Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15–55 years

Ten‐year immune persistence and safety of the HPV‐16/18 AS04‐adjuvanted vaccine in females vaccinated at 15–55 years of age

“…Antibody titers at Year 10 were still at least three times higher than those observed after natural infection across all age groups, and in the older age categories (≥25 years), titers were similar to or just below the plateau levels associated with long‐term efficacy 14, 22. These findings were in line with the results of the primary study and consistent with our expectations, since GMTs are known to decline with increasing age at vaccination 9. These results, along with the sustained efficacy seen in another study for up to 7 years post vaccination in women aged ≥25 years, suggest that the vaccine may confer protection for up to 10 years and possibly longer, even in older subjects 11.…”

Comparison of the immunogenicity and safety ofCervarix™ andGardasil®human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18–45 years

“…Antibody extraction from CVS samples was performed as described previously 61 Pseudovirion-based neutralization assay. Serum and CVS anti-HPV-16 and -18 neutralizing antibody titers elicited by Cervarix™ or Gardasil ® were measured using PBNA 35 at GlaxoSmithKline (GSK) laboratories where the methodology underwent further validation.…”

“…Quantitation of HPV-16 and HPV-18 antibodies in all CVS samples was also performed by ELISA using the purified type-specific recombinant VLPs present in Cervarix™ as coating antigen and adapted for CVS samples, as described previously. 61 IgG antibody titers (expressed as ELISA units [EU]/mL) were calculated by reference to standards using a four-parameters equation for each sample dilution, and the titer of each sample was calculated as the average of all titers within the proportional range of the reference curve. The final antibody titer was multiplied by the dilution factor obtained during the antibody extraction step.…”

“…Additional samples were collected from a subset of women (planned for approximately 30% of the total number of enrolled women per age cohort at pre-selected sites) at Day 0 and Month 7 for further immunological assessment, including evaluation of HPV type-specific antibody levels in CVS and HPV type-specific memory B-cell responses. CVS samples were collected using sterile Merocel ® Sponge Points (Medtronic, Jacksonville, FL) as described previously 61 and menstrual cycle duration and date of last menstrual period were recorded. In cases of menstruation/ bleeding, the collection of samples was delayed until one day after cessation of menstrual flow.…”

Selection of Adjuvants for Enhanced Vaccine Potency

“…Therefore, combining two or more adjuvants may further enhance the degree of immune response due to simultaneous, multiple mechanisms of actions [385]. In several studies, combination of aluminum salts and deacylated MPL was shown to induce a robust and persistent immune response with HPV-16/18 protein VLP vaccine in women (Cervarix, GSK Biologicals) [431] and more effective with a hepatitis B vaccine than the commercial product Engerix-B in humans [432]. Another reason for combing adjuvants is to change the type of immune response.…”