Trial Of Novavax COVID-19 Vaccine Begins In The United States

Phase 3 trial of an investigational COVID-19 vaccine has begun enrolling adult volunteers. The randomized, placebo-controlled trial will be conducted at 115 sites in the United States and Mexico and enroll approximately 30,000 people.

The safety and efficacy of NVX-CoV2373 vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland will be evaluated. Novavax is the regulatory sponsor and is leading the trial.

‘Phase 3 clinical trial of the COVID-19 vaccine NVX-CoV2373 developed by Novavax will begin in the United States and Mexico and enroll 30,000 participants. The vaccine produces antibodies that block COVID-19 protein from binding to the cell surface receptors targeted by the virus thereby prevent viral infection.’

The results of the Phase 1 clinical trial are published in the journal New England Journal of Medicine.

NIAID Director Anthony S. Fauci, M.D. said, "Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts on the part of government, academia, industry and the community. The launch of this study - the fifth investigational COVID-19 vaccine candidate to be tested in a Phase 3 trial in the United States - demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines."

To participate in the trial, volunteers will be asked to give prior informed consent. Two groups will be made: individuals between the age of 18 and 64, and those above the age 65 with a goal of enrolling at least 25% of all volunteers who are 65 years old or older. The trial organizers are emphasizing recruitment of people who are at higher risk of severe COVID-19 disease which includes those who are Black (including African Americans), Native American, or of Latino or Hispanic ethnicity, and also people with comorbid health conditions like obesity, chronic kidney disease or diabetes.

NIH Director Francis S. Collins, M.D., Ph.D. said, "We've come this far, this fast, but we need to get to the finish line. That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease."

COVID-19 Vaccine Clinical Trial

Before administering the vaccine, a baseline nasopharyngeal and blood sample will be collected from the participants. After this, the participants will be assigned randomly to receive an intramuscular injection of either the investigational vaccine or a saline placebo in a ratio 2:1- two volunteers receiving the investigational vaccine for each one who receives placebo.

As the trial is double blinded, neither the participants nor the investigators will know who is receiving the candidate vaccine. After the first injection, the second injection will be administered after 21 days.

Blood samples will be collected at specified time points after each injection and during the following two years. Participants will be followed closely for potential side effects of the vaccine. The blood samples will be analyzed by the scientists to detect and quantify the immune response to SARS-CoV-2. To distinguish between immunity as a result of natural infection and vaccine-induced immunity, specialized assays will be used.

The primary endpoint of the trial is to determine if the NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second injection, when compared to placebo.

NVX-CoV2373 vaccine is made from a stabilized form of the coronavirus spike protein by using recombinant protein nanoparticle technology. As the purified protein antigens in the vaccine cannot replicate, it will not cause COVID-19. The vaccine also contains a proprietary adjuvant, MatrixM� that enhances the desired immune system responses to vaccine.

NVX-CoV2373 is administered in liquid form and can be stored, handled and distributed at temperatures of 35� to 46�F. A single vaccine dose contains 50 mcg of adjuvant and 5 micrograms (mcg) of protein.

The preclinical animal studies show that NVX-CoV2373 vaccine produced antibodies that blocked COVID-19 protein from binding to the cell surface receptors targeted by the virus thereby prevent viral infection.

The phase 1 clinical trial showed that NVX-CoV2373 vaccine was generally well-tolerated and elicited higher levels of antibodies than those seen in blood samples drawn from people who had recovered from clinically significant COVID-19.

NVX-CoV2373 also is being evaluated in South Africa, United States, Australia, and in the United Kingdom.



Source: Medindia