Procedures
toxicity
ADVERSE EVENTS, RVF, EVENTS, BLOOD
The ChAdOx1 RVF vaccine (formerly known as ChAdOx1 GnGc) has been described previously and was manufactured by Advent Srl in accordance with current Good Manufacturing Practices as described in the Investigational Medicinal Product Dossier.Following vaccination, participants attended a series of follow-up visits at the following nominal timepoints: day 2, 7, 14, 28, 56 and 84. Participants also completed a daily online symptom diary for 28 days following vaccination. Solicited adverse events were collected for 7 days and unsolicited adverse events (all other events not defined as solicited) for 28 days post-vaccination. Occurrence of serious adverse events was assessed at all follow up visits. Clinical laboratory blood tests including full blood count, liver function, renal function and electrolytes were performed at day 0 (immediately prior to vaccination), day 2, day 7 and day 28. Laboratory adverse events were graded by use of toxicity tables, which were adapted from the United States Food and Drug Administration toxicity grading scale. Unsolicited adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 24·0 and assessed by investigators for causality with ChAdOx1 RVF. Blood samples for immunology assays were taken on day 0 and at days 7, 14, 28, 56 and 84. The schedule of timepoints for all immunogenicity measures was specified in a laboratory analysis plan prior to the enrolment of the first participant. Four timepoint related protocol deviations occurred relating to attendance of visits outside of the planned schedule including 3 participants attending the day 28 visit between 6 and 11 days later and 1 participant attending the day 56 timepoint 17 days earlier than scheduled.Electronic data capture and clinical data management were carried out using OpenClinica open-source software, version 4·0.