Søren Hough

Hepatitis B vaccine trial is suspended, not canceled The Bandim Health Project says it’s working on changing its protocol to address concerns while doubling down on its claim that the study design is ethical.

Unfortunately, that's not quite the case. Africa CDC has made it clear the trial is still only suspended and that they're working with the GB government to evaluate the protocol. The study leads are also planning to resubmit their proposal for review.

www.bioxconomy.com/modalities/h...

Sat på pause, men ikke aflyst?
🧐🤨

Just for reference, Africa CDC and the trial's lead investigators both describe the project as "suspended."

bsky.app/profile/dori...

Hepatitis B vaccine trial is suspended, not canceled The Bandim Health Project says it’s working on changing its protocol to address concerns while doubling down on its claim that the study design is ethical.

Apparently, it is not yet dead.
"Hepatitis B vaccine trial is suspended, not canceled, per Africa CDC"

www.bioxconomy.com/modalities/h...

Hepatitis B vaccine trial is suspended, not canceled The Bandim Health Project says it’s working on changing its protocol to address concerns while doubling down on its claim that the study design is ethical.

www.bioxconomy.com/modalities/h...

Hepatitis B vaccine trial is suspended, not canceled The Bandim Health Project says it’s working on changing its protocol to address concerns while doubling down on its claim that the study design is ethical.

Full article, no paywall: www.bioxconomy.com/modalities/h...

Long story short, the trial remains suspended, not canceled, and its leads are working on updating their study protocol as we speak.

Thank you to Brian Gazaille once again for your editorial support in getting this piece out!

Black and white photo of a mother with her child in Guinea-Bissau in March 1973

Joshua Abbott and I are back with another update on the proposed hepatitis B vaccine trial in Guinea-Bissau. We bring together our own sources and those highlighted in an excellent recent report from @rollingstone.com to piece together the current status of the project.

I read the piece - it's fabulous reporting. More of the puzzle falls into place. SDU has a lot of questions to answer, as do Danish and US authorities, I believe.

Hepatitis vaccine trial bucks ethics standards, says WHO The study would mean applying a “double standard” to standards of care between the sponsoring countries – Denmark and the US – and the host country.

Guinea-Bissau vaccine trial bucks precedent and international ethics standards, says WHO
The study would mean applying “double standards” to care between the sponsoring countries – Denmark and the US – and the host country.
www.bioxconomy.com/modalities/g...

Hepatitis vaccine trial bucks ethics standards, says WHO The study would mean applying a “double standard” to standards of care between the sponsoring countries – Denmark and the US – and the host country.

"... Regional Committees on Health Research Ethics for Southern Denmark (RSYD)...statement:
"[we] received an inquiry regarding ...a hepatitis B vaccine trial being planned for Guinea-Bissau.
The inquiry is currently under review.""
www.bioxconomy.com/modalities/g...

Hepatitis vaccine trial bucks ethics standards, says WHO The study would mean applying a “double standard” to standards of care between the sponsoring countries – Denmark and the US – and the host country.

Stabell Benn: "Under Danish regulations, ethics committees in Denmark do not review protocols for studies conducted entirely outside Denmark."

"That statement contradicts both the Declaration of Helsinki and the statements BioXconomy received from Danish institutions..."

Ny interessant artikel ⬇️ 👀

BREAKING: The Health Research Ethics Committee for the Region of Southern Denmark has responded to BioXconomy to acknowledge that it is investigating whether this trial met notification requirements. The article has been updated to reflect this point.

Hepatitis vaccine trial bucks ethics standards, says WHO The study would mean applying a “double standard” to standards of care between the sponsoring countries – Denmark and the US – and the host country.

Thanks as ever to Joshua Abbott for partnering with me in this ongoing investigation. Our full story at BioXconomy, no paywall: www.bioxconomy.com/modalities/g...

Investigations into HIV prevention — including mother-to-infant transmission — established a firm position against allowing two different standards of care for high- and low/middle-income countries.

In our latest piece, we explore how the proposed study hearkens back to precedent set by famous HIV clinical trials in the 1990s.

Last week, the WHO director-general Tedros Adhanom Ghebreyesus minced no words:

"The country can proceed knowing full well that it’s unethical and the scientists can proceed knowing full well that it’s unethical."

Photo of children in colorful clothing in Mandina Mandinga, Gabu Region, Republic of Guinea-Bissau.

The hepatitis B vaccine trial in Guinea-Bissau has come under yet more fire from experts and international bodies — and its future is more uncertain than ever.

Check the thread below for our latest coverage.

Churchill student’s PhD work leads to discovery of new condition - Churchill College Søren Hough completed his PhD at Churchill College in 2023. That work has culminated in an EMBO Molecular Medicine paper that describes a new diagnosis, DIADEM. DIADEM (Developmental delay and Intelle...

I was honored to be profiled by Churchill College regarding our recent @embomolmed.org paper out of the Jackson lab (www.stevejacksonlab.org) on MAEA, DNA repair/replication, and a new diagnosis, DIADEM.

(I tried to aim my answers at a general audience.)

www.chu.cam.ac.uk/news-and-eve...

AdvanCell and 48Hour Discovery partner on radiotherapeutics The partnership will focus on a novel lead-based therapy for gastrointestinal cancer.

AdvanCell and 48Hour Discovery team up to develop a ²¹²Pb-based peptide radiotherapeutic for gastrointestinal cancer, combining cutting-edge discovery and alpha therapy expertise. #Biotech #Innovation

Read below:

www.bioprocessintl.com/deal-making/...

"But what we know is that the critical need for the country is really hepatitis, as you remember when the minister himself was there, he was highlighting that one out of five in the population is affected by hepatitis."

In short, no updates (yet) from their end.

At today's press conference, AfricaCDC senior official Yap Boum II said: "We are still monitoring the conversation with the countries, and so far there has been nothing really new on that site. So as soon as we have something new, we will let you know - maybe during the next [briefing]."

Grateful to @cambiochem.bsky.social for spotlighting my PhD work, recently published in @embomolmed.org.

We're really proud of this international collaboration between a wide range of researchers and clinicians. Thanks to everyone involved!

www.bioc.cam.ac.uk/news/embo-mo...

Thanks, Millie!

A vaccine trial in Guinea-Bissau comes under intense scrutiny An RFK, Jr.-linked vaccine trial in Guinea-Bissau is not cancelled, despite reports.

An excellent piece of investigative journalism by our talented editors Joshua Abbott and Søren Hough. Opens an interesting conversation regarding the ethics of clinical trials conducted overseas, and the implications of anti-vaccination sentiments.

Read below:

www.bioxconomy.com/modalities/b...

A vaccine trial in Guinea-Bissau comes under intense scrutiny An RFK, Jr.-linked vaccine trial in Guinea-Bissau is not cancelled, despite reports.

Trump administration - Babies as ‘guinea pigs’: A vaccine trial in Guinea-Bissau comes under intense scrutiny.

An RFK, Jr.-linked vaccine trial in Guinea-Bissau is not cancelled, despite reports.

I would add that the official protocol for the study (www.bandim.org/wp-content/u...) lists SDU as its sponsor.

From their site, "Bandim Health Project is a collaboration between the Guinean Ministry of Health and University of Southern Denmark."

A vaccine trial in Guinea-Bissau comes under intense scrutiny An RFK, Jr.-linked vaccine trial in Guinea-Bissau is not cancelled, despite reports.

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"Reiss is also skeptical of the reasoning for the trial put forward in the protocol. She said the argument rests on a key anti-vaccination plank – the supposed danger of aluminum adjuvants. Benn and Schaltz-Buchholzer cite “concerns […] regarding providing an aluminum-containing vaccine..

I agree that ethics approval is a significant concern. We're also still in the process of reaching out to various authorities in Denmark to see what approvals the team may or may not have applied for, in compliance with Helsinki. Troubling!