Summary

Eligibility
for people ages 18-29 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Sacramento, 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 individuals 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 Individuals 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 adults aged 18-29. In the Main study, up to 12,000 participants will be randomized 1:1 to Immediate Vaccination Group 1 (at Months 0 and 1) or Standard of Care Group 2, with vaccination given at Months 4 and 5 if not received off-study previously. Up to an additional 6,000 participants will be enrolled into the Vaccine Declined Group 3 and will also be offered vaccine at Months 4 and 5. Additional study visits for Group 1 will occur at Months 2 and 4; for Groups 2 and 3, 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 Infections Communicable Diseases COVID-19 Moderna COVID-19 Vaccine Immediate Vaccination Delayed Vaccination Vaccine Declined

Eligibility

You can join if…

Open to people ages 18-29

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.

You CAN'T join if...

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.

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 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)
Links
Sign up for this study
ID
NCT04811664
Phase
Phase 3
Study Type
Interventional
Last Updated