Researcher Says Guinea-Bissau Trial Will Not Proceed

Frederik Schaltz-Buchholzer, the lead researcher of a proposed newborn hepatitis B vaccine trial, said the study will not proceed in Guinea-Bissau without government approval. His statement followed the health minister’s public rejection of the project as described and concerns over its design and ethical safeguards. Schaltz-Buchholzer said the study had received ethical approvals in Guinea-Bissau and Denmark, but lacked the necessary government authorization. Health Minister Quinhin Nantote said on October 13 that the project had not been authorized in the form publicly described. The two positions address different approval questions: ethical review and government permission. A public protocol dated January 16 proposed enrolling at least 14,500 newborns over two years. One group would receive hepatitis B vaccine at birth alongside BCG and oral polio vaccines; the other would receive those two vaccines without the hepatitis B dose. The primary measure was death from any cause or a first nonfatal hospital admission for infection by 42 days of age. Schaltz-Buchholzer later said the design had changed, but a revised protocol had not been made public. The World Health...