The first-in-human, proof-of-concept, open label, dose escalation, dose-finding, ongoing trial has been designed to assess the vaccine in up to 24 healthy subjects.
It will evaluate two concentrations of the anti-SARS-CoV-2 vaccine’s tolerability, safety, and immunogenicity given orally as a two-dose schedule with a gap of 21 days.
Based on the preliminary Phase I data, in the majority of subjects dosed, significant antibody response was observed as measured by multiple immune response markers to VLP vaccine antigens.
No safety issues were reported, including mild symptoms.
The first cohort of the trial comprised 12 eligible subjects, who were administered one capsule containing the low dose on first day and a second oral dose on day 21.
This trial will include another 12 subjects who will receive a high dose and a second dose on days one and 21, respectively.
To evaluate the safety, tolerability, and antibody titers, the trial subjects will be monitored for 24 weeks after giving the initial dose, following which an end of trial visit will take place.
Oramed Pharmaceuticals CEO Nadav Kidron said: “We’re very encouraged by this initial data, which indicates that our platform can be safely and successfully used to orally deliver protein-based vaccines.”
The oral vaccine candidate of Oravax for Covid-19 is designed using Premas Biotech’s Crypt Platform as a triple antigen VLP vaccine that acts on the Spike, Membrane, and Envelope surface proteins of the SARS-CoV-2 virus.
In July this year, Oramed Pharmaceuticals enroled and randomised over 50% of subjects in its second Phase III ORA-D-013-2 global multicentre trial of oral insulin capsule, ORMD-0801, for type 2 diabetes.