Hello. I’m Dr Maurie Markman, from City of Hope. I’d like to briefly discuss a very interesting abstract. In these sessions, I have particularly focused on published, peer-reviewed articles. This particular abstract, I believe, was so important that I really wanted to discuss it here briefly in abstract form.
Now, it’s certainly possible when this video is shown to you that there will be a resolution and forward movement regarding the topic. One would hope so, but perhaps not. I think you’ll understand more in a moment what I’m referring to.
I would like to discuss a trial result reported at the 2025 AACR Annual Meeting. The abstract dealt with the ESCUDDO trial. I don’t know exactly how one would pronounce that, but it was a phase 3, randomized trial initiated in 2017 in Costa Rica, sponsored by the National Cancer Institute.
It very specifically — and in my opinion, very definitively — addressed the question of the utility and the effectiveness of a single vaccination with an HPV vaccine vs the standard of care, which is two doses.
This was a study that involved 20,000 girls aged 12-16 years, who received either one or two doses of either the bivalent or nonavalent HPV vaccine. When this was started in 2017, there were different strategies that were used at that particular time. You can think about this, in some ways, as a four-arm randomized trial. On the other hand, you could certainly also look at the two doses vs one dose together.
Importantly, the way the study was done, which I think was innovative and quite appropriate, was there were two randomizations. The first was to the bivalent or the nonavalent vaccine. Then, when it came time for the second dose, the patients either got a second dose or they got an unrelated, non-HPV vaccine. It could have been an immunization for tetanus or something like that, for example.
There was a blinding, certainly, to the patients and to the investigators of whether they were receiving two doses vs one. Again, you got two doses, but of course, the people running the study knew whether the patients got two doses or one.
All these individuals who received vaccination were followed every 6 months through 5 years with self-collected cervical samples. In addition, the investigators compared the outcomes to a group of 3000 young women aged 16.5-21.5 years of age. They documented HPV infection status and, 6 months later, the persistence of HPV. They matched the patients in the clinical trial to this population for age as well as geographic region.
Importantly, this was a noninferiority design. It’s the high standard — noninferiority — to demonstrate that the single dose was as effective as the two doses. The bottom line was that it achieved the endpoint. The single dose was 97% effective.
Obviously we’ll wait to see what the FDA and the CDC say, as there’s a lot going on these days in terms of discussion about vaccines, but the bottom line is that I think the data are now pretty clear. There are other data as well, but this is a definitive trial that single-dose HPV vaccination is extremely effective and should be the standard of care.
The importance of this is, number one, the cost of vaccination will go down tremendously. Single dose means you give a dose and you don’t have to worry about follow-up. You don’t have to ask if you came back when you should have come back or try to find the individuals to discuss further why you need a second dose. It’s a single dose and that individual is remarkably protected from cervical cancer, but also from other HPV-related malignancies.
I cannot emphasize enough; it is not possible to overstate the importance of HPV vaccination. This study — and we’ll see what happens — goes a long way to helping establish this as, in my opinion, part of routine immunization for adolescents in the United States and worldwide.
Thank you for your attention.
