Biomarkers of Vaccine Immunosafety (BioVacSafe) - Study CRC305B

The time course of whole blood gene expression was determined in healthy adult participants residing in an inpatient unit (CRC, University of Surrey, UK) to minimise background environmental variation, who were randomised into three protocols (305A, 305B and 305C) with study groups within each protocol receiving a single immunisation with a licensed vaccine or saline placebo control. In 305B participants were randomised to receive one of the following vaccines: ENGERIX B1: intramuscular alum-adjuvanted hepatitis B vaccine - priming dose given to hepatitis B naive participants; ENGERIX B3: intramuscular alum-adjuvanted hepatitis B vaccine - second booster dose (third dose overall) given to ENGERIX B1 participants at 6 months; ; PLACEBO AB1C : a control group distributed across the three protocols that received immunisation with 0.5 mL normal saline intramuscularly (protocols 305B and 305C) or subcutaneously (305A); PLACEBO B3 - control participants who received a second intramuscular saline injection at 6 months to control the participants receiving ENGERIX B3. Participants were resident in the inpatient unit between days -1 and 5. Vaccines were administered at 08:00H on day 0. For RNA sequence analysis pre-immunisation baseline samples were drawn at 08:00H on day 0, and further samples collected every 4 hours thereafter on days 0, 1 and 2 (hours 0 - 60). Times are accurate to within 15 minutes. All samples were collected into PaxGene tubes. Transcriptomics analysis from Agilent arrays have also been uploaded to GEO (GSE124533) for overlapping time points and for other days.