Comparison of the immunogenicity and safety of Cervarix™ and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years

Mark H. Einstein, Mira Baron, Myron J. Levin, Archana Chatterjee, Robert P. Edwards, Fred Zepp, Isabelle Carletti, Francis J. Dessy, Andrew F. Trofa, Anne Schuind, Gary Dubin

Research output: Contribution to journalArticle

303 Citations (Scopus)

Abstract

This observer-blind study compared the prophylactic human papillomavirus (HPV) vaccines, Cervarix™ (GlaxoSmithKline) and Gardasil® (Merck), by assessing immunogenicity and safety through one month after completion of the three-dose vaccination course. Women (n = 1106) were stratified by age (18-26, 27-35, 36-45 years) and randomized (1:1) to receive Cervarix™ (Months 0, 1, 6) or Gardasil® (Months 0, 2, 6). At Month 7 after first vaccination, all women in the according-toprotocol cohort who were seronegative/DNA negative before vaccination for the HPV type analyzed had seroconverted for HPV-16 and HPV-18 serum neutralizing antibodies, as measured by pseudovirion-based neutralization assay (PBNA), except for two women aged 27-35 years in the Gardasil® group who did not seroconvert for HPV-18 (98%). Geometric mean titers of serum neutralizing antibodies ranged from 2.3-4.8-fold higher for HPV-16 and 6.8-9.1-fold higher for HPV-18 after vaccination with Cervarix™ compared with Gardasil®, across all age strata. In the total vaccinated cohort (all women who received at least one vaccine dose, regardless of their serological and DNA status prior to vaccination), Cervarix™ induced significantly higher serum neutralizing antibody titers in all age strata (p < 0.0001). Positivity rates for anti-HPV-16 and -18 neutralizing antibodies in cervicovaginal secretions and circulating HPV-16 and -18 specific memory B-cell frequencies were also higher after vaccination with Cervarix™ compared with Gardasil ®. Both vaccines were generally well tolerated. The incidence of unsolicited adverse events was comparable between vaccinated groups. The incidence of solicited symptoms was generally higher after Cervarix™, injection site reactions being most common. However, compliance rates with the three-dose schedules were similarly high (≥ 84%) for both vaccines. Although the importance of differences in magnitude of immune response between these vaccines is unknown, they may represent determinants of duration of protection against HPV-16/18. Long-term studies evaluating duration of efficacy after vaccination are needed for both vaccines.

Original languageEnglish (US)
Pages (from-to)705-719
Number of pages15
JournalHuman Vaccines
Volume5
Issue number10
DOIs
StatePublished - 2009

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Cancer Vaccines
Human papillomavirus 18
Uterine Cervical Neoplasms
Human papillomavirus 16
Vaccination
Safety
Neutralizing Antibodies
Vaccines
Serum
Papillomavirus Vaccines
DNA
Incidence
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
human papillomavirus vaccine, L1 type 16, 18
Appointments and Schedules
B-Lymphocytes
Injections

Keywords

  • Cervarix™
  • Gardasil®
  • Human papillomavirus
  • Immunogenicity
  • Safety

ASJC Scopus subject areas

  • Immunology
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Comparison of the immunogenicity and safety of Cervarix™ and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. / Einstein, Mark H.; Baron, Mira; Levin, Myron J.; Chatterjee, Archana; Edwards, Robert P.; Zepp, Fred; Carletti, Isabelle; Dessy, Francis J.; Trofa, Andrew F.; Schuind, Anne; Dubin, Gary.

In: Human Vaccines, Vol. 5, No. 10, 2009, p. 705-719.

Research output: Contribution to journalArticle

Einstein, MH, Baron, M, Levin, MJ, Chatterjee, A, Edwards, RP, Zepp, F, Carletti, I, Dessy, FJ, Trofa, AF, Schuind, A & Dubin, G 2009, 'Comparison of the immunogenicity and safety of Cervarix™ and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years', Human Vaccines, vol. 5, no. 10, pp. 705-719. https://doi.org/10.4161/hv.5.10.9518
Einstein, Mark H. ; Baron, Mira ; Levin, Myron J. ; Chatterjee, Archana ; Edwards, Robert P. ; Zepp, Fred ; Carletti, Isabelle ; Dessy, Francis J. ; Trofa, Andrew F. ; Schuind, Anne ; Dubin, Gary. / Comparison of the immunogenicity and safety of Cervarix™ and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. In: Human Vaccines. 2009 ; Vol. 5, No. 10. pp. 705-719.
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abstract = "This observer-blind study compared the prophylactic human papillomavirus (HPV) vaccines, Cervarix™ (GlaxoSmithKline) and Gardasil{\circledR} (Merck), by assessing immunogenicity and safety through one month after completion of the three-dose vaccination course. Women (n = 1106) were stratified by age (18-26, 27-35, 36-45 years) and randomized (1:1) to receive Cervarix™ (Months 0, 1, 6) or Gardasil{\circledR} (Months 0, 2, 6). At Month 7 after first vaccination, all women in the according-toprotocol cohort who were seronegative/DNA negative before vaccination for the HPV type analyzed had seroconverted for HPV-16 and HPV-18 serum neutralizing antibodies, as measured by pseudovirion-based neutralization assay (PBNA), except for two women aged 27-35 years in the Gardasil{\circledR} group who did not seroconvert for HPV-18 (98{\%}). Geometric mean titers of serum neutralizing antibodies ranged from 2.3-4.8-fold higher for HPV-16 and 6.8-9.1-fold higher for HPV-18 after vaccination with Cervarix™ compared with Gardasil{\circledR}, across all age strata. In the total vaccinated cohort (all women who received at least one vaccine dose, regardless of their serological and DNA status prior to vaccination), Cervarix™ induced significantly higher serum neutralizing antibody titers in all age strata (p < 0.0001). Positivity rates for anti-HPV-16 and -18 neutralizing antibodies in cervicovaginal secretions and circulating HPV-16 and -18 specific memory B-cell frequencies were also higher after vaccination with Cervarix™ compared with Gardasil {\circledR}. Both vaccines were generally well tolerated. The incidence of unsolicited adverse events was comparable between vaccinated groups. The incidence of solicited symptoms was generally higher after Cervarix™, injection site reactions being most common. However, compliance rates with the three-dose schedules were similarly high (≥ 84{\%}) for both vaccines. Although the importance of differences in magnitude of immune response between these vaccines is unknown, they may represent determinants of duration of protection against HPV-16/18. Long-term studies evaluating duration of efficacy after vaccination are needed for both vaccines.",
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AU - Chatterjee, Archana

AU - Edwards, Robert P.

AU - Zepp, Fred

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N2 - This observer-blind study compared the prophylactic human papillomavirus (HPV) vaccines, Cervarix™ (GlaxoSmithKline) and Gardasil® (Merck), by assessing immunogenicity and safety through one month after completion of the three-dose vaccination course. Women (n = 1106) were stratified by age (18-26, 27-35, 36-45 years) and randomized (1:1) to receive Cervarix™ (Months 0, 1, 6) or Gardasil® (Months 0, 2, 6). At Month 7 after first vaccination, all women in the according-toprotocol cohort who were seronegative/DNA negative before vaccination for the HPV type analyzed had seroconverted for HPV-16 and HPV-18 serum neutralizing antibodies, as measured by pseudovirion-based neutralization assay (PBNA), except for two women aged 27-35 years in the Gardasil® group who did not seroconvert for HPV-18 (98%). Geometric mean titers of serum neutralizing antibodies ranged from 2.3-4.8-fold higher for HPV-16 and 6.8-9.1-fold higher for HPV-18 after vaccination with Cervarix™ compared with Gardasil®, across all age strata. In the total vaccinated cohort (all women who received at least one vaccine dose, regardless of their serological and DNA status prior to vaccination), Cervarix™ induced significantly higher serum neutralizing antibody titers in all age strata (p < 0.0001). Positivity rates for anti-HPV-16 and -18 neutralizing antibodies in cervicovaginal secretions and circulating HPV-16 and -18 specific memory B-cell frequencies were also higher after vaccination with Cervarix™ compared with Gardasil ®. Both vaccines were generally well tolerated. The incidence of unsolicited adverse events was comparable between vaccinated groups. The incidence of solicited symptoms was generally higher after Cervarix™, injection site reactions being most common. However, compliance rates with the three-dose schedules were similarly high (≥ 84%) for both vaccines. Although the importance of differences in magnitude of immune response between these vaccines is unknown, they may represent determinants of duration of protection against HPV-16/18. Long-term studies evaluating duration of efficacy after vaccination are needed for both vaccines.

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