ACIP Considers Single-Dose HPV Vaccination

 At its meeting on Tuesday, the CDC's Advisory Committee on Immunization Practices (ACIP) considered whether the U.S. should move to single-dose human papillomavirus (HPV) vaccination instead of the currently recommended schedule.

At present, the U.S. recommends two doses of HPV vaccine if they are started before age 15, and three doses if they are started at age 15 or older, and for people who are immunocompromised. Routine vaccination starts at age 11 or 12 -- though it can be started at age 9 -- while catch-up vaccination is recommended through age 26. Shared clinical decision making is advised for those 27 to 45.

However, global HPV vaccination schedules have shifted in recent years, with the World Health Organization recommending in 2022 a two-dose schedule for those 9 and older, with an option for a one-dose schedule for those between 9 and 20. The U.K. and Australia have adopted this schedule, too.

"As of now ... in some age groups, 67 countries have adopted one-dose and 77 countries have adopted two-dose HPV vaccination schedules," Oliver Brooks, MD, chief medical officer at Watts Healthcare Corporation in Los Angeles, said during his presentation.

The HPV vaccination working group noted that the KEN SHE trial, published in NEJM Evidenceopens in a new tab or window in 2022, showed that among Kenyan women ages 15 to 20, single-dose HPV vaccination had 98% efficacy against HPV 16 and 18, according to the trial's protocol chair Ruanne Barnabas, MBChB, DPhil, chief of the division of infectious diseases at Massachusetts General Hospital in Boston.

The trial's endpoint was incident persistent vaccine type-specific cervical infection among participants who were HPV naive at vaccination. In the nonavalent group -- the HPV vaccine used in the U.S. -- there was just one case of cumulative incidence of HPV over 3 yearsopens in a new tab or window compared with 72 cases in the control group. Barnabas also noted that the trial found "no evidence of waning of this protection."

Workgroup co-lead Lauri Markowitz, MD, from CDC's National Center for Immunization and Respiratory Diseases, said the next ACIP meeting in June will have data from the ESCUDDO randomized control trialopens in a new tab or window out of Costa Rica, which evaluated non-inferiority of one versus two doses of HPV vaccine.

Another major discussion centered on whether to change the wording of the HPV vaccine age recommendation.

The current language is that "CDC recommends two doses of HPV vaccine at ages 11-12 years" but "HPV vaccination can be started at age 9 years." The workgroup is considering modifying this language to "HPV vaccination is routinely recommended at age 9 to 12 years," which may allow for more flexibility. The American Academy of Pediatricsopens in a new tab or window has already adopted this language.

Charlotte Moser, MS, co-director of the Vaccine Education Center at Children's Hospital of Philadelphia, noted that this change is fundamentally about communications. She asked the workgroup to consider how changing the wording on this recommendation may impact parental pushback because already some "parents aren't comfortable with the fact that it prevents against a sexually transmitted disease" and thus "we could be doing ourselves a disservice in the larger scope of HPV uptake."

Advisors did not vote on any of these issues, and a final vote is expected at the next meeting in June.

Georgina Amaral, MD, an ob/gyn with UTHealth Houston specializing in adolescents and teens, who is not on the panel, said many ob/gyns are hoping the evidence will support a reduced dose schedule and changed language.

"The most important thing with any of the vaccination schedules is that the vaccine is given before any potential exposure," Amaral said. "We've known long before the vaccine was available that conditions like cervical cancer and HPV-related diseases tend to [disproportionately] affect the most vulnerable populations."

She said fewer doses mean easier logistics for families and easier buy-in on getting vaccinated. It also makes it harder for patients to slip through the cracks and miss vaccination. Plus, the HPV vaccine is known to sting, and having fewer injections would make this experience easier on patients.

"Most people are excited and hopeful if we can make this better for patients and families," Amaral said. "I would be thrilled if we get enough efficacy data to make that just a little bit more streamlined."

https://www.medpagetoday.com/meetingcoverage/acip/115151