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Two-dose regimens of Gardasil 9 noninferior to three-dose regimens
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Two-dose regimens of Gardasil 9 separated by 6 or 12 months in girls and boys aged 9 to 14 years were noninferior compared with a three-dose regimen of the 9-valent HPV vaccine delivered over 6 months in adolescent girls and young women aged 16 to 26 years, according to the results of a clinical trial.
Using a two-dose HPV vaccination schedule — now recommended in the United States for younger adolescents — could potentially reduce costs related to the infection, Ole-Erik Iversen, MD, PhD, of the department of obstetrics and gynecology at Haukeland University Hospital and professor at the University of Bergen, Norway, and colleagues wrote in JAMA.
“In many countries, HPV vaccination rates remain suboptimal. Using an effective two-dose regimen entailing fewer visits could improve adherence to HPV vaccination programs,” they said. “Co-administration of the 9-valent HPV vaccine with diphtheria, tetanus, pertussis, polio and meningococcal vaccines could also be completed at the same visit, which has been demonstrated in clinical studies.”
Iversen and colleagues conducted an open-label, noninferiority, immunogenicity trial at 52 ambulatory care settings in 15 countries between Dec. 16, 2013 and June 19, 2015. Two-dose regimens of Gardasil 9 (Merck) in cohorts of boys and girls aged 9 to 14 years were compared with the previously standard three-dose schedule administered to adolescent girls and young women over 6 months. Antibody response was assessed 1 month after the final dose.
An analysis of 1,377 participants found that HPV antibody responses in girls and boys on the two-dose regimens separated by 6 or 12 months were noninferior to those of the control group.
“Further research is needed to assess persistence of antibody responses and effects on clinical outcomes,” Iversen and colleagues said.
In October, the CDC’s Advisory Committee on Immunization Practices recommended that adolescents vaccinated before age 15 years receive only two doses of HPV vaccine 6 months or more apart to prevent viral-causing cancers and infections.
The policy change was based in part on data from the clinical trial conducted by Iversen and colleagues, Lauri E. Markowitz, MD, of the division of viral diseases in the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues noted in a related editorial.
Markowitz and colleagues said a potential added benefit of the revised CDC recommendation is that vaccine acceptability and uptake may increase.
“During the first decade of the HPV vaccination program, knowledge has increased about these highly effective HPV vaccines. Population-level effects of vaccination programs on infection and disease outcomes have exceeded expectations in many countries, and extensive safety evaluations have not identified concerns,” they wrote. “In the second decade, reduced dose schedules might help achieve higher HPV vaccination coverage, advance HPV vaccine program introductions in more countries, and further reduce the burden of HPV–associated cancers and disease worldwide.” – by Gerard Gallagher
Disclosures: Please see the full study for a list of all authors’ relevant financial disclosures.
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