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A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

Recruiting

Study-wide approximately 18,000 healthy volunteers, aged 18 through 29 years, will be followed for up to 5 months after enrollment; up to 6,000 randomized to Immediate Vaccination Group, up to 6,000 randomized to Standard of Care Group, and up to 6,000 non-randomized to Vaccine Declined Group. Participants will self-collect nasal swabs daily in order to capture all incident SARS-CoV-2 infection events over 4 months of follow-up and to capture the full course of viral shedding - from onset of infection to viral clearance - among those with both asymptomatic and symptomatic infection. To minimize participant burden and maximize study efficiency, as many study procedures as possible will be conducted remotely (not requiring an in-person visit) and electronically. Participants diagnosed with SARS-CoV-2 infection will complete daily e-diaries to capture symptoms. The primary objectives are to evaluate the efficacy of Moderna COVID-19 Vaccine against SARS-CoV-2 infection and to evaluate the effect of Moderna COVID-19 Vaccine on peak nasal viral load as a measure of infection and a proxy of infectiousness.

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All
18 Years and over
This study is also accepting healthy volunteers
Inclusion Criteria for Immediate Vaccination and Standard of Care Groups:
• Willingness to be followed for the planned duration of the study.
• Agrees to allow study staff to access school SARS-CoV-2 testing data and outcomes, if applicable.
• Ability and willingness to provide informed consent.
• Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire with demonstration of understanding of all questionnaire items answered incorrectly.
• Willing to be randomized to either immediate vaccination or standard of care group and comply with planned study procedures
• Agrees not to enroll in another study of an investigational research agent until the end of the study.
• Access to device and internet for completion of study procedures. Exclusion Criteria for Immediate Vaccination and Standard of Care Groups:
• Acutely ill 72 hours prior to or at screening. Volunteers meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator.
• Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination.
• Investigational research agents received within 30 days before first vaccination.
• Self-reported known history of SARS-CoV-2 infection.
• Prefers to receive COVID-19 vaccination immediately, (These volunteers to be referred to community resources for vaccination).
• Prior administration of a coronavirus (SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19.
• Immunosuppressive medications received within 168 days before first vaccination (not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses < 60 mg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment).
• Clinically significant medical condition, physical examination findings, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to a process that would affect the immune response (well-controlled human immunodeficiency virus infection is allowed), or any condition specifically listed among the exclusion criteria below.
• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent.
• Bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
• Asplenia: any condition resulting in the absence of a functional spleen.
• History of angioedema or anaphylaxis, including to vaccines or vaccine components (not exclusionary: angioedema or anaphylaxis with known trigger and no episodes within five years.).
• History of generalized urticaria within past five years. Inclusion Criteria for Vaccine Declined Group:
• Ability and willingness to provide informed consent.
• Prefers not to receive COVID-19 vaccine.
• Willingness to be followed for the planned duration of the study.
• Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire with demonstration of understanding of all questionnaire items answered incorrectly.
• Access to device and internet for completion of study procedures. Exclusion criteria for Vaccine Declined Group:
• Prior administration of a coronavirus (SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19 (participation in studies of other investigational research agents allowed).
• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, or a volunteer's ability to give informed consent.

Biological: Moderna COVID-19 Vaccine

COVID-19, Infectious Diseases, Prevention & Wellness, SARS-CoV-2 Infection

SARS-CoV-2

Student Vax Study CoVPN 3006 - studentvaxstudy@umn.edu
Susan Kline, MD
Phase 3
STUDY00012850
NCT04811664
See this study on ClinicalTrials.gov

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