J Gynecol Oncol.  2011 Jun;22(2):67-75. 10.3802/jgo.2011.22.2.67.

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

• Kim SC
• Song YS
• Kim YT
• Kim YT
• Ryu KS
• Gunapalaiah B
• Bi D
• Bock HL
• Park JS

• KMID: 2288569
• DOI: http://doi.org/10.3802/jgo.2011.22.2.67

Abstract

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.)

Keyword

AS04-adjuvanted; Cervical cancer; Geometric mean titres; Human papillomavirus-16/18; Immunogenicity; Seroconversion

MeSH Terms

Aged
Antibodies
Brazil
Compliance
Europe
Female
Human papillomavirus 16
Human papillomavirus 18
Humans
Korea
North America
Uterine Cervical Neoplasms
Vaccination
Antibodies

Figure

• 

  Fig. 1 Study participants flowchart. N, total number of subjects; n, number of subjects with elimination code assigned excluding ones who have been assigned a lower elimination code number.

• 

  Fig. 2 Solicited local symptoms (overall/dose) with 95% confidence interval during the 7-day post-vaccination period (total vaccinated cohort). HPV group: N=429, ALU group: N=210.

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  Fig. 3 Solicited general symptoms reported overall/dose during the 7-day post-vaccination period (total vaccinated cohort). HPV group: N=429, ALU group: N=210.

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