Related Experiment Video
Updated: May 14, 2026

Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development
Published on: June 19, 2018
Comprehension of a simplified assent form in a vaccine trial for adolescents
Sonia Lee1, Bill G Kapogiannis, Patricia M Flynn
1Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal Pediatric Infectious Disease Branch, Bethesda, Maryland, USA. leesonia@mail.nih.gov
Introduction:
Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general.
Methods:
Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative.
Results:
123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly.
Conclusions:
Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.
More Related Videos
08:42A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research
Published on: July 31, 2017
13:47Opsono-Adherence Assay to Evaluate Functional Antibodies in Vaccine Development Against Bacillus anthracis and Other Encapsulated Pathogens
Published on: May 19, 2020
Related Concept Videos
Bioequivalence studies: Biowaivers
Vaccinations
Bioavailability Study Design: Healthy Subjects Versus Patients
Vaccines
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...