|Keywords:||COVID-19, Variant, Vaccine, coronavirus, Johnson and Johnson, Pfizer, Booster|
|Type:||Phase 2 Drug Study|
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
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
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.
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
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.