The first volunteer in a Phase I clinical trial of an oral COVID-19 vaccine developed by an Israeli-American company has been screened and enrolled, according to Oravax Medical, a subsidiary of Oramed Pharmaceuticals.
The trial is taking place in South Africa.
Oramed Pharmaceuticals, a clinical-stage pharmaceutical company, is based on technology developed by Hadassah-University Medical Center and run by Israeli CEO Nadav Kidron.
Oravax developed a novel oral virus-like particle (VLP) COVID-19 vaccine based on the Oramed’s “POD” oral delivery technology that can be used to orally administer a number of protein-based therapies, which would otherwise be delivered by injection.
The vaccine was developed in collaboration with an Indian company, Premas.
The plan is to enroll 24 participants into the Phase I trial – all people who have neither received a COVID-19 vaccine developed by another company nor contracted the virus.
Volunteers will receive one dose of the vaccine at the beginning of their participation and another dose three weeks later. The trial’s endpoints will include safety and tolerability, as well as efficacy by measuring the presence of an immunogenic response.
“We expect to rapidly complete this study and hope to advance into pivotal trials for emergency use approval in countries where our oral VLP vaccine would have the greatest impact,” said Kidron. “South Africa is a great location for the Phase I study, as it is currently experiencing a surge in COVID cases and has struggled to obtain sufficient vaccines.
“It is our firm belief that an oral vaccine which eliminates syringes and eases distribution and administration, can significantly help increase vaccination rates for South Africa and similar countries,” he said.
Experts believe that the Omicron variant that is burning across the world emerged in South Africa. To date, only around 23% of the country is jabbed.
The Oravax vaccine candidate targets three structural proteins of the novel coronavirus, as opposed to the single spike protein targeted by the current Moderna and Pfizer vaccines, Kidron said.
As such, “this vaccine should be much more resistant to COVID-19 variants,” he said. “Even if the virus gets through one line, there is a second line, and if through the second line, there is a third.”