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Research Paper

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 and Gary Dubin

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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-to-protocol 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.

Authors

Mark H. Einstein Corresponding author: meinstei@montefiore.org

Montefiore Medical Center, Albert Einstein College of Medicine, Department of Obstetrics & Gynecology and Women’s Health, Division of Gynecologic Oncology, Bronx, NY, United States

Mira Baron

Rapid Medical Research, Cleveland, OH, United States

Myron J. Levin

University of Colorado Denver and Health Sciences Center, Aurora, CO, United States

Archana Chatterjee

Creighton University School of Medicine, Omaha, NE, United States

Robert P. Edwards

Ovarian Cancer Center of Excellence/Sciences University of Pittsburgh School of Medicine, Pittsburgh, PA, United States

Fred Zepp

Pediatric Immunology & Infectious Diseases; Children's Hospital; Johannes Gutenberg University of Mainz; Mainz, Germany

Isabelle Carletti

GlaxoSmithKline Biologicals, Rixensart, Belgium

Francis J. Dessy

GlaxoSmithKline Biologicals; Rixensart, Belgium

Andrew F. Trofa

GlaxoSmithKline Biologicals, King of Prussia, PA, USA

Anne Schuind

GlaxoSmithKline Biologicals, King of Prussia, PA USA

Gary Dubin

GlaxoSmithKline Biologicals; King of Prussia, PA USA

This is an open-access article

 Download PDF

If the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.