PHILADELPHIA, PA—Concomitant administration of a licensed quadrivalent human papillomavirus (HPV4) vaccine and bivalent rLP2086, an investigational Neisseria meningitidis serogroup B (MnB) vaccine, generated robust immune responses to both vaccines in healthy adolescents, a study reported at IDWeek 2014.
Bivalent rLP2086 comprises two antigens, one recombinant lipidated protein variant from subfamily A (A05) and one from subfamily B (B01), noted John L. Perez, MD, MA, Senior Medical Director of Pfizer Vaccine Research, Collegeville, PA.,
The Phase 2 study randomized 2,499 subjects 11–17 years of age 2:2:1 to three groups: Group 1 (n=992) received bivalent rLP2086 and HPV4; Group 2 (n=990), bivalent rLP2086 and saline; and Group 3 (n=501), saline and HPV4 at Months 0, 2, and 6. Mean age at first vaccination was 13.6 years; the majority of the subjects were white (81.6%) and male (66.5%). “Blood samples were drawn at baseline and approximately 1 month after vaccinations 2 and 3,” Dr. Perez reported.
Geometric mean titers (GMTs) against HPV antigens 6, 11, 16, and 18 in Groups 1 and 3 and human complement serum bactericidal assay (hSBA) GMTs against meningococcal group B disease test strain variants A22 and B24 were the primary immunogenicity endpoints, measured after the third dose. Secondary immunogenicity endpoints included rate of seroconversion to HPV antigens.
Results showed the prespecified noninferiority criteria were met for HPV antigens 6, 11, and 16 and both meningococcal group B disease test strains. Seroconversion for all four HPV antigens was achieved by ≥99% of the subjects for the groups that received HPV4 concomitantly with bivalent rLP2086 or with saline.
Compared with saline, more local reactions (injection site pain and redness and swelling) occurred after the bivalent rLP2086 vaccine was administered; however, these reactions did not increase with subsequent vaccinations. Rates of local and systemic reactions (fatigue, headache, and fever) were comparable when rLP2086 was given with the HPV4 vaccine versus rLP2086 alone.
The geometric mean ratios to HPV18 “narrowly missed the noninferiority criterion, but the high proportion of responders indicates an expectation of clinical effectiveness after concomitant administration,” Dr. Perez reported. “The anti-HPV GMT titers achieved by subjects receiving bivalent rLP2086 and HPV4 were higher than those observed in the pivotal HPV4 efficacy studies.”
These results demonstrate that coadministration of bivalent rLP2086 and HPV4 is well tolerated, convenient, “and may increase adherence to recommended immunization schedules,” he concluded.