In July Immunity Bio was in South Africa!-
ImmunityBio gets OK from South Africa for dual-antigen T-cell for Covid booster 07/14/21 IBRX ImmunityBio announced authorization from the South Africa Health Products Regulatory Authority, SAHPRA to proceed with the South Africa Sisonke T-Cell Universal Boost trial. The Phase 1/2/3 study, which will begin in Q3 2021, is designed to evaluate hAd5 Spike + Nucleocapsid as a boost for South African healthcare workers previously vaccinated with an S-only vaccine. "With the virus continuing to spread, moving forward with this boost trial is crucial," said Leonard Sender, M.D., Chief Operating Officer of ImmunityBio. "We are encouraged by the preliminary safety findings in our ongoing Phase 1 studies in both the U.S. and South Africa. In addition, our U.S. data show that just a single prime subcutaneous vaccination with our COVID-19 vaccine candidate induces a 10-fold increase in T cell response-equivalent to T cell responses from patients previously infected with SARS-CoV-2. We have also shown that the T-cell responses are maintained against variants, which is critical to providing protection against this ever-changing virus." In the trial, the effect of combining vaccination by two routes of administration-subcutaneous and sublingual -will be assessed. This combination has the potential to deliver protection from the virus with a single jab followed by droplets placed under the tongue. Methods that do not require injection such as SL, intranasal, and oral capsule offer potential advantages depending on the participant's needs or situation. Sublingual administration results in the most rapid absorption, while nasal spray or oral capsule delivery have the potential to provide mucosal immunity, which could reduce both the chance of infection and potential spread of the virus via the respiratory tract. The three non-jab formulations also can be administered without a trained healthcare worker and are easier to transport and store. The SL and nasal routes of administration are also currently being tested in a separate Phase 1 trial in South Africa.
ImmunityBio gets OK from South Africa for dual-antigen T-cell for Covid booster 07/14/21 IBRX ImmunityBio announced authorization from the South Africa Health Products Regulatory Authority, SAHPRA to proceed with the South Africa Sisonke T-Cell Universal Boost trial. The Phase 1/2/3 study, which will begin in Q3 2021, is designed to evaluate hAd5 Spike + Nucleocapsid as a boost for South African healthcare workers previously vaccinated with an S-only vaccine. "With the virus continuing to spread, moving forward with this boost trial is crucial," said Leonard Sender, M.D., Chief Operating Officer of ImmunityBio. "We are encouraged by the preliminary safety findings in our ongoing Phase 1 studies in both the U.S. and South Africa. In addition, our U.S. data show that just a single prime subcutaneous vaccination with our COVID-19 vaccine candidate induces a 10-fold increase in T cell response-equivalent to T cell responses from patients previously infected with SARS-CoV-2. We have also shown that the T-cell responses are maintained against variants, which is critical to providing protection against this ever-changing virus." In the trial, the effect of combining vaccination by two routes of administration-subcutaneous and sublingual -will be assessed. This combination has the potential to deliver protection from the virus with a single jab followed by droplets placed under the tongue. Methods that do not require injection such as SL, intranasal, and oral capsule offer potential advantages depending on the participant's needs or situation. Sublingual administration results in the most rapid absorption, while nasal spray or oral capsule delivery have the potential to provide mucosal immunity, which could reduce both the chance of infection and potential spread of the virus via the respiratory tract. The three non-jab formulations also can be administered without a trained healthcare worker and are easier to transport and store. The SL and nasal routes of administration are also currently being tested in a separate Phase 1 trial in South Africa.
