Comparative overview of cancer vaccine modalities.
| Feature | Fully personalized | Semi-personalized | Off-the-shelf |
|---|---|---|---|
| Antigen source | Unique neoantigens from each patient’s tumor | Shared neoepitopes (e.g., hotspot mutations, public neoantigens) | Tumor-associated antigens (TAAs) are common across patients |
| HLA matching | Patient-specific HLA binding predictions | Designed for frequent HLA alleles (e.g., HLA-A*02:01) | Broad population, minimal HLA stratification |
| Manufacturing lead time | 6–12 weeks (custom synthesis, QC, formulation) | 1–3 weeks (batch-based pre-manufactured panels) | Immediate (pre-made and stocked) |
| Production scale | Individual (n = 1) | Small-to-medium batches matched to subgroups | Mass production possible |
| Cost per dose (estimated) | |||
| Regulatory pathway | Complex; often under IND or adaptive frameworks | More streamlined; batch-based approval possible | Conventional biologics license application (BLA) |
| Example technologies | mRNA vaccines tailored to private neoantigens | mRNA or peptide vaccines targeting KRAS G12D, TP53 R175H, etc. | PROSTVAC, NY-ESO-1, HPV E6/E7 vaccines |
| Clinical flexibility | Maximal specificity; can target unique mutanomes | Balances specificity and scalability | Low specificity; limited by immune tolerance |
| Turnaround from biopsy to dosing | ~8–12 weeks | ~2–3 weeks | 0 weeks |
| Challenges | High cost, time, and individualized QA/QC | HLA restrictions, partial personalization | Poor immunogenicity, immune tolerance |
HLA: human leukocyte antigen; HPV: human papillomavirus; mRNA: messenger ribonucleic acid.