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Author Notes:

Corresponding author: Paula M. Frew, The Hope Clinic of the Emory Vaccine Center, 500 Irvin Way, Suite 200, Decatur, GA 30030, USA. Telephone: 404-712-8546. Fax: 404-712-9017. Email: pfrew@emory.edu.

We thank our study volunteers for their time and commitment to this trial.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Research Funding:

This research was supported by the Biostatistics and Clinical Cores of the Emory Center for AIDS Research (P30 AI050409), with additional support from the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR000454.

Keywords:

  • Clinical trials
  • Ethnic minorities
  • Immunization
  • Willingness to participate
  • Women
  • Yellow fever vaccine

Enrollment in YFV Vaccine Trial: An Evaluation of Recruitment Outcomes Associated with a Randomized Controlled Double-Blind Trial of a Live Attenuated Yellow Fever Vaccine

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Journal Title:

Tropical Medicine & Surgery

Volume:

Volume 1, Number 2

Publisher:

, Pages 117-117

Type of Work:

Article | Final Publisher PDF

Abstract:

This investigation evaluated several factors associated with diverse participant enrollment of a clinical trial assessing safety, immunogenicity, and comparative viremia associated with administration of 17-D live, attenuated yellow fever vaccine given alone or in combination with human immune globulin. We obtained baseline participant information (e.g., sociodemographic, medical) and followed recruitment outcomes from 2005 to 2007. Of 355 potential Yellow Fever vaccine study participants, 231 cases were analyzed. Strong interest in study participation was observed among racial and ethnically diverse persons with 36.34% eligible following initial study screening, resulting in 18.75% enrollment. The percentage of white participants increased from 63.66% (prescreened sample) to 81.25% (enrollment group). The regression model was significant with white race as a predictor of enrollment (OR=2.744, 95% CI=1.415-5.320, p=0.003).In addition, persons were more likely to enroll via direct outreach and referral mechanisms compared to mass advertising (OR=2.433, 95% CI=1.102-5.369). The findings indicate that racially diverse populations can be recruited to vaccine clinical trials, yet actual enrollment may not reflect that diversity.

Copyright information:

© 2013 Frew PM, et al.

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