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ORIGINAL RESEARCH article

Front. Public Health
Sec. Life-Course Epidemiology and Social Inequalities in Health
Volume 12 - 2024 | doi: 10.3389/fpubh.2024.1411970

Evaluating Enrollment and Representation in COVID-19 and HIV Vaccine Clinical Trials

Provisionally accepted
Daisy Lezo Ramirez Daisy Lezo Ramirez 1Emily Koleske Emily Koleske 1Omolola Ometoruwa Omolola Ometoruwa 1Jun Park Jun Park 1,2Urwah Kanwal Urwah Kanwal 1Nicholas Morreale Nicholas Morreale 1Andres A. Avila Paz Andres A. Avila Paz 1Alexandra Tong Alexandra Tong 1Lindsey R. Baden Lindsey R. Baden 1Amy C. Sherman Amy C. Sherman 1*Stephen Walsh Stephen Walsh 1
  • 1 Brigham and Women's Hospital, Harvard Medical School, Boston, United States
  • 2 University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

The final, formatted version of the article will be published soon.

    Background: Vaccine clinical trials should strive to recruit a racially, socioeconomically, and ethnically diverse range of participants to ensure appropriate representation that matches population characteristics. Yet, full inclusion in research is often limited. Methods: A single-center retrospective study was conducted of adults enrolled at Brigham and Women's Hospital (Boston, MA) between July 2020 -December 2021. Demographic characteristics, including age, race, ethnicity, ZIP code, and sex assigned at birth, were analyzed from both HIV and COVID-19 vaccine trials during the study period, acknowledging the limitations to representation under these parameters. We compared the educational attainment of vaccine trial participants to residents of the Massachusetts metropolitan area, geocoded participants' addresses to their census block group, and linked them to reported median household income levels from publicly available data for 2020. Frequency and quartile analyses were carried out, and spatial analyses were performed using ArcGIS Online web-based mapping software (Esri). Results: A total of 1030 participants from four COVID-19 vaccine trials (n=916 participants) and six HIV vaccine trials (n=114 participants) were included in the analysis. The median age was 49 years (IQR 33-63) and 28 years (IQR 24-34) for the COVID-19 and HIV vaccine trials, respectively. Participants identifying as White were the majority group represented for both the COVID-19 (n=598, 65%) and HIV vaccine trials (n=83, 73%). Fewer than 25% of participants identified as Hispanic or Latin. Based on ZIP code of residence, the median household income for COVID-19 vaccine clinical trial participants (n=846) was 102,088 USD (IQR=81,442-126,094). For HIV vaccine clinical trial participants (n=109), the median household income was 101,266 USD (IQR 75,052 -108,832). Conclusions: We described the characteristics of participants enrolled for HIV and COVID-19 vaccine trials at a single center and found similitude in geographical distribution, median incomes, and proportion of underrepresented individuals between the two types of vaccine candidate trials. Further outreach efforts are needed to ensure the inclusion of individuals from lower educational and socioeconomic brackets. In addition, continued and sustained efforts are necessary to ensure inclusion of individuals from diverse racial and ethnic backgrounds.

    Keywords: (3-10): clinical trial enrollment, diversity, representation, Vaccine, HIV, SARS- CoV- 2

    Received: 08 May 2024; Accepted: 08 Jul 2024.

    Copyright: © 2024 Lezo Ramirez, Koleske, Ometoruwa, Park, Kanwal, Morreale, Avila Paz, Tong, Baden, Sherman and Walsh. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Amy C. Sherman, Brigham and Women's Hospital, Harvard Medical School, Boston, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.