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Published on: September 20, 2019
Characterization of Individuals Interested in Participating in a Phase I SARS-CoV-2 Vaccine Trial
Parichehr Shamsrizi1,2,3, Frederik Johannes Kramer1,2,4, Marylyn Martina Addo1,2,3
1Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.
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.
Insights
High interest in the MVA-SARS-2-S vaccine trial was observed, with many volunteers citing elevated COVID-19 risk factors. Media coverage significantly influenced rapid volunteer response for this critical SARS-CoV-2 vaccine development.
Area of Science:
- Vaccinology
- Infectious Diseases
- Clinical Trial Management
Background:
- Developing an effective SARS-CoV-2 vaccine is a global health priority.
- Clinical trial recruitment challenges can lead to study discontinuation.
- Understanding volunteer motivations is crucial for successful vaccine trials.
Purpose of the Study:
- To assess volunteer interest and demographics for a Phase I SARS-CoV-2 vaccine trial (MVA-SARS-2-S).
- To identify factors influencing rapid volunteer recruitment.
- To gain insights into participant motivations for vaccine trial involvement.
Main Methods:
- Analysis of emails received from interested volunteers between May 20-September 30, 2020.
- Assessment of volunteer demographics, including age, sex, and pre-existing conditions.
- Evaluation of volunteer risk factors, such as healthcare worker status and contact frequency.
Main Results:
- 2541 individuals expressed interest in the MVA-SARS-2-S vaccine trial.
- 62% of volunteers responded within three days of the initial media announcement.
- Participants had a mean age of 61, with significant numbers reporting pre-conditions or high-risk occupations.
Conclusions:
- A substantial number of volunteers were motivated by perceived elevated risk for COVID-19.
- Media attention and the perceived threat of the disease appear to be key drivers for participation.
- Findings offer insights to improve future clinical trial recruitment strategies for vaccines.
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