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Vaccine Detail
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MUC1 105mer Peptide/BCG Vaccine |
| Vaccine Information |
- Vaccine Name: MUC1 105mer Peptide/BCG Vaccine
- Target Pathogen: Cancer
- Target Disease: Cancer
- Type: Peptide vaccine
- Status: Clinical trial
- Host Species for Licensed Use: Human
- Antigen: 105-mer MUC1 (Goydos et al., 1996)
- Immunization Route: Intradermal injection (i.d.)
- Description: A 105 amino acid synthetic MUC1 peptide vaccine comprising five tandemly repeated immunodominant epitopes of the MUC1 polypeptide core, admixed with BCG, administered intradermally at 100 µg to 63 patients with adenocarcinomas of the pancreas (n=24), colorectal (n=30), and breast (n=9) in three vaccinations at 3-week intervals. The peptide represents the conserved tandem repeat of the MUC1 core protein, hypoglycosylated and nonpolarized on tumor cells, exposing epitopes capable of stimulating CTL responses. DTH testing used three formulations: 8 immunodominant nonameric sequences, 7 control nonameric sequences lacking the immunodominant epitope, and the full 105aa polypeptide, injected intradermally at 1, 10, and 100 µg. All patients tolerated vaccination; skin breakdown occurred in 98%, with fever (64%), chills (48%), night sweats (43%), anorexia (40%), rigors (16%), nausea (9%), hypoalbuminemia (40%), and hypercalcemia (24%). The 105aa multivalent peptide showed greater immunogenicity than shorter nonameric sequences due to multivalent epitope presentation. Biopsy of 55 DTH sites revealed intense CD3+ T-cell infiltration in 37 patients and lesser infiltration in 7, predominantly at 105aa peptide sites; only 3 patients mounted a strong cutaneous DTH response at the 100 µg site. Of 22 patients tested, 7 (32%) showed a 2- to 4-fold increase in mucin-specific CTLp, demonstrating boostable mucin-specific immunity. Serum IL-6 correlated with symptom severity (r=0.63, p=0.001) and hypoalbuminemia (r=−0.34, p=0.007). Three patients achieved disease stabilization (2 colorectal, 1 pancreatic); no partial or complete responses were observed and no clinical efficacy was demonstrated. Two patients died from progressive disease during the trial (Goydos et al., 1996).
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| References |
Goydos et al., 1996: Goydos JS, Elder E, Whiteside TL, Finn OJ, Lotze MT. A phase I trial of a synthetic mucin peptide vaccine. Induction of specific immune reactivity in patients with adenocarcinoma. The Journal of surgical research. 1996; 63(1); 298-304. [PubMed: 8667619].
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