title: 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.
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.
authors.affiliation: Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, USA ; Emory Center for AIDS Research, USA ; The Hope Clinic of the Emory Vaccine Center, USA ; Emory University, Rollins School of Public Health, USA.
authors.forename: Paula M
authors.initials: PM
authors.lastname: Frew
authors.affiliation: The Hope Clinic of the Emory Vaccine Center, USA ; Emory University, Rollins School of Public Health, USA.
authors.forename: Eve T
authors.initials: ET
authors.lastname: Shapiro
authors.affiliation: Emory University, Rollins School of Public Health, USA.
authors.forename: Lu
authors.initials: L
authors.lastname: Lu
authors.affiliation: Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, USA ; The Hope Clinic of the Emory Vaccine Center, USA.
authors.forename: Srilatha
authors.initials: S
authors.lastname: Edupuganti
authors.affiliation: Emory University, Department of Pediatrics, USA.
authors.forename: Harry L
authors.initials: HL
authors.lastname: Keyserling
authors.affiliation: Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, USA ; Emory Center for AIDS Research, USA ; The Hope Clinic of the Emory Vaccine Center, USA.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Mulligan
keywords: Clinical trials; Ethnic minorities; Immunization; Willingness to participate; Women; Yellow fever vaccine