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University release breaks cardinal transparency rule. Vaccine was tested in animals, not humans

IMAGE
IMAGE: David Bulir, who just completed his Ph.D. at McMaster University and is co-author of the study. view more

Credit: McMaster University.

Hamilton, ON July 19, 2016 — The first steps towards developing a vaccine against an insidious sexual transmitted infection (STI) have been accomplished by researchers at McMaster University.

Researchers at the Michael G. DeGroote Institute for Infectious Disease Research at McMaster have developed the first widely protective vaccine against chlamydia, a common STI that is mostly asymptomatic but impacts 113 million people around the world each year and can result in infertility.

In a study, recently published in the journal Vaccine, the researchers show that a novel chlamydial antigen known as BD584 is a potential vaccine candidate for the most common species of chlamydia known as Chlamydia trachomatis.

As most C. trachomatis infections are asymptomatic, chlamydia can often go untreated and lead to upper genital tract infections, pelvic inflammatory disease, and infertility. This is why the promise of a vaccine would be extremely beneficial, says David Bulir, co-author of the study.

“Vaccine development efforts in the past three decades have been unproductive and there is no vaccine approved for use in humans,” said Bulir, who just finished his PhD in medical sciences at McMaster.

“Vaccination would be the best way to way to prevent a chlamydia infection, and this study has identified important new antigens which could be used as part of a vaccine to prevent or eliminate the damaging reproductive consequences of untreated infections.”

In the research team’s study, BD584 was able to reduce chlamydial shedding – a symptom of C. trachomatis – by 95 per cent. The antigen also decreased hydrosalpinx, another C. trachomatis symptom which involves fallopian tubes being blocked with serous fluids, by 87.5 per cent.

The results look very promising, said senior author James Mahony, a professor of Pathology and Molecular Medicine for McMaster’s Michael G. DeGroote School of Medicine and a researcher at St. Joseph Healthcare Hamilton’s Research Institute where the work was performed.

Co-author and McMaster PhD student, Steven Liang, explains, “not only is the vaccine effective, it also has the potential to be widely protective against all C. trachomatis strains, including those that cause trachoma.”

Trachoma is an eye infection caused by chlamydia and is the leading cause of preventable blindness affecting millions of people in many resource-poor regions of the world.

“The vaccine would be administered through the nose. This is easy and painless and does not require highly trained health professionals to administer, and that makes it an inexpensive solution for developing nations,” he said.

The next step is more testing for effectiveness against different strains of Chlamydia and in different formulations. The study was funded by the Canadian Institutes for Health Research.

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Editors:

  • Downloadable photos of the researchers are available online: David Bulir, James Mahony and Steven Liang
  • McMaster provides a high definition broadcast studio that can connect with any television broadcaster around the world.

To book an interview, please contact:
Tucker Wilson
Media Relations
Faculty of Health Sciences
McMaster University
(905) 525-9140, ext. 22863
Wilsot16@mcmaster.ca

Researchers produce first widely protective vaccine against chlamydia

Our Review Summary

Laboratory mouseIn many ways, this release provides much of the basic information reporters would need to determine how newsworthy the findings are. Where it was published. The specific antigen being studied and for which disease. A numerical breakdown of the benefits. But nowhere does it mention that this was a study conducted in mice and that, if past experiences with vaccines for other diseases hold true, a true vaccine for humans has a narrow chance of becoming a reality.

 

Why This Matters

Chlamydia is the most commonly reported sexually transmitted disease (STD) in the United States, according to the Centers for Disease Control and Prevention. The CDC says the condition is easily treated, but if left untreated, can make it difficult for a woman to become pregnant

A further complication of chlamydia is that it often carries no symptoms, so someone who is infected may not even know it. A safe and effective vaccine would certainly be of public health interest. But this research has to far to go before it will be available to the public — if ever.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Because the release is presented as if the study were conducted in humans, we would expect to see some explanation of what the vaccine might cost.

A better news release might have commented on the potential costs (and time) required for testing a new vaccine and bringing it to market.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release mentions the antigen being studied, BD584, “was able to reduce chlamydial shedding – a symptom of C. trachomatis – by 95 per cent.” Without any context for how many people (or mice in this case) were studied, we have no way of knowing what that means.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

There is no mention of harms in the release. Did any of the mice die or develop sterility or pelvic inflammatory disease?

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

This is the biggest omission in the release and truly surprising for a university. The study itself discusses in detail how the work was conducted in mice. And yet the release says nothing of the sort and, in fact, is set up in such a way that the strong impression is given that this study was conducted in humans. For example, the release says up high, “Researchers at the Michael G. DeGroote Institute for Infectious Disease Research at McMaster have developed the first widely protective vaccine against chlamydia. This is quickly followed by the first quote in the release, which says:

“Vaccine development efforts in the past three decades have been unproductive and there is no vaccine approved for use in humans,” said Bulir, who just finished his PhD in medical sciences at McMaster.

Until one read the actual study they’d have assumed that this was a human vaccine trial.

All of this makes the comments about the potential benefits for human trachoma infections even more absurd.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in the story.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release notes that the Canadian Institutes for Health Research funded the study.

Does the news release compare the new approach with existing alternatives?

Not Applicable

There is no other pharmacological treatment for preventing the chlamydia infection currently available so we rate this “not applicable.” However, it might have been noted that most public health experts recommend condoms for preventing this and other sexually transmitted diseases.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The release makes no mention of the fact that this vaccine is very far away from a clinical application, assuming it would even pass human trials. Instead, it talks about how easy the vaccine would be to administer and how people wouldn’t even need a lot of training to administer it.

(We imagine that administering nasal doses to mice would require some training.)

Does the news release establish the true novelty of the approach?

Satisfactory

There’s no shortage of claims of novelty in the release, including in the headline. Although the release is misleading about the study cohort, it is a novel study given the absence of any available chlamdyia vaccines.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

We would say that the entire release is unjustifiable given the lack of a mention of the true nature of the study. We also wonder if the investigators were given the opportunity to review the release before it went out.

Total Score: 3 of 9 Satisfactory

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