mRNA (saRNA) that is translated into HPV16 and HPV18 antigens within host cells, triggering both CD8+ T-cell and antibody responses. This approach aims to treat existing HPV-related cancers and precancerous lesions by mobilizing the patient's own immune system to recognize and eliminate HPV-expressing cells.
Approved indications
- HPV16/18-positive cervical cancer (in combination with Merck's Keytruda)
- HPV-related cancers and precancerous lesions
Common side effects
- Injection site reactions
- Fatigue
- Myalgia
- Fever
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19) (PHASE4)
- COVID-19 Reactogenicity (PHASE4)
- A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations (PHASE4)
- A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters (PHASE2)
- A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (PHASE3)
- A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19 (PHASE1)
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:
- mRNA-1283 CI brief — competitive landscape report
- mRNA-1283 updates RSS · CI watch RSS
- ModernaTX, Inc. portfolio CI