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COVID-19 Vaccines · Journal article
Human Vaccines & Immunotherapeutics · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This qualitative study reveals that participation in phase 1 COVID-19 vaccine trials was a fluid, continuously reevaluated decision shaped by evolving personal circumstances, pandemic context, and trial adaptations rather than a single enrollment choice. Participants balanced personal benefit, altruism, and circumstances; non-participants prioritized immediate access to approved vaccines. The findings suggest that future trials should anticipate changing contexts and incorporate flexible adaptations to support retention.
Qualitative study using modified grounded theory approach with semi-structured interviews. Healthy eligible individuals enrolled in two phase 1 COVID-19 vaccine trials conducted in Nova Scotia, Canada between 2021 and 2023; 32 who enrolled (trial participants) and 5 who declined enrollment (non-participants).. Intervention: Participation in phase 1 COVID-19 vaccine trial; mid-trial protocol adaptation allowing participants to receive a public health-approved vaccine.. Compared with: Non-enrollment; comparison between trial participants and eligible non-participants regarding decision-making processes. n = 37. Nova Scotia, Canada; two phase 1 COVID-19 vaccine trials.
32 trial participants enrolled; 5 eligible individuals declined enrollment across two phase 1 COVID-19 vaccine trials in Nova Scotia (2021–2023) Core analytic category identified: 'Harmonizing Self and Circumstances Amid a Pandemic'—reflecting continuous reevaluation of motivations and concerns Two overlapping decision-making categories emerged: enrollment decisions balancing personal benefits, circumstances, and altruism; and participation revisiting shaped by PHAV rollout, vaccine mandates, and COVID-19 case counts
Core analytic category identified: 'Harmonizing Self and Circumstances Amid a Pandemic'—reflecting continuous reevaluation of motivations and concerns
These findings highlight that phase 1 vaccine trial participation involves dynamic, context-dependent decision-making. Trial designers and informed consent processes should account for changing circumstances (vaccine availability, mandates, pandemic epidemiology) and consider flexible adaptations to maintain retention and scientific validity.
Qualitative study with small sample examining decision-making processes in phase 1 COVID-19 vaccine trials; provides descriptive insights but lacks quantitative outcome measurement or comparison groups with statistical power.
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Quoted from the source exactly as published.
These findings highlight that phase 1 vaccine trial participation involves dynamic, context-dependent decision-making. Trial designers and informed consent processes should account for changing circumstances (vaccine availability, mandates, pandemic epidemiology) and consider flexible adaptations to maintain retention and scientific validity.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Phase 1 vaccine trials rely on healthy participants who accept uncertainty with limited or no personal health benefit. Why people join and why they stay until trial completion is underexplored. Using a modified grounded theory approach, we examined decision making among eligible individuals who enrolled (trial participants (TPs), n = 32) and those that declined enrollment (non-participants (NPs), n = 5) across two phase 1 COVID-19 vaccine trials conducted during the pandemic (Nova Scotia, Canada; 2021-2023). Semi-structured qualitative interviews were carried out at enrollment or non-enrollment (both groups) and trial completion (TPs only). Transcripts were analyzed with open, focused, and theoretical coding, constant comparison, and memo writing to develop a grounded conceptual account of decision making during a trial. Analysis revealed a core analytic category, Harmonizing Self and Circumstances Amid a Pandemic. Within this broader category, two overlapping and interconnected categories of decision making emerged: Deciding Whether to Enroll, that involved balancing personal benefits, circumstances, and altruistic aims and; Revisiting Participation as Circumstances Changed, shaped by the rollout of Public Health approved vaccines (PHAVs), vaccine mandates, and COVID-19 case counts. A mid-trial protocol adaptation allowing participants to receive a PHAV supported retention until trial completion. NPs prioritized immediate access to a PHAV. Participation in phase 1 vaccine trials was a fluid process rather than a single decision, where motivations, concerns, and priorities were continuously reevaluated with shifting personal, trial, and pandemic circumstances. Future trials should anticipate changing contexts, communicate clearly about informed consent and data integrity when standard-of-care vaccines emerge, and incorporate flexible trial adaptations.
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