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Quadrivalent HPV vaccine safe, effective in preteens and teens
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When used in preadolescents and adolescents, quadrivalent HPV vaccine demonstrates immunogenicity, effectiveness and tolerability after 10 years in those who receive three doses, according to a study published in Pediatrics.
“All preadolescents and adolescents should receive the HPV vaccine,” Daron G. Ferris, MD, a professor in the department of obstetrics and gynecology at the Georgia Cancer Center within Augusta University, told Infectious Diseases in Children. “Health care providers for children must now ensure universal vaccination coverage to prevent unnecessary morbidity and premature mortality.”
To examine the data on preadolescents and teenagers regarding a 10-year, long-term follow-up study of quadrivalent HPV (4vHPV) vaccine, the researchers conducted a base study in which sexually inactive boys and girls were administered the immunization. Another group received a placebo, and all immunizations and placebos were given at day 1, month 2 and month 6. The cohort that received the placebo vaccine was immunized with 4vHPV at month 30, and the same vaccination schedule was used.
Ferris and colleagues examined the preteens and teenagers for long-term development of anti-HPV type 6, 11, 16 and 18 immune responses. The incidence rate of these types of immune responses, as well as disease related to HPV or persistent infection, were used to determine vaccine efficacy.
Of the 1,661 preadolescents and adolescents included in the study, seropositivity was observed in 89% to 96% 10 years after immunization. At month 7, preadolescents had higher geometric mean titers (38% to 65% higher). These continued to remain higher at 10 years (16% to 42% higher) when compared those of with adolescents.
In both cohorts, the preteens and teenagers did not have any cases of HPV type 6, 11, 16 or 18, nor were any related diseases observed. Persistent infection for at least 6 months was observable in 10 participants with vaccine-type HPV; two participants had a persistent infection for at least 12 months. Throughout the study period, no serious adverse events were reported.
“These very positive long-term findings essentially dispel any lingering doubts about HPV vaccine efficacy and safety,” Ferris said. “You can now prevent a multitude of cancers in all your eligible patients.”
The quadrivalent HPV vaccine is marketed in the U.S. under the brand name Gardasil (Merck). – by Katherine Bortz
Disclosures: The authors report no relevant financial disclosures.
Perspective
Back to TopPaul A. Offit, MD
In 2006, the Advisory Committee on Immunization Practices (ACIP) recommended the human papillomavirus (HPV) vaccine for adolescent girls between 11 and 13 years of age. In 2010, that recommendation was extended to include adolescent boys. At the time of licensure, the HPV vaccine, which then contained four serotypes (6, 11, 16, and 18), had been shown to be safe and effective in a large pre-licensure trial of 9- to 15-year-old boys and girls.
The study by Daron Ferris and coworkers represents a 10-year follow-up of this original study. Investigators found that 89% to 96% of vaccines remained seropositive for 10 years post-vaccination, that no cases of HPV types 6, 11, 16, and 18 were observed, and that no serious adverse events were reported.
This study should further reassure doctors and their patients that the HPV vaccine—which as a 9-valent vaccine now has the capacity to prevent about 29,000 cases of cancer and 5,000 deaths from cancer every year — provides durable protection without any serious side effects. The only question that remains is why are some parents still hesitant to give this safe, cancer-preventing vaccine to their children.
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