A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine
Condition: SARS-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19
Intervention: Moderna COVID-19 Vaccine
Intervention description: A lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available). It is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 1923.0
Sex: All
Minimum age: 18 Years
Maximum age: 29 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: SARS-CoV-2

Summary:

      The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent
      potential transmission in individuals immunized with the Moderna COVID-19 vaccine.
    

Eligibility criteria:

        Inclusion criteria for Main cohort, Vaccine Declined Group General and Demographic Criteria

          -  Age of 18 through 29 years.

          -  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 Main cohort, 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.

        Inclusion criteria for Prospective Close Contact (PCC) cohort

          -  Age of 18 years or older, at the time of signing the informed consent.

          -  Willing and able to provide informed consent.

          -  Expected to be in frequent close physical proximity with Main Cohort participant
             during the study.

          -  Willing to share results of SARS-CoV-2 testing.

          -  Access to device and internet for completion of study procedures

        Inclusion criteria for Case-ascertained Close Contact (CACC) cohort

          -  Age of 18 years or older, at the time of signing the informed consent.

          -  Willing and able to provide informed consent.

          -  Access to device and internet for completion of study procedures.

          -  Willing to share results of SARS-CoV-2 testing.

          -  Had close contact with Main Cohort participant with known PCR-confirmed SARS-CoV-2
             infection (eg, index case). Close contacts will have had exposure to the index
             participant, generally within 72 hours of an index diagnosis, and may include
             individuals that meet any of the following guidelines:

        Prolonged close physical proximity with Main Cohort participant within a
        residence/vehicle/enclosed space without maintaining social distance,

        Medical staff, first responders, or other care persons who cared for the index case without
        appropriate personal protective equipment.

        Further information on the definition of close contact can be found in the CoVPN 3006 Study
        Specific Procedures (SSP).