COVID-19 Vaccine Update: Novavax starts phase I/II clinical trials, here's all you need to know about the vaccine
Named NVX‑CoV2373, Novavax’s vaccine is created using recombinant protein nanoparticle technology.
On May 25, the America-based vaccine development company Novavax announced in a press release that it had begun the phase I/II trial of the company’s COVID-19 vaccine candidate in Australia.
Named NVX‑CoV2373, Novavax’s vaccine is created using recombinant protein nanoparticle technology - a genetic-engineering technology wherein the specific parts of the DNA of a virus can be incorporated into a vector. A vector is a DNA molecule that can carry a piece of foreign DNA in it and can be used to transfer, and express specific DNA sequences to a host cell. When introduced into a person’s body these DNA sequences would produce specific antigens (foreign substances against which our body mounts an immune response). Our body would then produce antibodies against the antigen as if the virus was really there, hence, providing us immunity against the disease.
This technology is reportedly already being used against viruses that cause Hepatitis B and shingles.
NVX‑CoV2373 expresses an antigen derived from the spike protein of SARS-CoV-2, the causative agent of COVID-19. Along with the antigen, the vaccine also contains the Matrix‑M adjuvant. An adjuvant is an agent that can increase the immune response a vaccine produces. Matrix‑M adjuvant is made of Quillaja saponins, cholesterol and phospholipid. Quillaja is the South American soap tree.
On February 26, Novavax announced that it is working on various recombinant protein candidates for COVID-19. NVX‑CoV2373 was officially announced as their candidate on April 8.
In a news release on April 8, Novavax revealed that NVX‑CoV2373 had shown to be highly immunogenic (ability to provoke an immune response) in animal models. The vaccine had successfully produced a high titer (measure for antibodies) of neutralising antibodies against the receptor-binding domain (the part that actually binds with ACE-2 receptors in the human body) of the spike protein of SARS-CoV-2 after a single dose of the vaccine. The second dose increased the titer about 8-fold.
In their April 8 press release, Novavax had declared that they are going to begin clinical trials of their vaccine candidate by May. Recruitment for the trials began on April 30 and is still ongoing.
Right now, only the phase I trial has begun. It will be a random, observer-blind placebo-controlled trial that will evaluate the safety and immunogenicity of the vaccine.
A total of 131 volunteers in the age group of 18-59 years will be enrolled in the phase 1 trial at two different sites in Australia. The trial will test two different doses (5 and 25 mcg) with and without the adjuvant. The placebo group will get a saline solution.
The preliminary results of the phase 1 trial are expected in July 2020, after which the phase II trials will begin in multiple countries, including the USA.
The trial is being funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
Stanley C. Erck, President and CEO of Novavax said in yesterday’s press release that administering the vaccine to the first candidates in the phase 1 trials is a significant achievement. These trials are another step towards fulfilling the world’s need for a vaccine against COVID-19.
For more information, read our article on COVID-19 vaccine candidates.
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