Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 29 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Immediate Vaccination
Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29.
  • 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.
    Other names:
    • mRNA-1273
Experimental
Standard of care
Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141.
  • 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.
    Other names:
    • mRNA-1273
No Intervention
Vaccine Declined
Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study

Recruiting Locations

More Details

NCT ID
NCT04811664
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.