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July 15, 2021updated 16 Jul 2021 12:53pm

ImmunityBio receives approval to trial Covid-19 vaccine in South Africa

The company intends to offer a booster vaccine by performing or soon initiating three trials in South Africa and two in the US.

ImmunityBio has received approval from the South Africa Health Products Regulatory Authority (SAHPRA) to assess its dual-antigen T-cell vaccine for Covid-19 in Phase I/II/III South Africa Sisonke T-Cell Universal Boost clinical trial.

The trial is scheduled to commence in the third quarter of this year to evaluate the safety, efficacy and immunogenicity of the hAd5 viral-vector vaccine.

It will study the Spike (S) plus Nucleocapsid (N) vaccine as a booster in healthcare workers who previously received an S-only vaccine.

ImmunityBio’s vaccine is designed to target S and N proteins of SARS-CoV-2 to elicit B and T cell memory against these antigens. It also potentially offers durable immunity against the virus.

The vaccine leverages a second-generation hAd5 platform, which could induce immune responses to SARS-CoV-2 in people who are Ad-immune, indicating that individuals can take the vaccine several times, based on the requirement.

Furthermore, the vaccine is available as a subcutaneous (SC) injection, sublingual (SL) drops, intranasal spray and a room-temperature-stable oral capsule, allowing various routes of administration.

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The Phase I/II/III trial is intended to test the ability of the T-cell-based vaccine to prevent breakthrough Covid-19 infections by the Delta variant in healthcare workers who previously received inoculation.

With its vaccine, the company aims to offer more protection and durable immunity to the different SARS-CoV-2 variants and third-wave infections that South Africa and other countries are presently fighting.

A combination of SC and SL formulations of the vaccine will be assessed during the trial to potentially protect with a single shot and subsequent droplets placed under the tongue.

ImmunityBio chief operating officer Leonard Sender said: “We are encouraged by the preliminary safety findings in our ongoing Phase I studies in both the US and South Africa.

“In addition, our US data show that just a single prime subcutaneous vaccination with our Covid-19 vaccine candidate induces a ten-fold increase in T cell response – equivalent to T cell responses from patients previously infected with SARS-CoV-2.”

In April 2021, the company reported initial data from the Phase I trial of the vaccine, which stimulated the T cell reactive to vaccine-delivered S and N protein antigens in healthy subjects.

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