Gene expression signatures after immunisation with a range of live, inactivated and adjuvanted vaccines (BIOVACSAFE protocols 305A, 305B and 305C)

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 (n = 20/21) receiving a single immunisation with a licensed vaccine or saline placebo control. Participants were randomised to receive one of the following vaccines: Protocol 305A: STAMARIL: subcutaneous live yellow fever vaccine given to yellow-fever seronegative participants; VARILRIX: subcutaneous live varicella zoster vaccine given to varicella zoster seropositive participants. Protocol 305B: ENGERIXB1: intramuscular alum-adjuvanted hepatitis B vaccine - priming dose given to hepatitis B naive participants; ENGERIXB3: intramuscular alum-adjuvanted hepatitis B vaccine  - second booster dose given to ENGERIXB1 participants at 6 months. Protocol 305C: AGRIPPAL: intramuscular seasonal influenza vaccine; FLUAD: intramuscular MF59C-adjuvanted seasonal influenza vaccine. PLACEBOAB1C : 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). PLACEBOB3  - control participants in protocol 305B also received a second intramuscular saline injection at 6 months to control the participants receiving ENGERIXB3. Participants were resident in an inpatient unit between days -1 and 5. Pre-immunisation baseline samples were drawn at 08:00H on days -1 and 0. Vaccines were administered at 08:00H on day 0, and further samples collected at 08:00H on days 1,2,3,4 and 5. Participants left the inpatient unit and returned on days 7, 14, 21 and 28 to have samples drawn. All samples were collected into PaxGene tubes.