Dr. Andersen at Meridien Research is looking for volunteers to participate in the Novavax 2019nCoV-301 COVID-19 vaccine trial
The COVID-19 pandemic is a global health crisis. Meridien Research is seeking people within our community to volunteer for a clinical trial aimed at developing a safe and effective vaccine for COVID-19.
COVID-19 is having a catastrophic effect on people throughout the country, disrupting and impacting lives across the world. Meridien Research has extensive experience running vaccine trials and will join over 100 research sites to be part of the global search for a safe and effective vaccine to prevent COVID-19.
Novavax’s COVID-19 vaccine trial is going to take place at over 100 clinics and hospitals and is expected to enroll 30,000 adult participants 18 years of age and older. Meridien Research aims to enroll approximately 250 participants from our community into the clinical trial.
We need large numbers of participants, especially people 65 years and older, individuals with underlying medical conditions, and people of racial and ethnic groups that have been impacted in greater numbers by the pandemic including African Americans, Latinx, Asian Americans, Native Americans, and Alaska Natives so that we can be confident about the results.
Two out of three people participating in the clinical trial will receive two intramuscular injections of the vaccine spaced at three weeks apart. The vaccine is designed to prevent COVID-19 by helping create neutralizing antibodies to fight COVID-19 infection. The remaining 1/3 of participants will receive injections of a placebo made of saline (sterile salt water) solution.
All participants will be randomly selected to receive the vaccine or placebo. Participants will be followed for 24 months post-vaccination to monitor their health and safety.
Having some people receive the study vaccine and others receive placebo is the best way to determine whether the vaccine actually works.
The Novavax 2019nCoV-301 clinical trial is evaluating a vaccine that has shown promising results for increasing the body’s immune response to the COVID-19 virus. Clinical trials are used to develop new prevention methods and medical treatments . The research community and study volunteers are critical to demonstrate that a vaccine will reduce the number of outbreaks and deaths caused by COVID-19.
Key recommendations from doctors at Meridien Research include:
• Wash your hands frequently and thoroughly for 20 seconds
• Cover your nose and mouth with a mask and practice social distancing
• Clean frequently-touched surfaces daily using soap and water prior to disinfecting
• Monitor your health daily, as older adults and people with underlying medical conditions may be at increased risk of developing severe complications of COVID-19 disease
To find out more about participating in the Novavax 2019nCOV-301 COVID-19 clinical trial call (813) 563-6009.
Notes for editors:
- In late December 2019, an outbreak of respiratory disease caused by a new coronavirus (2019-nCov) was detected in Wuhan, Hubei province, China. Despite containment efforts since the start of the outbreak, the disease caused by the virus ,which is referred to in public as COVID-19, has spread rapidly with over 214 countries reporting laboratory-confirmed COVID-19 cases as of 10 August 2020.
- On 30 January 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) designated the outbreak as a public health emergency of international concern and subsequently declared a pandemic on 11 March 2020.
- The technical title for this clinical trial is: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants
- The newly described coronavirus’ genetic relationship with the 2002-2003 severe acute respiratory syndrome coronavirus (SARS-CoV) has resulted in adoption of the name SARS-CoV-2, with the associated disease being referred to as COVID-19.
- Novavax, Inc. (Nasdaq: NVAX, herein “Novavax”) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax’ COVID-19 vaccine candidate, NVX-CoV2373, was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to
enhance the immune response and stimulate high levels of neutralizing antibodies
. Further Information about NOVAVAX can be found at: https://novavax.com/our-pipeline#nvx-cov2373 6. Due to the ongoing pandemic, up to date national, regulatory and local Institutional Review Board and public health guidance will be in force regarding protecting trial participants from risk of infection at the clinical trial sites. The clinical trial will use telephone contact, virtual visits via telemedicine and home visits where needed. Patient safety comes first.
For further information, and to arrange interviews, contact:
PI Dr. James Andersen firstname.lastname@example.org
Site Director Colleen Figueroa email@example.com