Characterization of Individuals Interested in Participating in a Phase I SARS-CoV-2 Vaccine Trial

Abstract

The development of an effective vaccine against SARS-CoV-2 marks one of the highest priorities during the ongoing pandemic. However, recruitment of participants for clinical trials can be challenging, and recruitment failure is among the most common reasons for discontinuation in clinical trials. From 20 May 2020, public announcements about a planned phase I trial of the vaccine candidate MVA-SARS-2-S against SARS-CoV-2 began, and interested individuals started contacting the study team via designated e-mail. All emails received from these individuals between 20 May 2020–30 September 2020 were assessed. Of the 2541 interested volunteers, 62% contacted the study team within three days after the first media announcement. The average age was 61 years (range 16–100), 48% of volunteers were female and 52% male. A total of 274, 186, and 53 individuals, respectively, reported medical pre-conditions, were health-care workers, or had frequent inter-person contacts. In conclusion, we report a high number of volunteers, with a considerable percentage stating factors for an elevated risk to acquire COVID-19 or develop severe disease. Factors such as media coverage and the perception of a disease as an acute threat may influence the individual’s choice to volunteer for a vaccine trial. Our data provide first important insights to better understand reasons to participate in such trials to facilitate trial implementation and recruitment.

A national platform for Covid-19 vaccine studies recruitment in France: Covireivac volunteer’s characteristics

“… 10 A French study and a German study conducted during the Covid-19 pandemic highlighted that volunteers with comorbidities were more likely to participate in Covid-19 vaccine trials. 11 , 18 This finding may be explained by the pandemic context, as Covid-19 was perceived as an acute threat in persons with comorbidities. 19 …”

COVID-19 Vaccines: Where Did We Stand at the End of 2023?

“…Additionally, immunization of C57NL/6 mice was well tolerated and induced S-specific humoral and cellular immune responses [ 141 ]. In clinical settings, the recruitment for phase I evaluation of MVA-COV2-S has been described [ 142 ]. Currently, a phase II trial for MVA-COV2-S (MVA-SARS-2-S) is in progress [ 87 ].…”

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“…Additionally, immunization of C57NL/6 mice was well tolerated and induced S-specific humoral and cellular immune responses [114]. In clinical settings, the recruitment for phase I evaluation for MVA-COV2-S has been described [115]. Currently, a phase II trial for MVA-COV2-S (MVA-SARS-2-S) is in progress [116].…”