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

Overview

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

Full Title of Study: “A Randomized Controlled Study to Assess SARS CoV-2 Infection, Viral Shedding, and Subsequent Potential Transmission in University Students Immunized With Moderna COVID-19 Vaccine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 22, 2021

Detailed Description

This study will evaluate the efficacy of the Moderna COVID-19 vaccine against SARS-CoV-2 infection, as well as its effect on peak nasal viral load as a measure of infection and a proxy of infectiousness, in university students aged 18-26. Participants will be randomly assigned to 1 of 2 groups. Participants in Group 1 will receive the Moderna COVID-19 vaccine by injection at Months 0 and 1; participants in Group 2 will receive the Moderna COVID-19 vaccine by injection at Months 4 and 5. Additional study visits for Group 1 will occur at Months 2 and 4; for Group 2, at Months 0 and 2. Study visits may include medical history, vaccine injections, blood collection, nasal swab, SARS-CoV-2 screening, COVID-19 symptom check, and questionnaires. In addition to the main study participants, the study will also evaluate infectiousness following close contacts with main study participants. Study procedures for close contacts include questionnaires and blood samples; for those who become SARS-CoV-2 infected, study procedures will also include nasal swabs.

Interventions

  • Biological: Moderna COVID-19 Vaccine
    • 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.

Arms, Groups and Cohorts

  • Experimental: Immediate Vaccination
    • Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml IM into the deltoid muscle on Day 1 and Day 29.
  • Experimental: Delayed Vaccination
    • Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml IM into the deltoid muscle on Day 113 and Day 141.

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of Moderna COVID-19 Vaccine against SARS-CoV-2 infection
    • Time Frame: Measured through Month 4 study visit
    • SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR through Month 1 visit
  • Effect of Moderna COVID-19 Vaccine on peak nasal viral load
    • Time Frame: Measured through Month 4 study visit
    • As a measure of infection and a proxy of infectiousness, peak viral load in nasal samples from participants diagnosed with SARS-CoV-2 infection post Month 1 visit and among participants who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR through Month 1 visit

Secondary Measures

  • Impact of Moderna COVID-19 Vaccine on secondary transmission of SARS-CoV-2 infection
    • Time Frame: Measured through Month 4 study visit
    • Evaluated by the number of secondary transmission events in close-contact cohorts from main study participants who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR after Month 1 visit
  • Efficacy of Moderna COVID-19 Vaccine to prevent serologically confirmed SARS-CoV-2 infection
    • Time Frame: Measured through Month 4 study visit
    • Evaluated by SARS-CoV-2 antibodies to the nucleocapsid protein post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR after Month 1 visit
  • Efficacy of Moderna COVID-19 Vaccine against COVID-19 disease confirmed by PCR test and symptoms
    • Time Frame: Measured through Month 4 study visit
    • Evaluated by SARS-CoV-2 infection confirmed by PCR and diagnosed post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR after Month 1 visit; reporting at least 2 of the following systemic symptoms: Fever (≥ 38ºC), chills, myalgia, headache, sore throat; or reporting at least one of the following signs/symptoms: cough, shortness of breath or difficulty breathing, new olfactory or taste disorder, clinical or radiographical evidence of pneumonia, thromboembolic event, myocardial infarction, myocarditis, chilblains, or multi-inflammatory syndrome
  • Effect of Moderna COVID-19 Vaccine on magnitude of viral load over time
    • Time Frame: Measured through Month 4 study visit
    • Summary measures of the viral load curve, all evaluated among participants diagnosed with SARS-CoV-2 infection post Month 1 visit who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR through Month 1 visit
  • Efficacy of Moderna vaccine regardless of baseline serostatus (SARS-CoV-2 infection by PCR)
    • Time Frame: Measured through Month 4 study visit
    • Evaluated by SARS-CoV-2 infection diagnosed by PCR
  • Effect of Moderna vaccine on viral load regardless of baseline serostatus (Viral load)
    • Time Frame: Measured through Month 4 study visit
    • Evaluated by peak viral load in nasal samples from diagnosed participants
  • Effect of Moderna vaccine on secondary status regardless of baseline serostatus (Secondary transmission events)
    • Time Frame: Measured through Month 4 study visit
    • Evaluated by number of secondary transmission events in close-contact cohorts
  • Immunogenicity of Moderna COVID-19 vaccine
    • Time Frame: Measured through Month 2
    • Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
  • Immune responses as correlates of risk of SARS-CoV-2 acquisition, viral load, secondary infection, and COVID-19 disease
    • Time Frame: Measured through Month 2
    • Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
  • Efficacy of Moderna COVID-19 vaccine against asymptomatic SARS-CoV-2 infection
    • Time Frame: Measured through Month 4 study visit
    • SARS-CoV-2 infection by PCR or periodic serology after Month 1 visit
  • Efficacy of Moderna COVID-19 Vaccine against SARS-CoV-2 infection and COVID-19 disease
    • Time Frame: Measured through Month 4 study visit
    • SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR through Month 1 visit and who received all planned immunizations at designated immunization visits
  • Effect of Moderna COVID-19 Vaccine on viral load
    • Time Frame: Measured through Month 4 study visit
    • Measure of peak viral load among participants who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR through Month 1 visit and who received all planned immunizations at designated immunization visits
  • Effect of Moderna COVID-19 Vaccine on secondary transmission
    • Time Frame: Measured through Month 4 study visit
    • Measure of secondary transmission events among participants who were SARS-CoV-2 seronegative at enrollment and SARS-CoV-2 negative by PCR after Month 1 visit and who received all planned immunizations at designated immunization visits

Participating in This Clinical Trial

Inclusion Criteria

  • Enrollment in a post-secondary educational institution and 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. – Ability and willingness to provide informed consent. – Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. – Willing to be randomized to either immediate or delayed vaccination 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 Telehealth visits. Exclusion Criteria:

  • 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. – 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 26 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Institute of Allergy and Infectious Diseases (NIAID)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kathryn Stephenson, Study Chair, Harvard University School of Medicine
    • Audrey Pettifor, Study Chair, Gillings School of Global Public Health, University of North Carolina
    • Jasmine Marcelin, Study Chair, University of Nebraska

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