On Mar. 8, 2021, ImmunityBio and NantKwest announced that the first cohorts of their South Africa and U.S. COVID-19 vaccine trials had received their initial doses of the company’s T-cell-based COVID-19 vaccine candidate, hAd5. This candidate was unique in targeting both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus.

In the three trials, the hAd5 vaccine candidate is being administered in a subcutaneous, oral, or sublingual formulation. The Phase I trial in Cape Town, South Africa is using subcutaneous administration and nine participants have been dosed to date. It is expected to be followed by sublingual delivery and room temperature-stable oral capsule trials. The two U.S. Phase Ib trials are studying a combination of subcutaneous/sublingual and subcutaneous/oral formulations; six participants have been dosed in each trial to date. In total, 140 participants will be enrolled in the South African and U.S. trials.

The Phase I trial is being conducted at the Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa) Khayelitsha Clinical Research Site. Participants will receive two subcutaneous injections of the vaccine candidate 21 days apart and will be closely monitored for safety outcomes and immune responses generated. The evaluation of this novel COVID-19 vaccine, designed to be formulated in a room-temperature-stable capsule and can be administered sublingually, is a critical step for South Africa in the fight against the pandemic. The capsule and sublingual formulations protocol will be evaluated in a follow-on trial.