Safety monitoring
Erythema, myalgia, fever, fatigue, erythema, pain, headache, chills, arthralgia
ERYTHEMA, AIDS, ERYTHEMA, LOSS OF APPETITE, INDURATION, INJECTION SITE REACTION
The occurrence of all AEs was recorded through Study Day 84, whereas SAEs and PIMMCs were monitored through Study Day 421. AEs were graded by severity (i.e., Grades 1, 2, or 3) and by relationship to the study injection (i.e., not, possibly, probably, or definitely related) according to definitions provided in the Study Protocol (Local injection site reactions were assessed on the day of the study injection (prior to injection and 60 min after injection) and for 7 days after the study injection by grading pain, erythema, and induration. Solicited systemic reactions were defined as the occurrence of headache, arthralgia, chills, loss of appetite, fever, fatigue, and/or myalgia in the 7 days following each study injection. These symptoms were characterized as Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Memory aid booklets were distributed to each participant to collect local and systemic AE information covering the 7-day period following each study injection. All participants were instructed to record oral temperature and local and general signs and symptoms on individual memory aids on the evening of the day of injection and at approximately the same time daily for the 6 days following study injections. Erythema and induration at the injection site were measured and graded, using the measuring tool provided. Participants were also asked to record any medications taken. The memory aid was brought to the clinic on the scheduled visit 7 days after each injection for review and was collected by the study research staff on Study Days 7 and 63. The memory aid was a tool to help the Investigator and/or designee to engage in conversation with the participant about any AEs that may have occurred following injections.Pulse, oral temperature, respiratory rate, and systolic and diastolic blood pressure were assessed on Study Days 0, 7, 56, 63, and 84. Safety lab tests (hematology and serum chemistry) were performed 7 days after each injection. Changes in vital signs or lab test values meeting Grade 1 or higher grade were recorded as AEs. Urine pregnancy tests were performed in the study clinic using a commercial test. Serology for HIV, HBsAg, HCV, and QuantiFERON-TB Gold was performed at screening. Unscheduled follow-up laboratory tests were done at the discretion of the study clinician. All serology, hematology, and chemistry tests were performed at Quest Diagnostics.This clinical trial utilized a Safety Monitoring Committee (SMC) to monitor subject safety and study halting criteria. The SMC met 1 year after the start of the trial to review the current study status and discuss the safety summary report to date. No significant safety concerns were identified at that point. Therefore, the SMC recommended that the study proceed as planned with no changes.