Clinical Studies

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Pfizer & BioNTech’s mRNA Vaccine Study Begins

BNT162b2 is an investigational mRNA vaccine being developed by Pfizer and BioNTech to help prevent COVID-19, the disease caused by the SARS-CoV-2 virus. The purpose of the study is to test how well the investigational vaccine works at preventing COVID-19 disease and evaluate whether it is safe for adults and adolescents. BNT162b2 contains a small part of the genetic code for the SARS-CoV-2 spike protein. BNT162b2 does not contain any live virus. It cannot give you SARS-CoV-2 infection, nor will you get COVID-19.

Visit ClinicalTrials.gov - NCT04368728 for additional details.

The ENSEMBLE Study with Janssen’s Ad26.COV2.S Investigational Vaccine

The Ad26.COV2.S investigational vaccine is being developed to prevent or lessen the severity of COVID-19, the disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). The Ad26.COV2.S investigational vaccine includes bits of genetic material copied from the spikes of the SARS-CoV-2 virus. The goal is for the body to be immunized against COVID-19. The investigational vaccine does not contain the actual virus and cannot cause COVID-19. The ENSEMBLE study aims to test Janssen’s investigational vaccine in many different populations across the globe.

Visit ClinicalTrials.gov - NCT04505722 for additional details.

AstraZeneca Study of AZD1222 Begins

AZD1222 is an investigational vaccine being developed by AstraZeneca to prevent COVID-19, the disease caused by the SARS-CoV-2 virus.

The vaccine is based on a weakened version of a common cold (adenovirus) virus. The adenovirus vaccine has been changed so that it can’t replicate inside your body. It presents part of the COVID-19 spike protein to the body so that an immune response can be made to it. The purpose of the study is to test how well the investigational vaccine works at preventing COVID-19 disease and how safe it is.

Visit ClinicalTrials.gov - NCT04516746 for additional details.

Regeneron’s 10933 and 10987 Antibodies, the REGN-COV2 Study

REGN-COV-2 is testing a combination of two antibodies called REGN10933 and REGN10987 to see whether they are able to prevent acquisition of SARS-CoV-2. This study will enroll approximately 2,000 adults in the United States who are living in the same household as a person who has recently tested positive for SARS-CoV-2. This will include about 1,700 participants who test SARS-CoV-2 negative at enrollment and about 300 participants who have a positive SARS-CoV-2 test result but do not have any COVID-19 symptoms.

The REGN10933 and REGN10987 antibodies are designed to bind to SARS-CoV-2 and prevent the virus from entering healthy cells. The antibodies were made in a lab by the pharmaceutical company Regeneron. REGN10933 and REGN10987 cannot give you SARS-CoV-2, nor will they make you sick with COVID-19.

Learn more about the study and the antibodies used:

Eli Lilly’s LY3819253 Antibody, the BLAZE-2 Study

BLAZE-2 is testing the LY3819253 antibody. It will be enrolling staff and residents in skilled nursing and assisted living facilities with a high risk of exposure to SARS-CoV-2. The study questions are:

  • Does the antibody prevent the acquisition of SARS-CoV-2?
  • Does the antibody help to prevent the development of more severe COVID-19, or does it reduce the symptoms?

The study will be conducted in the United States with up to 2,400 participants. LY3819253 is designed to bind to SARS‑CoV-2 and prevent the virus from entering healthy cells. LY3819253 was developed in a lab by the pharmaceutical company Eli Lilly. LY3819253 cannot give you SARS-CoV-2, nor will it make you sick with COVID-19.

Visit blaze2study.com or ClinicalTrials.gov - NCT04497987 for additional details. You may also call the BLAZE-2 Call Center at 718-210-9713 from 9 a.m. to 5:30 p.m. Eastern Time Monday through Friday.

Moderna’s mRNA-1273 vaccine, The COVE Study

The mRNA-1273 vaccine is being developed to prevent COVID-19. The purpose of this study is to test Moderna’s vaccine candidate to see if it can prevent illness if people are exposed to the SARS-CoV-2 virus in their everyday lives. The mRNA-1273 vaccine is not made from the SARS-CoV-2 virus. It is made from messenger ribonucleic acid (mRNA), a genetic code that tells cells how to make protein, which helps the body’s immune system make antibodies to fight the virus. The vaccine cannot cause infection or make someone sick with COVID-19.

Visit ClinicalTrials.gov - NCT04470427 for additional details.

This section will be updated as we have more information about additional studies. Please check back.


What Is a Clinical Study?

Interventions that have shown promise in the laboratory and then in animal models subsequently move on to research studies in people, also known as clinical studies. The COVID-19 Prevention Network (CoVPN) will be doing studies to find safe and effective vaccines and monoclonal antibodies for the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), which is the virus that causes coronavirus disease 2019 (COVID-19).

These vaccines and antibodies cannot cause SARS-CoV-2 infection or COVID-19 illness. They do not contain any live or killed virus. Participants in these studies may be exposed to the virus in their everyday lives, but they will not be exposed to the virus as part of the study (known as “challenge studies.”) These are studies of preventive vaccines that we hope will keep people healthy.

What Are the Different Stages of Clinical Studies to Test Preventive Vaccines and Antibodies Against COVID-19?

Clincal Trials Phase 1

Phase 1 Clinical Studies

Phase 1 studies test the safety of a product. This means seeing if there are side effects, and whether the human body can tolerate the vaccine or antibody. The experimental product is often compared to a group that receives a placebo, a substance such as sterile saltwater that has no active ingredients. These studies are conducted with a small group of people (usually less than 100) and typically last 12 to 18 months.

Clincal Trials Phase 2

Phase 2 Clinical Studies

Phase 2 studies look at questions such as the maximum tolerated dose, the optimal schedule for giving the product (how many doses, and at what time intervals), and whether the immune system is having the desired responses. These responses can include the production of antibodies, the production of T cells, and other immune system markers. These studies are conducted with a medium-size population of volunteers (usually a few hundred to 1000) and the studies can last up to 2 years.

Clincal Trials Phase 2b

Phase 2b Clinical Studies

Phase 2b studies are a way to get an early look at whether the product is effective at preventing infection or disease. They are sometimes known as Proof of Concept or Test of Concept studies. A group of several thousand people who are at increased risk for infection or disease are enrolled, and the studies can last about 2-5 years. Based on the data from these studies, researchers can see whether the results seem favorable, supporting moving ahead to Phase 3. If the results are less favorable, it means that researchers can redirect their efforts and save the expenses of large Phase 3 studies.

Clincal Trials Phase 3

Phase 3 Clinical Studies

Phase 3 studies are where researchers can ask the questions, “Does this product prevent new infections? Or if people do become infected, does the product help them control the infection so that it doesn’t become severe disease?” These studies involve many thousands of people, usually including some participants who are at increased risk for infection.

Clincal Trials Phase 4

Phase 4 Clinical Studies

Phase 4 studies may take place after a product has been found to be effective in some populations, and are utilized to gather additional information about safety and effectiveness by testing the product in additional populations such as children or pregnant women. They are sometimes known as bridging studies, or post-licensure studies. These studies may be conducted in anyone seeking a prevention option from their physician.

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