A Study of an Experimental COVID-19 Vaccine by Novavax, Sponsored by NIAID
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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years and older
Gender:
Any
Healthy Volunteers: Yes
Keywords: COVID-19, coronavirus, vaccine, vaccine study, Novavax, SARS-CoV-2
Type: Drug Study
Target:
250 Participants
Investigator:
Description
This is a study of an experimental COVID-19 vaccine by Novavax, sponsored by NIAID (the National Institute of Allergy and Infectious Diseases). The name of the investigational vaccine is “SARS-CoV-2 rS with Matrix-M1™ Adjuvant”. The vaccine may help the body to fight against coronavirus infection (COVID-19). There is currently no approved vaccine to prevent or act against the coronavirus.
This study requires

The study has 8-10 required visits and will last about 26 months. The study has a Screening, Injection, & COVID-19 Surveillance and Follow-up period. The first four visits will occur within the first 3 months. After this, the visits are approximately one visit every 6 months for the rest of the study. You will receive either the study vaccine or a placebo. A placebo does not contain any active ingredient.

The procedures in this study include:

  • two injections given 3 weeks apart into your upper arm

  • swabs of your nose (nasal swabs) if you develop symptoms of COVID-19

  • keeping records of your body temperature and symptoms of COVID-19 (if any)

  • blood tests

There are other procedures done and other health information collected during this study. The study team will check to see if you qualify to take part in the study. Qualified participants will receive detailed information about the study. This will include a list of study-related tests and procedures.

Who can participate

Each participant must meet the following criteria to take part in this study:

  1. Adults ≥ 18 years of age at screening who are at a higher risk of exposure to and infection with coronavirus
  2. In generally good health
  3. Agree to not take part in another coronavirus prevention study during this study

Participants meeting any of the following criteria cannot take part in this study:

  1. Unstable acute or chronic illness. Criteria for unstable medical conditions include: Major change in prescribed medication for a chronic condition in the past 2 months, or Current undiagnosed illness that could lead to diagnosis of a new condition
  2. Participation in another investigational study within 45 days before first study vaccination
  3. Have already contracted COVID-19
  4. Received influenza vaccination or any other vaccine within 4 days before or within 7 days after either study vaccination.
  5. Active cancer (malignancy) on therapy within 1 year before first study vaccination
  6. Current participation in any other COVID-19 prevention clinical trial.

There are other requirements to participate in the study. The study team will determine if you are eligible to take part in this study. They will review the full eligibility criteria with you.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.

RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
Participants will receive $100 for each completed vaccination visit, $70 for each other clinical visit, and $260 for each completed year of the Daily eDiary. Participants will receive $5 for completion of the Reactogenicity eDiary, and will also receive $70 for each unscheduled visit they complete. Participants may also be reimbursed for expenses including travel, standard data rates or other expenses incurred as part of the study participation.
Resources
UC Davis IRB: 1664573
ClinicalTrials.gov: NCT04368988
Schedule
Study duration and period
You will be in this study for about 2 years and 2 months. You will have about 8-10 study visits.
Recruitment period
From Oct. 28, 2020
Location
CTSC Clinical Research Center
2221 Stockton Boulevard
Suite D
Sacramento, CA 95817
Research Topic
Conditions:
  • COVID-19
  • coronavirus
  • vaccine
  • vaccine study
  • SARS-CoV-2
  • healthy volunteer

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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