Join a COVID-19 Variant Vaccine Research Study - Starting Summer 2021, Sign Up Now
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"Thank you for taking the time to consider volunteering to join this COVID-19 Variant Vaccine Research Study"
Age: 18-55
Gender:
Any
Keywords: COVID-19, Variant, Vaccine, coronavirus, Johnson and Johnson, Pfizer, Booster
Type: Phase 2 Drug Study
Target:
50 Participants
Investigator:
Description
Currently, there are three approved COVID-19 vaccines available, but with the recent emergence of virus variants, research continues to evaluate the safety and efficacy of booster shots and modified vaccines targeted to protect against specific variants. Each and every person involved in clinical research plays a powerful role. Volunteering for this study can make a difference as we try to find a potential vaccine to prevent COVID-19 variants and evaluate the need for booster shots.

Every modern vaccine and medicine we have today was studied in hundreds to thousands of people before becoming available to the public. This study hopes to enroll up to 400 people. By volunteering, you will represent people like you – in age, gender, race, ethnicity, and the communities where you live. Involving people from all backgrounds will improve the development of this vaccine for everyone.

This study involves comparing an investigational variant vaccine against an already approved COVID-19 vaccine to help answer the following:
1. Does a combination of different vaccines or a booster shot help us make more antibodies against COVID-19?
2. Does a modified version of an existing vaccine help us generate a more robust immune response against the new South African virus variant?
This study requires

Before enrolling as a participant in the study, the study doctor will answer any questions you may have and will discuss the risks and potential benefits to help you decide if this is the right study for you.

This study is comprised of two cohorts:

  • Cohort One consists of people who have already received the Johnson and Johnson COVID-19 Vaccine within 19-23 days of enrolling in this study. Volunteers in this group will receive:

    • one dose of the previously approved Pfizer COVID-19 Vaccine

      OR

    • one dose of the proposed Pfizer COVID-19 Variant Vaccine.

After about six months, Cohort One will also receive a booster shot of the same vaccine.

  • Cohort Two consists of people who have never received a COVID-19 Vaccine before. Volunteers in this group will receive:

    • two doses of the previously approved Pfizer COVID-19 Vaccine , about 21 days apart

      OR

    • two doses of the proposed Pfizer COVID-19 Variant Vaccine, about 21 days apart.

After about six months, Cohort Two will also receive a booster shot of the same vaccine.

The assignment of the vaccine you receive will be made by a computer and not by the study team. Neither you nor the study doctor will know which Pfizer vaccine you received. There will be no mixing and matching of which vaccine you receive (if you were given the variant vaccine for your first shot, you will also be given the variant vaccine for your second shot and booster shot).

After each injection, you will have additional follow up visits to monitor your health. In total, you will have around nine study visits over the duration of 14 months. At each visit, the study team will ask about your general health and complete study procedures such as a physical exam and blood draws. At visits where you will receive an injection, nasal swabs will be collected, the vaccine will be delivered into the muscle of your upper arm, and you will be monitored for an additional 30 minutes following your injection.

Who can participate
  • Male or female volunteers between the ages of 18 – 55 years

  • In good general health

  • Have received the Johnson and Johnson Vaccine recently OR have never received a COVID-19 Vaccine

Who cannot participate:

  • Volunteers who've had any other COVID-19 vaccine besides Johnson and Johnson

  • Volunteers with a history of COVID-19 infection or a positive COVID-19 test

  • Currently pregnant or planning to become pregnant in the next year

  • Current or previous participation in any other clinical trial for COVID-19

Benefits and risks of participating
Benefits: vaccination with the already approved Pfizer COVID-19 Vaccine has shown to be effective in preventing COVID-19 in the groups of people already studied. However, it is not known yet whether the variant vaccine may reduce the chance of you contracting COVID-19 and its variant forms.

Risks: the study team will discuss the risks associated with taking part in this research study.
Compensation
You will be paid $120 for each completed in-person study visit and $25 for each completed telephone visit.
Resources
Schedule
Study duration and period
You could be in this study for up to 14 months. You will need to visit the study site at least 9 times for planned study visits. There will also be additional telephone visits and reporting of changes in your health to an electronic diary on a mobile phone app.
Recruitment period
From June 1, 2021 to Aug. 1, 2021
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • COVID-19
  • Variants
  • Vaccine
  • Booster

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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