We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App





Novavax COVID-19 Vaccine Elicits Wild-Type Virus Neutralizing Antibody Responses in 100% of Participants in Phase 1/2 Trial

By HospiMedica International staff writers
Posted on 06 Aug 2020
Print article
Image: Novavax COVID-19 Vaccine Elicits Wild-Type Virus Neutralizing Antibody Responses in 100% of Participants in Phase 1/2 Trial (Photo courtesy of Novavax, Inc.)
Image: Novavax COVID-19 Vaccine Elicits Wild-Type Virus Neutralizing Antibody Responses in 100% of Participants in Phase 1/2 Trial (Photo courtesy of Novavax, Inc.)
Novavax, Inc. (Gaithersburg, MD, USA) has announced positive Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID‑19 vaccine with and without Matrix‑M adjuvant in healthy adults 18-59 years of age.

NVX‑CoV2373, the company’s recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Overall, the vaccine was well-tolerated and reactogenicity events were generally mild. Following Dose 1, tenderness and pain were the most frequent local symptoms and systemic events were individually less frequent with headache, fatigue and myalgia being reported most commonly. As expected, following Dose 2, greater reactogenicity was reported, although the majority of symptoms were reported as ≤ Grade 1. The average duration of events was < 2 days. Unsolicited adverse events were collected through 28 days after Dose 2. There were no severe (Grade 3) unsolicited adverse events, and the vast majority of adverse events were mild and deemed not related to vaccination. No serious adverse events (SAEs) were reported and safety follow-up continues.

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional. The adjuvant was dose-sparing, with the lower 5 µg dose of NVX‑CoV2373 performing comparably with the 25 µg dose. Cellular immune responses were measured in a subset of participants, and NVX‑CoV2373 induced antigen-specific polyfunctional CD4+ T cell responses with a strong bias toward the Th1 phenotype (IFN-g, IL-2, and TNF-a). NVX-CoV2373 is stable and will allow handling in a liquid formulation that can be stored at 2°C to 8°C, allowing for successful cold chain management with existing infrastructure.

“The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well‑tolerated COVID-19 vaccine with a robust immunogenicity profile,” said Gregory M. Glenn, M.D., President, Research and Development at Novavax. “Using a stringent wild-type virus assay performed by investigators at the University of Maryland School of Medicine, NVX‑CoV2373 elicited neutralizing antibody titers greater than those observed in a pool of COVID‑19 patients with clinically significant disease.”

Related Links:
Novavax, Inc.

Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
Gold Member
POC Blood Gas Analyzer
Stat Profile Prime Plus
Silver Member
Wireless Mobile ECG Recorder
NR-1207-3/NR-1207-E
New
Computed Tomography (CT) Scanner
Aquilion Serve SP

Print article

Channels

Critical Care

view channel
Image: Researchers have developed a novel risk score for cardiovascular complications after bone marrow transplant (Photo courtesy of 123RF)

Novel Tool Predicts Cardiovascular Risks after Bone Marrow Transplantation

Every year, thousands of people undergo bone marrow transplants to potentially cure serious diseases like leukemia, lymphoma, and immune deficiency disorders. While these transplants can be lifesaving,... Read more

Surgical Techniques

view channel
Image: The Early Bird Bleed Monitoring System provides visual and audible indicators of the onset and progression of bleeding events (Photo courtesy of Saranas)

Novel Technology Monitors and Lowers Bleeding Complications in Patients Undergoing Heart Procedures

Bleeding complications at the femoral access site can significantly hamper recovery, affecting the success of procedures, patient satisfaction, and overall healthcare costs. It is crucial for surgeons... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The new eye-safe laser technology can diagnose traumatic brain injury (Photo courtesy of 123RF)

Novel Diagnostic Hand-Held Device Detects Known Biomarkers for Traumatic Brain Injury

The growing need for prompt and efficient diagnosis of traumatic brain injury (TBI), a major cause of mortality globally, has spurred the development of innovative diagnostic technologies.... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.