Bandim Health Project

Revised hepatitis B birth-dose study receives ethical approval in Guinea-Bissau and Denmark

The revised HBV-NSE study has received ethical approval from Guinea-Bissau’s national ethics committee (CNEPS) and the Research Ethics Committee at the University of Southern Denmark (SDU). CNEPS issued its approval of the revised protocol on 14 July 2026, and SDU’s REC approved the project and accompanying participant information and consent documents on 30 September 2026.

The revised design includes maternal hepatitis B screening, immediate birth-dose vaccination for babies of mothers who test positive, a saline placebo, and a separate voluntary offer of HIV testing. In addition, our team will offer BCG, OPV and hepatitis B vaccines to all neonates whose mother declined to participate. The study still awaits the remaining governmental authorisation in Guinea-Bissau before it can begin.

Here you can find the revised protocol and the Ethical approvals, read questions and answers to the revised study, and find links to earlier posts describing the original protocol.

Find the new revised and approved HBV-NSE Trial Protocol here.

Find the Letter of Approval from Comité Nacional de Ética em Pesquisa na Saúde, Guinea-Bissau here. 

Find the Letter of Approval from the SDU Research Ethics Committee here.

Questions and answers

This update builds on our earlier explanation and the subsequent discussion of the ethical questions surrounding the trial and describes the principal changes since the original submission.

What is the study investigating?

The protective effect of hepatitis B vaccination against hepatitis B infection is established. The study addresses a different question: whether adding a hepatitis B birth dose to BCG and oral polio vaccine affects babies’ overall health. The primary outcome combines deaths from any cause and non-fatal hospital admissions with infection during the first six weeks of life.

What has changed since the first submission?

The principal changes are:

  • Maternal hepatitis B screening before randomisation. Mothers will be offered HBsAg testing with separate informed consent. Babies of mothers who are known to have hepatitis B, test positive, or whose status cannot be determined will not be randomised and will be offered the birth-dose vaccine promptly. BCG, oral polio vaccine and hepatitis B vaccine is also offered to babies whose mother/guardian does not wish to participate in the study.
  • A saline placebo in the comparison group. Instead of receiving no additional injection, this group will receive sterile saline alongside BCG and oral polio vaccine. Parents, follow-up teams and the trial statistician will be blinded to allocation, while the vaccination team will not.
  • Voluntary HIV testing. Mothers will also be offered HIV-1/HIV-2 testing with separate consent, confidential counselling and referral for confirmatory testing and care where indicated. Declining HIV testing will not prevent trial participation.

The overall research aim remains the same, but the randomised comparison is now restricted to babies of mothers testing HBsAg-negative.

Will babies in the comparison group receive routine hepatitis B vaccination?

Yes. Both groups receive BCG and oral polio vaccine at birth and follow the routine childhood vaccination schedule, including hepatitis B-containing vaccines at 6, 10 and 14 weeks. The trial therefore evaluates an additional birth dose, not hepatitis B vaccination versus no hepatitis B vaccination.

How will the study be monitored?

An independent Data and Safety Monitoring Board will oversee trial progress and review safety information under predefined procedures. The protocol provides for blinded outcome assessment and analysis, and significant protocol changes require ethical review before implementation.

Does ethical approval mean the study can start immediately?

No. Ethical approval and governmental authorisation are separate steps. The Ministry of Public Health has requested a technical assessment by Guinea-Bissau’s vaccination committee, and the remaining national authorisation process must be completed before recruitment begins. Under the protocol, recruitment will end if universal hepatitis B birth-dose vaccination is introduced nationally.

Links to earlier posts describing the original protocol: