Y. Kim,1 D. Shin,1 S. Lee,1 J. Oh,1 J. Han,2 N. Lee,2 H. Lee,1 K. Yu,1 J. Chung,1 I. Jang1; 1Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital, Seoul, Korea, Republic of, 2Department of Bioscience & Biotechnology, Sejong University, Seoul, Korea, Republic of
BACKGROUND: EG-HPV is a novel human papilloma virus (HPV)-16/18 vaccine for prevention of cervical cancer containing CIA06 as an immunopotentiating adjuvant. The study aimed to evaluate the tolerability and immunogenicity of EG-HPV in healthy Korean male volunteers.
METHODS: A randomized, double-blind, placebo-controlled study was performed in 23 subjects, who randomly received intramuscular injection of EG-HPV with 10 or 50 µg of CIA06 (EG-HPV-10 and -50; N=8, respectively) or 10 µg CIA06 as placebo (N=7) at 0, 1 and 6 month. Anti-HPV 16/18 antibodies and their neutralizing antibodies were measured at 1 month after second and third vaccination (month 2 and month 7) by enzyme-linked immunosorbent assay. Tolerability profiles were evaluated based on vital signs, adverse events (AEs), clinical laboratory tests and electrocardiography.
RESULTS: The geometric mean titer (GMT) of initially seronegative subjects in the test groups for anti-HPV16/18 antibodies of EG-HPV-10 and -50 were: 1804; 2126 / 3440; 5411 IU/mL at month 2, 925; 1022 / 1514; 2806 EU/mL at month 7, respectively. The GMT of virus-neutralizing anti-HPV16/18 antibodies were: 6174; 7696 / 1601; 1806 IU/mL at month 2, 22868; 42882 / 6610; 9857 titre at month 7, respectively. No statistical differences in the antibody levels were observed between EG-HPV-10 and -50 groups at each time point. There were no statistically significant differences in solicited and unsolicited AE occurrence frequencies between the test and placebo groups (P > 0.05). Observed AEs were transient with mild or moderate severity and safety variables were not clinically significant.
CONCLUSION: EG-HPV vaccine was generally well tolerated in healthy subjects with increasing seroconversion levels after each vaccination, in terms of immunogenicity.