Clinical trial for COVID -19
Official title Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
ClinicalTrials.gov ID: NCT07287137
What this study is testing
What is Pfizer-BioNTech mRNA COVID-19 vaccine?
an investigational vaccine being studied for prevention of COVID-19 is designed to deliver mRNA that instructs cells to produce the SARS‑CoV‑2 spike protein, prompting an immune response
Also referred to as BNT162b2, Comirnaty.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at the immune response and side‑effects of the Novavax and Pfizer‑BioNTech COVID‑19 vaccines.
- What's involved
- Participants will receive either the Novavax or the Pfizer‑BioNTech COVID‑19 vaccine and will be followed over time to record their immune response and any reactions.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79. Healthy volunteers may be eligible.
You may be able to join if
- 18-79 years old
- Age \> 65 years old
- Physical inactivity (defined as \<150 mins of moderate activity per week or \<75 mins of vigorous activity per week)
- HIV with CD4 count ≥ 500 cells/ul
- Smoker
You likely can't join if
- History of severe allergy or severe adverse reaction such as myocardial inflammation to any component of the mRNA COVID-19 vaccines or the Novavax...
- Received a COVID-19 vaccine in the last 3 months.
- Tested positive for COVID-19 in the past 3 months. \- Presence of fever, cough, chills, shortness of breath, runny nose, or sore throat today on day...
- Active use of immune modulating medications. \- Defined as active use of chronic immune modulating medications such as systemic corticosteroids at a...
- Diagnosed with immunocompromised stated. \- Defined as: presence of a disease that is actively causing severe immune suppression or history of prior...
- Diabetes with the most recent HgbA1C ≥ 7.5.
See the full eligibility criteria
- 18-79 years old
- Age \> 65 years old
- Physical inactivity (defined as \<150 mins of moderate activity per week or \<75 mins of vigorous activity per week)
- HIV with CD4 count ≥ 500 cells/ul
- Smoker
- Asthma
- Depression or other mood disorder
- Schizophrenia spectrum disorder
- Cerebrovascular disease
- Heart failure
- Coronary artery disease
- Cardiomyopathy
- Pulmonary embolism
- Pulmonary hypertension
- Cystic fibrosis
- Bronchiectasis
- Chronic obstructive pulmonary disease
- Interstitial Lung Disease
- Stage I or II chronic kidney disease (Stage 1 defined as normal GFR (\> 90) but with other signs of kidney damage such as proteinuria or hematuria) (Stage 2 defined as having a glomerular filtration rate (GFR) of 60 -...
- Gestational diabetes
- Type 1 diabetes with most recent HgbA1C \< 7.5%
- Type 2 diabetes with most recent HgbA1C \< 7.5%
- Liver disease without cirrhosis and with liver enzyme levels (AST and ALT) no greater than three times the upper limit of normal
- Smoking
- Military Health System beneficiary and DEERS eligible
- Willing to be assigned by chance to receive either the Novavax COVID-19 vaccine or the mRNA Pfizer-BioNTech COVID-19 vaccine
- Will be able to return for a clinic visit in approximately 30 days, Day 150, and be able to follow-up online for the next 9 months.
- History of severe allergy or severe adverse reaction such as myocardial inflammation to any component of the mRNA COVID-19 vaccines or the Novavax recombinant COVID-19 vaccine
- Received a COVID-19 vaccine in the last 3 months.
- Tested positive for COVID-19 in the past 3 months. \- Presence of fever, cough, chills, shortness of breath, runny nose, or sore throat today on day of screening/enrollment visit.
- Active use of immune modulating medications. \- Defined as active use of chronic immune modulating medications such as systemic corticosteroids at a dose equivalence of 20 mg prednisone or greater daily for over one...
- Diagnosed with immunocompromised stated. \- Defined as: presence of a disease that is actively causing severe immune suppression or history of prior splenectomy (removal of spleen).
- Diabetes with the most recent HgbA1C ≥ 7.5.
- Stage III or greater chronic kidney disease \- Defined as estimated glomerular filtration rate \< 60 ml/min/1.73m2)
- Obesity with a BMI ≥ 40
- HIV with a CD4 cell count \< 500 cells/ul
- History of solid organ or bone marrow transplant.
- Active malignancy \- Defined as any cancer that is currently being treated or has shown evidence of progression within the past year.
- Chronic liver disease with compensated or decompensated cirrhosis, or liver enzyme levels (AST or ALT) greater than three times the upper limit of normal.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.