End stage cervical cancer patients

Three groups of end stage cervical cancer patients (in total N=35) were subcutaneously vaccinated with HPV16 E6 combined with or separated from HPV16 E7 overlapping long peptides in Montanide ISA-51 adjuvant, 4 times at three week intervals. Group 1 received 300 microgram per peptide at a single site, group 2 received 100 microgram per peptide of the E6 peptides in one limb, and 300 microgram per peptide of the E7 peptides in a second limb. Group 3 received separate injections of E6 and E7 peptides, each at a dose of 50 micrograms per peptide. The primary endpoint was to determine safety and toxicity of the HPV16 long peptide vaccine. In addition, the vaccine-induced T-cell response was assessed by IFN gamma-ELISPOT. No toxicity beyond grade II was observed during and after 4 vaccinations. In a few patients transient flu-like symptoms were observed. ELISPOT analysis of the vaccine-induced immune response revealed that co-injection of the E6 and E7 peptides resulted in a strong and broad T-cell response dominated by immunity against E6. Injection of the E6 and E7 peptides at two different sites increased the E7-response but did not affect the magnitude of the E6-induced immune response.

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