Considerations for unblinding individual study participants during vaccine trials

Neal Halsey; Stephen Evans; Mathuram Santosham; Adam Hacker; Kathryn M. Edwards; Rebecca E. Chandler; Matthew Z. Dudley; Cornelia L. Dekker; Seif Al-Abri; Narendra Arora; Jim Buttery; Alex Dodoo; Juhani Eskola; Ulrich Heininger; Youngmee Jee; Najwa Khuri; Stephen Obaro; Walt Orenstein; Punnee Pitisuttithum; Marco Safadi; Cynthia G. Whitney; Steve Black; other members of the SPEAC meta-DSMB

doi:10.1016/j.vaccine.2023.04.033

Considerations for unblinding individual study participants during vaccine trials

Neal Halsey
, Stephen Evans
, Mathuram Santosham
, Adam Hacker
, Kathryn M. Edwards
, Rebecca E. Chandler
, Matthew Z. Dudley
, Cornelia L. Dekker
, Seif Al-Abri
, Narendra Arora
, Jim Buttery
, Alex Dodoo
, Juhani Eskola
, Ulrich Heininger
, Youngmee Jee
, Najwa Khuri
, Stephen Obaro
, Walt Orenstein
, Punnee Pitisuttithum
, Marco Safadi

Cynthia G. Whitney, Steve Black, other members of the SPEAC meta-DSMB

Research output: Contribution to journal › Article › Other › peer-review

1 Citation (Scopus)

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.

Original language	English
Pages (from-to)	3399-3402
Number of pages	4
Journal	Vaccine
Volume	41
Issue number	22
DOIs	https://doi.org/10.1016/j.vaccine.2023.04.033
Publication status	Published - 22 May 2023
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Adverse events
Regulatory guidance
Unblinding
Vaccine
Vaccine safety
Vaccine trials

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10.1016/j.vaccine.2023.04.033Licence: CC BY-NC

Cite this

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., ... other members of the SPEAC meta-DSMB (2023). Considerations for unblinding individual study participants during vaccine trials. Vaccine, 41(22), 3399-3402. https://doi.org/10.1016/j.vaccine.2023.04.033

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title = "Considerations for unblinding individual study participants during vaccine trials",

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.",

keywords = "Adverse events, Regulatory guidance, Unblinding, Vaccine, Vaccine safety, Vaccine trials",

author = "Neal Halsey and Stephen Evans and Mathuram Santosham and Adam Hacker and Edwards, \{Kathryn M.\} and Chandler, \{Rebecca E.\} and Dudley, \{Matthew Z.\} and Dekker, \{Cornelia L.\} and Seif Al-Abri and Narendra Arora and Jim Buttery and Alex Dodoo and Juhani Eskola and Ulrich Heininger and Youngmee Jee and Najwa Khuri and Stephen Obaro and Walt Orenstein and Punnee Pitisuttithum and Marco Safadi and Whitney, \{Cynthia G.\} and Steve Black and \{other members of the SPEAC meta-DSMB\}",

note = "Funding Information: The authors appreciate the time and expertise provided by Jacqueline Miller, William Gruber, John Perez, Andrew Pollard, Richard Whitley, Larry Corey, Sue Ann Costa Clemens, and the administrative assistance of Maria Pia Aristimu{\~n}o. Task Force for Global Health with a grant from Coalition for Epidemic Preparedness Innovations. Publisher Copyright: {\textcopyright} 2023 The Author(s)",

year = "2023",

month = may,

day = "22",

doi = "10.1016/j.vaccine.2023.04.033",

language = "English",

volume = "41",

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Halsey, N, Evans, S, Santosham, M, Hacker, A, Edwards, KM, Chandler, RE, Dudley, MZ, Dekker, CL, 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, CG, Black, S & other members of the SPEAC meta-DSMB 2023, 'Considerations for unblinding individual study participants during vaccine trials', Vaccine, vol. 41, no. 22, pp. 3399-3402. https://doi.org/10.1016/j.vaccine.2023.04.033

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AU - Halsey, Neal

AU - Evans, Stephen

AU - Santosham, Mathuram

AU - Hacker, Adam

AU - Edwards, Kathryn M.

AU - Chandler, Rebecca E.

AU - Dudley, Matthew Z.

AU - Dekker, Cornelia L.

AU - Al-Abri, Seif

AU - Arora, Narendra

AU - Buttery, Jim

AU - Dodoo, Alex

AU - Eskola, Juhani

AU - Heininger, Ulrich

AU - Jee, Youngmee

AU - Khuri, Najwa

AU - Obaro, Stephen

AU - Orenstein, Walt

AU - Pitisuttithum, Punnee

AU - Safadi, Marco

AU - Whitney, Cynthia G.

AU - Black, Steve

AU - other members of the SPEAC meta-DSMB

N1 - Funding Information: The authors appreciate the time and expertise provided by Jacqueline Miller, William Gruber, John Perez, Andrew Pollard, Richard Whitley, Larry Corey, Sue Ann Costa Clemens, and the administrative assistance of Maria Pia Aristimuño. Task Force for Global Health with a grant from Coalition for Epidemic Preparedness Innovations. Publisher Copyright: © 2023 The Author(s)

PY - 2023/5/22

Y1 - 2023/5/22

N2 - 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.

AB - 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.

KW - Adverse events

KW - Regulatory guidance

KW - Unblinding

KW - Vaccine

KW - Vaccine safety

KW - Vaccine trials

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DO - 10.1016/j.vaccine.2023.04.033

M3 - Article

C2 - 37121805

AN - SCOPUS:85153933944

SN - 0264-410X

VL - 41

SP - 3399

EP - 3402

JO - Vaccine

JF - Vaccine

IS - 22

ER -

Considerations for unblinding individual study participants during vaccine trials

Abstract

UN SDGs

Keywords

Access to Document

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