Moderator of 4 Sessions
Presenter of 2 Presentations
MANAGEMENT OF HPV-RELATED DISEASE IN TRANSPLANT RECIPIENTS AND OTHER IMMUNOSUPPRESSED HOSTS
SINGLE DOSE OF NONAVALENT PROPHYLACTIC HPV VACCINE INDUCES STABLE HPV16 AND HPV18 ANTIBODY RESPONSES UP TO 24 MONTHS AMONG 9-11 YEAR-OLD GIRLS AND BOYS
Abstract
Introduction
Emerging data suggest that a single dose of the bivalent or quadrivalent HPV vaccine generates antibody responses and efficacies similar to 2-dose schedules in children. No similar data are yet available for the nonavalent vaccine (9vHPV). Such data may inform policy considerations around usage of a single dose of 9vHPV to reduce costs of vaccination worldwide.
Methods
This is a prospective, single-arm, open-label, non-randomized, Phase IIa trial to determine the stability of HPV type-specific antibody responses up to 24 months after a single dose of 9vHPV in 201 healthy 9–11-year-old girls and boys. Subjects received a single dose of the 9vHPV at baseline, a delayed 2nd dose at month 24, and an optional 3rd dose at month 30. Blood samples were collected at baseline and at 6, 12, 18, 24, and 30 months after the prime dose. Primary outcomes were serum geometric mean concentrations (GMC) of HPV-16 and HPV-18 IgG antibodies.
Results
Demographics are shown in Table 1. GMCs of HPV16 and HPV18 antibodies are shown in Table 2. Table 3 shows high GMC at 6 months that declined between months 6 to 12, and stabilized between months 12, 18, and 24 (meeting the pre-specified hypotheses of non-inferior responses). The GMC were stable (or slightly higher) among 87.7% participants between months 12 and 24; among the remaining participants none showed consistent declines declines between both 18- vs. 12- and 24- vs. 18-months timepoint comparisons. Almost all participants (97%/96%) had significantly boosted responses for HPV16/HPV18 after the 3rd dose. One participant (0.5%) did not seroconvert after the single dose.
Conclusions
A single dose of 9vHPV induced persistent and stable antibody responses up to 24 months in the majority of participants, and a delayed dose at 24-months induces robust anamnestic responses. Declines and irregularities in antibody levels merit further study.