{"id":1172,"date":"2016-11-28T16:46:24","date_gmt":"2016-11-28T16:46:24","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/?p=1172"},"modified":"2017-08-21T10:32:13","modified_gmt":"2017-08-21T10:32:13","slug":"primary-care-corner-with-geoffrey-modest-md-2-dose-hpv-vaccine-for-girls-and-boys","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2016\/11\/28\/primary-care-corner-with-geoffrey-modest-md-2-dose-hpv-vaccine-for-girls-and-boys\/","title":{"rendered":"Primary Care Corner with Geoffrey Modest MD: 2-dose HPV vaccine for girls and boys"},"content":{"rendered":"<p><strong>By Dr. Geoffrey Modest<\/strong><\/p>\n<p>On 10\/19\/16, the CDC recommended that 9 to 14 year olds receive only 2 doses of the 9-valent HPV vaccine at least 6 months apart, instead of the prior recommendation for 3 doses.\u00a0But those who\u00a0started the series between ages of 15 through 26 continue to need 3 shots (see <a href=\"http:\/\/www.cdc.gov\/media\/releases\/2016\/p1020-hpv-shots.html\">http:\/\/www.cdc.gov\/media\/releases\/2016\/p1020-hpv-shots.html<\/a> for\u00a0the\u00a0press release). Here is the article it was based on (see\u00a0doi:10.1001\/jama.2016.17615).<\/p>\n<p>Details:<\/p>\n<ul>\n<li>Open-label, non-inferiority study done in 52 ambulatory sites in 15 countries, with 5 cohorts:\n<ul>\n<li>Girls aged 9 to 14, getting 2 doses 6 months apart (n= 301)<\/li>\n<li>Boys aged 9 to 14, getting 2 doses 6 months apart (n= 301)<\/li>\n<li>Girls and boys aged 9 to 14 getting 2 doses 12 months apart (n= 301)<\/li>\n<li>Girls age 9 to 14 getting 3 doses over 6 months, the current recommendation\u00a0(n= 301)<\/li>\n<li>Adolescent girls and young woman aged 16 to 26 getting 3 doses over 6 months, acting as the control group\u00a0(n= 314)<\/li>\n<\/ul>\n<\/li>\n<li>Mean age 11, BMI 20, 60% white\/17% Asian\/10% black, 25% North America\/20% Asian Pacific\/30% Europe\/15% Latin America\/8% Africa<\/li>\n<li>Eligible 9-14 yo&#8217;s\u00a0had to be generally healthy and not sexually active prior to enrollment. Those in the control group (age 16-26)\u00a0had to be generally healthy with 4 or fewer lifetime sexual\u00a0partners. All of the intervention groups were seronegative for each subtype prior to the 1<sup>st<\/sup> dose of vaccination<\/li>\n<li>The primary endpoint was the antibody response to each of the HPV types, assessed one month after the last dose of vaccine<\/li>\n<\/ul>\n<p>Results:<\/p>\n<ul>\n<li>More than 90% of participants in each cohort seroconverted to each HPV subtype<\/li>\n<li>HPV antibody responses in girls and boys given the 2 doses were not inferior to the control group (p\u00a0&lt; 0.001 for each HPV type).<\/li>\n<li>There was essentially no difference between boys&#8217; and girls&#8217; responses to the vaccine<\/li>\n<li>There was also no difference between those receiving the 2<sup>nd<\/sup> dose after 6 months or after 12 months, though\u00a0the antibody responses in those receiving the 2<sup>nd<\/sup>dose after 12 months were someone higher than after 6 months<\/li>\n<li>The antibody responses were roughly 2 to 3 times higher in the younger cohorts than the older control for each HPV type<\/li>\n<li>Post hoc analysis assessing antibody response 6 months after the last dose of vaccine declined in\u00a0all of the cohorts, but the antibody responses remained non-inferior in the 2-dose regimens<\/li>\n<li>22 participants had a serious adverse event, all not considered to be related to the vaccine. One person discontinued the study because of transient urticaria<\/li>\n<\/ul>\n<p>Commentary:<\/p>\n<ul>\n<li>The 9-valent HPV vaccine provides protection against 7 high-risk HPV types responsible for 90% of cervical cancers or other anogenital cancers, as well as 2 other types responsible for 90% of genital warts.<\/li>\n<li>The WHO in 2014 changed their recommendations for girls aged 9 to 14 from a 3 dose to a 2 dose schedule (at 0 and 6 months).<\/li>\n<li>Other studies have suggested that a longer interval between the 1<sup>st<\/sup> and 2<sup>nd<\/sup> dose is more immunogenic, and that a 2<sup>nd<\/sup> dose earlier than 5 months after the 1<sup>st<\/sup> dose seems to be less effective;\u00a0i.e. the second dose should not be before 6 months, and is more immunogenic at least in the short-term\u00a0if given after\u00a012 months as\u00a0in the above study, or perhaps\u00a0even later (the CDC press release only states that the second dose should be at least 6 months later)<\/li>\n<li>Other studies of also found that coadministration of the 9-valent HPV vaccine with diphtheria, tetanus, pertussis, polio, and meningococcal vaccines can be done\u00a0at the same visit.<\/li>\n<li>This study did not have clear clinical outcomes, though it seems to me that antibody response is a reasonable surrogate marker for clinical protection. A prior blog (see <a href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/04\/01\/primary-care-corner-with-geoffrey-modest-md-hpv-vaccine-recommendation-update\/\">https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/04\/01\/primary-care-corner-with-geoffrey-modest-md-hpv-vaccine-recommendation-update\/<\/a>\u00a0, or see Joura EA. N Engl J Med 2015; 372: 711) dealt with the initial recommendations for\u00a0the 9-valent vaccine, showing that not only was this vaccine immunogenic, it was also quite safe, and provided <strong>7% efficacy<\/strong> in preventing &gt;=\u00a0CIN2 lesions. &#8212;\u00a0And HPV vaccine is not only quite expensive, it is also very painful and requires more medical visits to do 3 vs\u00a02 injections.<\/li>\n<li>It should be noted that there are no data showing what the minimum clinically-effective protective titer is for HPV vaccination<\/li>\n<li>The investigators will be following antibody persistence and the duration of protection over time.<\/li>\n<li>This study was designed to look at a younger cohort because of their increased HPV-vaccine\u00a0immunogenicity, as documented in other studies (and confirmed in this study). It certainly seems reasonable that a subsequent study should look at the\u00a0effectiveness\u00a0of 2-dose regimens for those older than 14\u00a0and those who have been more\u00a0sexually active\/have evidence of prior infection by some of the HPV types.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Primary Care Corner with Geoffrey Modest MD: 2-dose HPV vaccine for girls and boys [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2016\/11\/28\/primary-care-corner-with-geoffrey-modest-md-2-dose-hpv-vaccine-for-girls-and-boys\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":148,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14283],"tags":[],"class_list":["post-1172","post","type-post","status-publish","format-standard","hentry","category-archive"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/1172","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/users\/148"}],"replies":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/comments?post=1172"}],"version-history":[{"count":0,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/1172\/revisions"}],"wp:attachment":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/media?parent=1172"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/categories?post=1172"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/tags?post=1172"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}