Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 1014 years

Tino F. Schwarz, Li Min Huang, Doris Maribel Rivera Medina, Alejandra Valencia, Tzou Yien Lin, Ulrich Behre, Grgory Catteau, Florence Thomas, Dominique Descamps

Research output: Contribution to journalArticle

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Abstract

Purpose: Long-term immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine when administered to adolescent girls was evaluated. Methods: This open-label, follow-up study (NCT00316706) was conducted in 31 centers in Taiwan, Germany, Honduras, Panama, and Colombia. In the initial study (NCT00196924), 1,035 girls aged 1014 years received the HPV-16/18 AS04-adjuvanted vaccine at 0, 1, and 6 months. Here, geometric mean titers (GMTs) of antibodies against HPV-16, HPV-18, and monophosphoryl lipid A (MPL), a component of the AS04 Adjuvant System, were reported up to month 48. Results: In the according-to-protocol immunogenicity cohort (N = 563), GMTs at month 48 in initially seronegative participants were 2,374.9 (95% confidence interval: 2,205.72,557.0) EL.U/mL for anti-HPV-16 and 864.8 (796.9938.4) EL.U/mL for anti-HPV-18, that is, six- and threefold higher than the plateau level in a reference study demonstrating vaccine efficacy in young women (age, 1525 years). All participants remained seropositive for anti-HPV-16 and anti-HPV-18 at month 48. Most participants (81.8%) were seropositive for anti-MPL antibodies before vaccination. Anti-MPL antibody titers in initially seropositive participants increased initially, and then declined. Most initially seronegative participants for anti-MPL seroconverted; 69.6% remained seropositive at month 48, with anti-MPL antibody titers similar to the natural background level. The vaccine was generally well tolerated. No serious adverse events were considered related to vaccination. Conclusions: In adolescent girls, the HPV-16/18 AS04-adjuvanted vaccine produces anti-HPV-16 and anti-HPV-18 antibody titers that are maintained for up to 4 years at higher levels than those in young women in whom vaccine efficacy against cervical lesions was demonstrated.

Original languageEnglish
Pages (from-to)187-194
Number of pages8
JournalJournal of Adolescent Health
Volume50
Issue number2
DOIs
Publication statusPublished - Feb 2012
Externally publishedYes

Fingerprint

Human papillomavirus 18
Human papillomavirus 16
Vaccines
Safety
Antibodies
Vaccination
Honduras
Panama
Colombia
Taiwan
Germany
monophosphoryl lipid A
Confidence Intervals

Keywords

  • Adolescent
  • Cervical cancer
  • Female
  • HPV-16/18 AS04-adjuvanted vaccine
  • Human papillomavirus
  • Immunogenicity
  • Long-term
  • Monophosphoryl lipid A
  • Safety

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Public Health, Environmental and Occupational Health
  • Psychiatry and Mental health

Cite this

Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 1014 years. / Schwarz, Tino F.; Huang, Li Min; Medina, Doris Maribel Rivera; Valencia, Alejandra; Lin, Tzou Yien; Behre, Ulrich; Catteau, Grgory; Thomas, Florence; Descamps, Dominique.

In: Journal of Adolescent Health, Vol. 50, No. 2, 02.2012, p. 187-194.

Research output: Contribution to journalArticle

Schwarz, Tino F. ; Huang, Li Min ; Medina, Doris Maribel Rivera ; Valencia, Alejandra ; Lin, Tzou Yien ; Behre, Ulrich ; Catteau, Grgory ; Thomas, Florence ; Descamps, Dominique. / Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 1014 years. In: Journal of Adolescent Health. 2012 ; Vol. 50, No. 2. pp. 187-194.
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abstract = "Purpose: Long-term immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine when administered to adolescent girls was evaluated. Methods: This open-label, follow-up study (NCT00316706) was conducted in 31 centers in Taiwan, Germany, Honduras, Panama, and Colombia. In the initial study (NCT00196924), 1,035 girls aged 1014 years received the HPV-16/18 AS04-adjuvanted vaccine at 0, 1, and 6 months. Here, geometric mean titers (GMTs) of antibodies against HPV-16, HPV-18, and monophosphoryl lipid A (MPL), a component of the AS04 Adjuvant System, were reported up to month 48. Results: In the according-to-protocol immunogenicity cohort (N = 563), GMTs at month 48 in initially seronegative participants were 2,374.9 (95{\%} confidence interval: 2,205.72,557.0) EL.U/mL for anti-HPV-16 and 864.8 (796.9938.4) EL.U/mL for anti-HPV-18, that is, six- and threefold higher than the plateau level in a reference study demonstrating vaccine efficacy in young women (age, 1525 years). All participants remained seropositive for anti-HPV-16 and anti-HPV-18 at month 48. Most participants (81.8{\%}) were seropositive for anti-MPL antibodies before vaccination. Anti-MPL antibody titers in initially seropositive participants increased initially, and then declined. Most initially seronegative participants for anti-MPL seroconverted; 69.6{\%} remained seropositive at month 48, with anti-MPL antibody titers similar to the natural background level. The vaccine was generally well tolerated. No serious adverse events were considered related to vaccination. Conclusions: In adolescent girls, the HPV-16/18 AS04-adjuvanted vaccine produces anti-HPV-16 and anti-HPV-18 antibody titers that are maintained for up to 4 years at higher levels than those in young women in whom vaccine efficacy against cervical lesions was demonstrated.",
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AU - Medina, Doris Maribel Rivera

AU - Valencia, Alejandra

AU - Lin, Tzou Yien

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AU - Catteau, Grgory

AU - Thomas, Florence

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N2 - Purpose: Long-term immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine when administered to adolescent girls was evaluated. Methods: This open-label, follow-up study (NCT00316706) was conducted in 31 centers in Taiwan, Germany, Honduras, Panama, and Colombia. In the initial study (NCT00196924), 1,035 girls aged 1014 years received the HPV-16/18 AS04-adjuvanted vaccine at 0, 1, and 6 months. Here, geometric mean titers (GMTs) of antibodies against HPV-16, HPV-18, and monophosphoryl lipid A (MPL), a component of the AS04 Adjuvant System, were reported up to month 48. Results: In the according-to-protocol immunogenicity cohort (N = 563), GMTs at month 48 in initially seronegative participants were 2,374.9 (95% confidence interval: 2,205.72,557.0) EL.U/mL for anti-HPV-16 and 864.8 (796.9938.4) EL.U/mL for anti-HPV-18, that is, six- and threefold higher than the plateau level in a reference study demonstrating vaccine efficacy in young women (age, 1525 years). All participants remained seropositive for anti-HPV-16 and anti-HPV-18 at month 48. Most participants (81.8%) were seropositive for anti-MPL antibodies before vaccination. Anti-MPL antibody titers in initially seropositive participants increased initially, and then declined. Most initially seronegative participants for anti-MPL seroconverted; 69.6% remained seropositive at month 48, with anti-MPL antibody titers similar to the natural background level. The vaccine was generally well tolerated. No serious adverse events were considered related to vaccination. Conclusions: In adolescent girls, the HPV-16/18 AS04-adjuvanted vaccine produces anti-HPV-16 and anti-HPV-18 antibody titers that are maintained for up to 4 years at higher levels than those in young women in whom vaccine efficacy against cervical lesions was demonstrated.

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