NIH begins clinical trial evaluating second COVID-19 booster shots in adults

The National Institutes of Health (NIH) has begun a phase-II clinical trial evaluating various additional COVID-19 booster in adults in the US. The trial aims to understand if different vaccine regimens—prototype and variant vaccines alone and in combinations—can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH.

“We are looking beyond the Omicron variant to determine the best strategy to protect against future variants. This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover the existing and emerging COVID-19 variants,” Anthony S Fauci, MD and Director, NIAID, said in a statement released by NIH yesterday. “

Vaccine manufacturers have previously studied some variant vaccine candidates, and are currently conducting clinical trials of Omicron-specific vaccines. The COVAIL trial will gather data on the immune responses induced by prototype vaccines and variant vaccine candidates—including bivalent vaccines, which target two SARS-CoV-2 variants—to inform booster shot recommendations, added the statement.

It further mentioned that the first stage of this trial is being conducted in collaboration with Moderna, which is manufacturing the study vaccines that will be administered. The trial will be adapted to enroll more participants to evaluate additional vaccine platforms and variant vaccines from other manufacturers as needed to further inform public health decisions. Participants will be monitored for symptoms and adverse events following vaccination, and will be asked to return to the clinic during set times over the course of 12-14 months to provide blood samples. Investigators will evaluate the samples in the laboratory to measure and characterise immune responses to SARS-CoV-2 strains. Investigators aim to have initial findings available by August 2022.

The study is being conducted in collaboration with academic medical centres across the US, NIAID’s Infectious Diseases Clinical Research Consortium (IDCRC) and the NIAID SARS-CoV-2 Assessment of Viral Evolution (SAVE) Programme, the statement concluded.