California firms launch trials of COVID shot they hope will protect against South African variant

South Africa has approved clinical trials of a COVID-19 vaccine candidate designed to protect against variants of the coronavirus.

Last week, the country’s Health Products Regulatory Authority (SAHPRA) granted authorization to two biotechnology companies based in California, ImmunityBio and NantKwest, to begin Phase I clinical trials.

Their candidate, called the hAd5 T-cell vaccine, targets two parts of the virus: the spike (S) protein and the nucleocapsid (N) protein,

The S protein is on the outside of the virus and is more prone to mutations while the N protein is more stable and less likely to mutate.

Researchers hope the inoculation will help protect against variants like the ones that emerged in the UK, South Africa and Brazil, which have been shown to lower the efficacy of vaccines compared to the original strains.   

‘The nucleocapsid protein appears to be much more stable and therefore has a lower risk of developing mutations that could risk vaccine failure,’ co-investigator Dr Graeme Meintjes, a professor of medicine at the University of Cape Town. told Quartz Africa. 

The trial’s first phase, which is also being tested in the U.S., will look at whether vaccine is safe and effective and whether or not it elicits an immune response. 

Volunteers will be given two injections administered 21 days apart and eventually compared to those who received a placebo.

Like the Johnson & Johnson’s vaccine, the ImmunityBio shot combines genetic material from the new virus with the genes of the adenovirus – which causes the common cold – to induce an immune response.  

ImmunityBio says its vaccine can be stored at standard refrigerators temperatures, which are different than those produced by Pfizer-BioNTech and Moderna.

Scientists are also testing versions of the jab that could be stored at room temperature or taken orally, which would make the vaccine easier to distribute, reported Quartz Africa.  

The trial will also examine whether the vaccine stimulates the production of T-cells and B-cells, types of white blood cells that attack against invaders and are key to immunity.

In a statement chairman and CEO of ImmunityBio Dr Patrick Soon-Shiong – a billionaire biotech entrepreneur who is also owner of the Los Angeles Times – said he is very excited about the trials.  

‘We are excited about the potential of our COVID-19 vaccine candidate and the issues it could solve globally,’ he said in a statement.

‘Unlike antibody-based vaccines, T-cell-based vaccines kill the infected cell, preventing virus replication, and could provide long-term immune memory to recipients. 

‘Pursuing a vaccine that does not rely solely on targeting the S protein where the mutations are occurring is of critical importance as multiple variants of the SARS-CoV-2 virus have appeared globally, with concentrated outbreaks beginning in South Africa.’ 

Also participating in the trial is Dr Tulio de Oliveira, a geneticist at the Nelson Mandela School of Medicine in Durban, who identified the mutation known as B1.351. 

‘Our scientists…have discovered that patients who recovered from the first wave of COVID-19 may no longer be protected from the new local SARS-CoV-2 variants,’ he said. 

‘We are hopeful that by teaming up with ImmunityBio, the now rampant 501Y.V2 variant in our country can soon be eliminated and protected against for good.’

Currently, 44.5 million people – 13.4 percent of the U.S. population – have received at least dose and 19.8 million – six percent – have received two doses.