JEFFREY ADELGLASS, M.D., F.A.C.S.
CLINICAL RESEARCH STUDIES
Dallas | ft. worth TEXAS
currently enrolling subjects for
PAID CLINICAL RESEARCH participation
Are you an older adult interested in an investigational updated COVID-19 vaccine?
If you are a medically stable adult (age 50+) and have received 3 or more doses of an mRNA vaccine against COVID-19, please consider the Novavax Peregrine Study.
Who Can Join?
To be eligible for this study, you must be 50 years of age or older and:
- Be in good health at time of participation
- Not have received a COVID-19 vaccine within the past 90 days
What will happen if you take part?
If you agree to take part in this study, you will:
- Attend a study screening visit and return to the study site within two weeks for an enrollment visit (screening and enrollment may take place on the same day).
- Once enrolled, you can expect to:
- Receive the study vaccine injection
- Visit your study site at least 5 times over the course of approximately 7.5 months
- Have at least 1 telephone call with the study team over approximately 7.5 months
- Have blood tests, physical examinations, and other assessments performed on as part of this study
- Download an eDiary smartphone application to answer questions about symptoms and your health or, if needed, be provided with an eDiary device for reporting
- Receive the study vaccine injection
What are my costs to take part in this study?
- You do not have to pay for the study vaccine, study supplies, or tests that are part of the research study.
- You will be compensated for your participation in the Novavax Peregrine Study.
You will be compensated for your time and travel regardless of your immigration status. Transportation to the study site may also be provided, as available. No health insurance is required to participate.
What risks are involved if I decide to participate?
There are possible risks involved with any clinical study. The study doctor will review the risks with you, and you will be closely monitored throughout the study.
Study Overview:
The virus that causes COVID-19 continues to evolve. Novavax is studying their investigational traditional, protein-based (not mRNA) vaccine that is based on a recent variant of the virus. We are conducting a clinical trial to help understand the safety and immune responses to this updated vaccine in older (≥ 50 years of age) adults. If you have already received an mRNA vaccine, you could be eligible to join. The study will be open for enrollment in August and September 2023.This clinical study will help researchers learn:
- If the study vaccine is safe for adults at least 50 years of age
- If the study vaccine is as effective for older adults as it is for young adults
The Novavax Peregrine Study, for adults aged 50 and over, is testing a new, investigational vaccine (also known as a study vaccine) called NVX-CoV2601, designed to prevent COVID-19. The study vaccine is based on the Omicron XBB.1.5 virus strain. The XBB virus lineage was recently recommended by U.S. health authorities as the basis for updated vaccines to be used in the Fall 2023 vaccination season. This trial will test the updated vaccine to make sure that it is safe and produces the desired immune responses in older adults.
The Peregrine Study is focused on people aged 50 and over because older adults may have weakened immune systems, putting them at increased risk for severe COVID-19 outcomes, including hospitalization and death. In studying older populations, scientists have learned from their experiences with flu that higher doses of vaccine may help older people achieve better immune responses to vaccination, and therefore, better protection against flu. For this reason, the Peregrine Study is also testing higher doses of the updated COVID-19 vaccine.
The updated vaccine is being studied as a booster in people previously vaccinated with 3 or more doses of mRNA vaccines. Participants must have received their last mRNA vaccine at least 90 days before being vaccinated in the Peregrine Study.All participants will receive one dose of vaccine. Novavax vaccines in this study contain Matrix-M™ adjuvant, which enhances the immune response to a vaccine.This study will measure the safety and immune responses in approximately 2000 participants. Information from this trial will help researchers better understand vaccine performance. As the world continues to be threatened by the evolving SARS-CoV-2 virus, additional vaccine options would add flexibility to the global COVID-19 vaccination effort.This study is a Phase 2/3 trial sponsored by Novavax, Inc., a US-based pharmaceutical company. This trial is expected to begin in the United States in August 2023. Participant enrollment will occur only in August and September 2023.[i] US Centers for Disease Control and Prevention. https://www.cdc.gov/flu/prevent/qa_fluzone.htm. Accessed June 28, 2023.
Why is this study called “Peregrine”?
Multiple Novavax vaccine trials draw their names from the theme of birds, symbolizing our desire to help people around the world soar beyond COVID-19. The Peregrine falcon is known as a high-flying bird, representing the higher dose levels of vaccine that are being studied in this trial.
To Learn more,
Call: (972) 746-2222
Do you have adolescent-aged children 12 thru 17 years of age?
Visit that Page Here.
Are you 18 and Up, and have never had a Covid-19 Vaccination?