COVID-19 Prevention Network Study

COVID-19 Prevention Network (CoVPN)

The
UCSD Mother-Child-Adolescent Program provides comprehensive, family centered care of women, children, youth and families. This internationally recognized multidisciplinary specialists provides medical care, clinical research trials, patient education, counseling, case management, peer advocacy, and community education. Its team of investigators is highly experienced in vaccine clinical trials with an emphasis on the prevention of respiratory viral diseases.

Our Mission

To Conduct Phase 3 Efficacy Trials to prevent infection and COVID-19 disease. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of United States government-sponsored COVID-19 vaccines and antibodies for the prevention of COVID-19 disease.

The Studies

The CoVPN expects to open four Phase III vaccine efficacy trials – trials that make sure the vaccine works – in 2020, with the potential for additional trials to follow. Each study is anticipated to enroll roughly 30,000 people, and participants will either get the vaccine product or a sterile saltwater injection (placebo). Some trials may be conducted only in the United States, while others will enroll global communities.

The first Phase III vaccine trial will be of the Moderna mRNA vaccine that is planned to begin enrollment in the end of July 2020.

The Study Populations

These efficacy trials hope to enroll persons who are at risk for exposure to SARS-CoV-2. This risk could be associated with, but is not limited to:

• Working in an essential job, such as healthcare professions, emergency response personnel, grocery workers, meat-packing plants, etc.;
• Living in densely populated residential environments;
• Living or working in congregated living facilities such as correctional facilities or nursing homes;
• Being a member of a community that has been disproportionately impacted by this pandemic, such as older persons, persons with underlying health conditions, and racial/ethnic groups such as African Americans, Latinx, and Native American populations.

What Study Volunteers Can Expect

Before joining:

• When a potential participant contacts one of the participating study clinics, they will be provided information about the research being done.
• Potential participants will be asked personal questions before coming into the study clinic to help determine their potential for study eligibility. Determining eligibility can include things like asking about their medical history and doing a physical exam. Sometimes a blood sample will be drawn for necessary lab tests.
• Study clinics will provide information about the study to enable people to make an informed decision about whether or not to join the study. Specific details about each study will be provided during the informed consent process.

During the study:

• Most studies require coming into the study clinic for 7 or more visits over 1-2 years.
• Every study involves getting injections or infusions. These are not given at every visit, and the number and schedule will vary with each study.
• Participants will be asked to keep track of how they are feeling using an online diary for about a week following each infusion or injection.
• If a participant becomes infected with COVID-19, the study staff will provide care or direct participants to care.
• Study participants are compensated for their time, travel, and inconvenience while enrolled in the study. 

After the study:

• We may ask if we can contact participants again for another study.
• When the study is complete, the results will be disseminated to all participants and their communities without any identifying information.

Interested in finding out more about joining this study?
Please fill out this short survey below.