Controversial Hepatitis B Vaccine Trial in Guinea-Bissau Suspended Amid Ethical Concerns

A clinical trial in Guinea-Bissau, co-funded by the U.S. Centers for Disease Control and Prevention (CDC), to examine the broader health effects of a birth dose of the hepatitis B vaccine has been put on hold. The suspension follows mounting criticism regarding the study’s ethical basis and potential conflicts of interest, prompting a review by the World Health Organization (WHO).

Ethical Concerns and Trial Design

The trial, led by researchers at the Bandim Health Project, aimed to investigate “non-specific” effects of the hepatitis B vaccine, including potential impacts on skin conditions and neurodevelopment. The study design involved randomizing 14,000 newborns to receive either a birth dose of the hepatitis B vaccine – a practice recommended by the WHO to prevent mother-to-child transmission – or to receive the vaccine at six weeks of age. This approach sparked criticism, as it meant half of the newborns would be left unprotected during a critical period of vulnerability.

The WHO expressed “significant concerns regarding the study’s scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants.” CIDRAP

Conflicts of Interest and Approval Process

Concerns have also been raised about the approval process within Guinea-Bissau. Reports indicate irregularities, including the continued use of a former ethics board president’s signature on approval documents after his resignation. A senior researcher at the Bandim Health Project served on the ethics committee reviewing the trial, despite recusal policies. Sources described the committee’s operation as resembling “a friends club,” suggesting a blurred line between the research organization and the ethics review process. Nature

According to Nature, the university has contacted both the relevant Regional Committee on Health Research Ethics and the National Committee on Health Research Ethics to determine whether they could consider the matter, but both bodies have stated that, under Danish law, they do not have the mandate to assess a project that has been approved by a local ethics committee in another country.

Response from Stakeholders

The University of Southern Denmark, which oversees the Bandim Health Project, has placed the study on hold pending further clarification of its ethical basis and a review by the WHO Research Ethics Review Committee.

The CDC, initially defending the trial as a “gold-standard, independent study,” has since adopted a more cautious stance, stating it is looking into whether the trial can still receive proper approval in Guinea-Bissau. CIDRAP

Experts, including Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, have argued that withholding the birth dose is unethical given the vaccine’s established efficacy and safety profile. CIDRAP

Background on Hepatitis B in Guinea-Bissau

Guinea-Bissau has a high prevalence of chronic hepatitis B infection, affecting nearly 1 in 5 people. Without vaccination, up to 90% of babies exposed to the virus at birth will contract chronic hepatitis B, and 15% to 25% will die prematurely from liver cancer or liver failure. The country is planning to introduce universal hepatitis B vaccination for newborns in 2027/28. Bandim Health Project

Looking Ahead

The suspension of this trial highlights the critical importance of rigorous ethical oversight in international research, particularly when involving vulnerable populations. The WHO’s review will be crucial in determining whether the study can proceed in a manner that protects the rights and well-being of participants. The Bandim Health Project is also conducting research into the overall health effects of vaccines, building on more than 40 years of research. Bandim Health Project