Summary

Eligibility
for people ages 18-26 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

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

Details

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.

Keywords

SARS-CoV-2 Infection SARS-CoV-2 Infection Communicable Diseases Moderna COVID-19 Vaccine Immediate Vaccination Delayed Vaccination

Eligibility

You can join if…

Open to people ages 18-26

  • Enrollment in a participating university and willingness to be followed for the planned duration of the study.
  • Agrees to allow study staff to access university 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 defer SARS-CoV-2 licensed or EUA vaccine until visit 6 (Month 4)
  • 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.

You CAN'T join if...

  • Acutely ill or febrile 72 hours prior to or at screening. Fever is defined as a body temperature ≥ 38.0°C/100.4°F. Volunteers meeting this criterion may be rescheduled within the relevant window periods. Afebrile 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.

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92103 United States
  • Charles Drew University accepting new patients
    Los Angeles California 90059 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT04811664
Phase
Phase 3
Study Type
Interventional
Last Updated