qA store that I follow [on Facebook] just shared this article. [The article states that Merck — the company that manufactures Gardasil — will soon “push” all infants in the US to receive the HPV vaccine and is currently testing the vaccine on infants.] It seems highly unlikely to me that this is true, but all my quick Google search turns up are from similar sites whose information is just as suspect. I was wondering if you could shed some light on this.
– Bonney, via Facebook

I was skeptical of this claim as well, however, after a little digging it turns out there is a kernel of truth at the center of this claim, but it has been grossly misrepresented in the article you read.

There is a clinical trial out of the National Institute of Child Health in Budapest, Hungary that is investigating the efficacy of using the 4-valent HPV vaccine to treat children between the ages of one and 17 with juvenile-onset recurrent respiratory papillomatosis (JoRRP). If you haven’t heard of JoRRP before that’s because it’s not all that common in North America, however, it is rather severe for those children who do have it. Children with JoRRP develop warts in their airway. These warts restrict or block their ability to breathe, and the nature of the warts makes it difficult to reopen their airways.

The warts that cause JoRRP are caused by the same strains of HPV that also cause cervical cancer. Children with JoRRP likely acquire the virus from their mother during the labor and delivery process. Children born to younger mothers with lower levels of education and income are disproportionately more likely to develop JoRRP than the general population. Hungary has one of the highest rates of teen motherhood in the European Union, which is likely why the study is being carried out there.

To be included in the Hungary study a child must meet certain parameters. The study is specifically closed to children that are otherwise healthy. To be included in the study, an ear nose and throat (ENT) doctor must confirm a child’s JORRP diagnosis. The child must also have experienced at least three episodes wherein the warts inhibited their ability to breathe, and have blood work that falls within the parameters set out by the researchers.

Unfortunately it looks like the author of the article you sent misread or misunderstood the age range parameters in the clinical trial. Newborns and infants are specifically excluded from the Hungary trial, however the study is open to toddlers. The misunderstanding seems to come from this paragraph:

“After an initial immunological and ear-nose-throat (ENT) assessment, children with at least 3 relapses in their patient history will be vaccinated with the 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination … 3. Follow-up: 1 month after 3rd vaccine dose – immunological assessment (same tests as in the enrollment phase) 6, 12 and 18 months after the 3rd vaccine dose – ENT + oesophagoscopy”.

What this means is that children will receive the 4-valent vaccine upon being screened into the study (this is zero months), they will receive their second dose two months after their first dose and the final dose will be received six months after their first dose. Once the children have received their last dose of the vaccine the researchers will follow up with them after one month, six months, 12 months and 18 months.

So if this is all happening in Hungary where rates of JoRRP are higher, why is this clinical trial listed on the NIH’s website?  It likely has to do with Merck’s involvement.  Merck is listed as a collaborator on the trial, and the arm of Merck that’s involved is headquartered in New Jersey.  This is likely what required them to get approval through NIH for the trial, even though the primary investigator, recruitment and subjects are all based in Hungary.  It’s also a little misleading for the article to claim that Merck is conducting the trial, when the primary investigator is listed Dr. Zsofia Meszner of the National Institute for Child Health in Hungary.  Merck’s role in the study isn’t clear yet, however, it may be as simple as providing the investigators with the vaccines needed for the study.

Merck’s role in the study will become clearer when the results are published.  The primary data collection phase is set to end in January 2017, so it may be a little while before we see the publication of the results.

As we say frequently on this site, a single study does not science make.  To say that this single study in a highly specific population in Hungary means that Merck will soon “push” the HPV series on all infants in the US is a huge leap in logic and there’s no evidence to back it up.

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Categories: Infectious Disease + Vaccines, Science 101 + Mythbusting