Defining the interval for monitoring potential adverse events following immunization (AEFIs) after receipt of live viral vectored vaccines.

ABSTRACT: Live viral vectors that express heterologous antigens of the target pathogen are being investigated in the development of novel vaccines against serious infectious agents like HIV and Ebola. As some live recombinant vectored vaccines may be replication-competent, a key challenge is defining the length of time for monitoring potential adverse events following immunization (AEFI) in clinical trials and epidemiologic studies. This time period must be chosen with care and based on considerations of pre-clinical and clinical trials data, biological plausibility and practical feasibility. The available options include: (1) adapting from the current relevant regulatory guidelines; (2) convening a panel of experts to review the evidence from a systematic literature search to narrow down a list of

SUBMITTER: Kochhar S 

PROVIDER: S-EPMC6535369 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature