Post-Marketing Surveillance Study of Hepatitis A Vaccine in Korean Population

최재원,김명석,마상혁,강진한,옥진주,Hans L. Bock,Timothy L. Ng 대한소아감염학회 2008 Pediatric Infection and Vaccine Vol.15 No.2

Purpose : This post-marketing surveillance (PMS) study was conducted in Korea to assess the safety and reactogenicity of hepatitis A vaccine (GlaxoSmithKlineBiologicals'HavrixTM) administered to the Korean population. Methods : A total of 1,188 healthy subjects with 1,122 subjects <6 years of age were enrolled to receive one dose of the hepatitis A vaccine from April 2005 to January 2006. Diary cards were provided to the subjects or subjects' parents for reporting solicited and unsolicited symptoms during the 4-day and 31-day post-vaccination follow-up period. Results : The number of subjects who returned diary cards was 568, whereas, 620 subjects did not return diary cards. Among the subjects who returned diary cards, 9.9% and 14.3% reported local and general solicited/unsolicited symptoms. Among the subjects who did not return diary cards, 1.6% and 8.4% reported local and general solicited/unsolicited symptoms. At least one unsolicited symptom was reported by 13.2% of the subjects. Conclusion : Results indicate that the vaccine was well-tolerated and had an acceptable safety profile. The use of diary cards in such a survey provided a prompt and reliable option for recording symptoms. (Korean J Pediatr Infect Dis 2008;15:115-120) Purpose : This post-marketing surveillance (PMS) study was conducted in Korea to assess the safety and reactogenicity of hepatitis A vaccine (GlaxoSmithKlineBiologicals'HavrixTM) administered to the Korean population. Methods : A total of 1,188 healthy subjects with 1,122 subjects <6 years of age were enrolled to receive one dose of the hepatitis A vaccine from April 2005 to January 2006. Diary cards were provided to the subjects or subjects' parents for reporting solicited and unsolicited symptoms during the 4-day and 31-day post-vaccination follow-up period. Results : The number of subjects who returned diary cards was 568, whereas, 620 subjects did not return diary cards. Among the subjects who returned diary cards, 9.9% and 14.3% reported local and general solicited/unsolicited symptoms. Among the subjects who did not return diary cards, 1.6% and 8.4% reported local and general solicited/unsolicited symptoms. At least one unsolicited symptom was reported by 13.2% of the subjects. Conclusion : Results indicate that the vaccine was well-tolerated and had an acceptable safety profile. The use of diary cards in such a survey provided a prompt and reliable option for recording symptoms. (Korean J Pediatr Infect Dis 2008;15:115-120)

Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in 15-25 years old healthy Korean women

김승철,송용상,김영태,김영탁,류기성,Bhavyashree Gunapalaiah,Dan Bi,Hans L Bock,박종섭 대한부인종양학회 2011 Journal of Gynecologic Oncology Vol.22 No.2

Objective: The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years. Methods: Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adjuvanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3. Serum samples were collected pre-vaccination and one month post-dose 3. Safety and reactogenicity data were collected throughout. Results: In this trial, 208 women completed the study (141 in HPV group; 67 in placebo group). At month 7, all initially seronegative women had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titres of 9,351.4 El.U/mL (95% CI, 8,145.5 to 10,735.8) and 4204.1 El.U/mL (95% CI, 3,626.5 to 4,873.6), respectively. Initially seropositive women showed similar increase in geometric mean titre levels. Compliance to the three dose vaccination course was 95.3% in HPV and 89.5% in placebo group. Solicited local (pain) and general (fatigue, myalgia or headache) symptoms were commonly reported in both groups. Three serious adverse events were reported (two in HPV group; one in placebo group), all unrelated to vaccination by the investigator; all recovered. Conclusion: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic with a clinically acceptable safety profile in Korean women. This study was in line with previous global studies in Europe, North America, and Brazil. (ClinicalTrials.gov number, NCT 00485732.) Objective: The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years. Methods: Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adjuvanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3. Serum samples were collected pre-vaccination and one month post-dose 3. Safety and reactogenicity data were collected throughout. Results: In this trial, 208 women completed the study (141 in HPV group; 67 in placebo group). At month 7, all initially seronegative women had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titres of 9,351.4 El.U/mL (95% CI, 8,145.5 to 10,735.8) and 4204.1 El.U/mL (95% CI, 3,626.5 to 4,873.6), respectively. Initially seropositive women showed similar increase in geometric mean titre levels. Compliance to the three dose vaccination course was 95.3% in HPV and 89.5% in placebo group. Solicited local (pain) and general (fatigue, myalgia or headache) symptoms were commonly reported in both groups. Three serious adverse events were reported (two in HPV group; one in placebo group), all unrelated to vaccination by the investigator; all recovered. Conclusion: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic with a clinically acceptable safety profile in Korean women. This study was in line with previous global studies in Europe, North America, and Brazil. (ClinicalTrials.gov number, NCT 00485732.)

Erratum

김용재,김경태,김재훈,차순도,김재원,배덕수,남주현,안웅식,최호선,Timothy Ng,Dan Bi,옥진주,Dominique Descamps,Hans L Bock 대한의학회 2010 Journal of Korean medical science Vol.25 No.12

Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in 15-25 years old healthy Korean women

Kim, Seung Cheol,Song, Yong Sang,Kim, Young-Tae,Kim, Young Tak,Ryu, Ki-Sung,Gunapalaiah, Bhavyashree,Bi, Dan,Bock, Hans L,Park, Jong-Sup Korean Society of Gynecologic Oncology and Colposc 2011 Journal of Gynecologic Oncology Vol.22 No.2

<P><B>Objective</B></P><P>The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years.</P><P><B>Methods</B></P><P>Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adjuvanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3. Serum samples were collected pre-vaccination and one month post-dose 3. Safety and reactogenicity data were collected throughout.</P><P><B>Results</B></P><P>In this trial, 208 women completed the study (141 in HPV group; 67 in placebo group). At month 7, all initially seronegative women had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titres of 9,351.4 El.U/mL (95% CI, 8,145.5 to 10,735.8) and 4204.1 El.U/mL (95% CI, 3,626.5 to 4,873.6), respectively. Initially seropositive women showed similar increase in geometric mean titre levels. Compliance to the three dose vaccination course was 95.3% in HPV and 89.5% in placebo group. Solicited local (pain) and general (fatigue, myalgia or headache) symptoms were commonly reported in both groups. Three serious adverse events were reported (two in HPV group; one in placebo group), all unrelated to vaccination by the investigator; all recovered.</P><P><B>Conclusion</B></P><P>The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic with a clinically acceptable safety profile in Korean women. This study was in line with previous global studies in Europe, North America, and Brazil. (ClinicalTrials.gov number, NCT 00485732.)</P>

Human Papillomavirus (HPV) Type Distribution in Korean Women: a Meta-Analysis

( Jeong Hoon Bae ),( Sung Jong Lee ),( Cjan Joo Kim ),( Soo Young Hur ),( Yong Gyu Park ),( Won Chul Lee ),( Young Tak Kim ),( Timothy L. Ng ),( Hans L. Bock ),( Jong Sup Park ) 한국미생물 · 생명공학회 2008 Journal of microbiology and biotechnology Vol.18 No.4