Considerations for unblinding individual study participants during vaccine trials
Issued Date
2023-01-01
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-85153933944
Journal Title
Vaccine
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine (2023)
Suggested Citation
Halsey N., Evans S., Santosham M., Hacker A., Edwards K.M., Chandler R.E., Dudley M.Z., Dekker C.L., Al-Abri S., Arora N., Buttery J., Dodoo A., Eskola J., Heininger U., Jee Y., Khuri N., Obaro S., Orenstein W., Pitisuttithum P., Safadi M., Whitney C.G., Black S. Considerations for unblinding individual study participants during vaccine trials. Vaccine (2023). doi:10.1016/j.vaccine.2023.04.033 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/82306
Title
Considerations for unblinding individual study participants during vaccine trials
Author's Affiliation
Institut Pasteur Korea
The University of Jordan
Stanford University School of Medicine
London School of Hygiene & Tropical Medicine
University of Melbourne
Universitat Basel
University of Ghana
University of Nebraska Medical Center
Mahidol University
Johns Hopkins Bloomberg School of Public Health
Vanderbilt University
Emory University
Executive Director of The INCLEN Trust International
Coalition for Epidemic Preparedness Innovations
Global Vaccine Data Network
Directorate General for Disease Surveillance and Control
National Institute for Health
São Paulo Medical School
The University of Jordan
Stanford University School of Medicine
London School of Hygiene & Tropical Medicine
University of Melbourne
Universitat Basel
University of Ghana
University of Nebraska Medical Center
Mahidol University
Johns Hopkins Bloomberg School of Public Health
Vanderbilt University
Emory University
Executive Director of The INCLEN Trust International
Coalition for Epidemic Preparedness Innovations
Global Vaccine Data Network
Directorate General for Disease Surveillance and Control
National Institute for Health
São Paulo Medical School
Other Contributor(s)
Abstract
Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or “pseudo unblinding,” in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization.