NIH: Phase 3 trial of Novavax investigational COVID-19 vaccine opens

The Clinical Center on the campus of the National Institutes of Health, in Bethesda, Md., is an internationally renowned hospital where patients are also research subjects. The Muslim Times has the latest and the best about vaccines

Source: NIH

NIH- and BARDA-funded trial will enroll up to 30,000 volunteers.

The Phase 3 trial of another investigational coronavirus disease 2019 (COVID-19) vaccine has begun enrolling adult volunteers. The randomized, placebo-controlled trial will enroll approximately 30,000 people at approximately 115 sites in the United States and Mexico. It will evaluate the safety and efficacy of NVX-CoV2373, a vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland. Novavax is leading the trial as the regulatory sponsor. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, are funding the trial.

“Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts on the part of government, academia, industry and the community,” said NIAID Director Anthony S. Fauci, M.D. “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.”

The trial is being conducted in collaboration with Operation Warp Speed(link is external) (OWS), a multi-agency collaboration overseen by HHS and the Department of Defense that aims to accelerate development, manufacture and distribution of medical countermeasures for COVID-19. Some of the U.S. trial sites participating are part of the NIAID-supported COVID-19 Prevention Network(link is external) (CoVPN). The CoVPN includes existing NIAID-supported clinical research networks with infectious disease expertise and was designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for preventing COVID-19.

Volunteers will be asked to give informed consent prior to their participation in the trial. They will be grouped into two cohorts: individuals 18 through 64 years old and those aged 65 and older, with a goal of enrolling at least 25% of all volunteers who are 65 years old or older. Trial organizers also are emphasizing recruitment of people who are at higher risk of severe COVID-19 disease, including those who are Black (including African Americans), Native American, or of Latino or Hispanic ethnicity, and people who have underlying health conditions such as obesity, chronic kidney disease or diabetes.

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

After providing a baseline nasopharyngeal and blood sample, participants will be assigned at random to receive an intramuscular injection of either the investigational vaccine or a saline placebo. Randomization will be in a 2:1 ratio with two volunteers receiving the investigational vaccine for each one who receives placebo. Because the trial is blinded, neither investigators nor participants will know who is receiving the candidate vaccine. A second injection will be administered 21 days after the first.

Participants will be followed closely for potential vaccine side effects and will be asked to provide blood samples at specified time points after each injection and during the following two years. Scientists will analyze the blood samples to detect and quantify immune responses to SARS-CoV-2, the virus that causes COVID-19. Of note, specialized assays will be used to distinguish between immunity as a result of natural infection and vaccine-induced immunity. The trial’s primary endpoint is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second injection relative to placebo.

Novavax’s investigational vaccine, NVX-CoV2373, is made from a stabilized form of the coronavirus spike protein using the company’s recombinant protein nanoparticle technology. The purified protein antigens in the vaccine cannot replicate and cannot cause COVID-19. The vaccine also contains a proprietary adjuvant, MatrixM™. Adjuvants are additives that enhance desired immune system responses to vaccine. NVX-CoV2373 is administered in liquid form and can be stored, handled and distributed at above-freezing temperatures (35° to 46°F). A single vaccine dose contains 5 micrograms (mcg) of protein and 50 mcg of adjuvant.

In animal tests, NVX-CoV2373 vaccination produced antibodies that blocked the coronavirus spike protein from binding to the cell surface receptors targeted by the virus, preventing viral infection. In results(link is external) of a Phase 1 clinical trial published in the New England Journal of Medicine, NVX-CoV2373 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 a Phase 2b trial in South Africa, now fully enrolled with 4,422 volunteers, and data from a Phase 1/2 continuation trial in the United States and Australia is expected as early as first quarter 2021. Novavax also recently completed enrollment of more than 15,000 volunteers in a Phase 3 trial of the candidate vaccine in the United Kingdom, which is also testing two injections of 5 mcg of protein and 50 mcg of Matrix-M adjuvant administered 21 days apart.

An independent Data and Safety Monitoring Board (DSMB) will provide oversight to ensure the safe and ethical conduct of the study. All Phase 3 clinical trials of candidate vaccines supported through OWS are overseen by a common DSMB developed in consultation with the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative.

Adults who are interested in joining this study can visit is external) is external) or and search identifier NCT04611802


Categories: Vaccine

6 replies

  1. India announced Tuesday morning that it has detected the new Covid-19 variant in six passengers who have returned from the United Kingdom, according to the Ministry of Health and Family Welfare.

    All six patients have been isolated and anyone who came in contact with them is currently under quarantine.

    “All these persons have been kept in single room isolation in designated health care facilities by respective state governments,” the health ministry said in a news release.
    “Their close contacts have also been put under quarantine. Comprehensive contact tracing has been initiated for co-travellers, family contacts and others. Genome sequencing on other specimens is going on.
    Last week, the Indian government suspended all flights to and from the UK till the end of December.

    State and Federal authorities have been tracking about 33,000 passengers who traveled to India from the UK between November 25 and December 22. Of those, 114 have tested positive for Covid-19. Samples from all positive patients are being genome sequenced for variants.

  2. Biotech company Novavax — which announced the launch of a phase 3 trial of its Covid-19 vaccine in the US on Monday — confirmed it is also testing its vaccine against the UK strain of coronavirus that appears to transmit more easily.

    “We are actively testing sera against the new UK strain,” the company said in a statement Monday, adding that “results will take several weeks.”
    This will involve taking blood from trial participants who received the vaccine and checking to see if their antibodies neutralize the UK strain in the lab.

    Novavax joins other pharmaceutical companies, including Pfizer and Moderna, that are also testing their vaccines against this strain — which has become widespread in the United Kingdom and has appeared in many other countries. The variant appears to be more transmissible, but there’s no indication it causes more severe disease.

    The statement noted there have been other coronavirus variants, and the company believes its vaccine will create an “immune response that covers these sequence variants and will be protective.”

  3. Novavax Inc. said Monday it is starting a new clinical trial of up to 30,000 people in the U.S. and Mexico to test whether its experimental Covid-19 vaccine safely protects people from the disease.

    Novavax’s shot will become the fifth Covid-19 vaccine to enter final-stage testing in the U.S., and if results are positive it could receive authorization sometime during 2021. Public-health officials say that despite the introduction of the first two Covid-19 vaccines in the U.S., additional vaccines will be needed to meet demand and control the pandemic.

    “We’ve come this far, this fast, but we need to get to the finish line,” said Francis S. Collins, director of the National Institutes of Health, which is helping to fund the Novavax study. “That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease.”

    The company didn’t say when it expects to generate results from the new study, but it will likely be spring at the earliest. Studies of the first two vaccines from Pfizer Inc. and Moderna Inc. took nearly four months for results to become available.

  4. Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico
    Dec 28, 2020 at 9:20 AM EST
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    PREVENT-19 will assess the efficacy, safety and immunogenicity of NVX-CoV2373 in the prevention of COVID-19
    Trial to enroll up to 30,000 volunteers across approximately 115 sites in the U.S. and Mexico
    Two-thirds of enrollees to receive active vaccine
    GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

    “With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” said Stanley C. Erck, president and chief executive officer, Novavax. “We thank our colleagues and partners who continue to work with us to urgently advance our commercial-scale manufacturing processes, and we are grateful for the hard work and assistance from Operation Warp Speed, the U.S. FDA and the government of Mexico on this program.”

    NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C and is shipped in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels.

    PREVENT-19 is being conducted with support from Operation Warp Speed partners, including the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response. BARDA is also providing up to $1.6 billion under a Department of Defense agreement (identifier MCDC OTA agreement number W15QKN-16-9-1002).

    The company is also currently conducting a large pivotal Phase 3 clinical study in the United Kingdom (U.K.), a Phase 2b safety and efficacy study in South Africa, and an ongoing Phase1/2 trial in the U.S. and Australia. Data from these trials are expected as soon as early first quarter 2021, although timing depends on transmission rates in the regions.

    About the PREVENT-19 Phase 3 Study

    PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.

    The trial’s primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

    Two thirds of the participants will be assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one third of the trial participants will receive placebo. Trial sites were selected in locations where transmission rates are currently high, to accelerate the accumulation of positive cases that could show efficacy.

    The primary efficacy analysis is event-driven, based on the number of participants with symptomatic mild, moderate or severe COVID-19 disease. Participants will be followed for 24 months following the second injection.

  5. Novavax (NASDAQ:NVAX) ranked as the top-performing coronavirus stock of 2020 with a staggering gain of close to 3,000%. Can the biotech stock deliver another sizzling performance this year? Don’t be surprised if it happens.

    The company expects to report results from a late-stage study of COVID-19 vaccine candidate NVX-CoV2373 conducted in the U.K. in early 2021. Novavax initiated another late-stage study in the U.S. and Mexico last week. Look for results from this study sometime in the second quarter.

    If all goes well with these studies, billions of dollars will pour into Novavax’s coffers. The company has deals in place with several countries (including the U.S., U.K., Australia, Canada, and New Zealand) to supply close to 300 million doses of NVX-CoV2373.

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