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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT04811664
Phase
PHASE3
Status
Completed

Conditions

  • SARS-CoV-2 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 29 Years
Healthy Volunteers
Accepted

Interventions

  • Moderna COVID-19 Vaccine — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
Mar 23, 2021
Start date
Mar 24, 2021
Status verified
Jul 2023
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021

Study Design

Enrollment
1,923 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.
  • 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

Primary Outcome Measure

Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection [ Time Frame: Measured through Month 4 study visit ]

Locations (51)

FacilityCityStateZIPSite coordinators
Alabama CRSBirminghamAlabama35222-
Headlands Research ScottsdaleScottsdaleArizona85260-
AMR PhoenixTempeArizona85281-
University of ArizonaTucsonArizona85724-
Charles Drew UniversityLos AngelesCalifornia90059-
UC DavisSacramentoCalifornia95817-
University of California, San DiegoSan DiegoCalifornia92103-
University of Colorado- BoulderBoulderColorado80301-
JEM Headlands LLCAtlantisFlorida33462-
University of FloridaGainesvilleFlorida32610-
UF CARESJacksonvilleFlorida32209-
Orlando Immunology Center CRSOrlandoFlorida32803-
Headlands Research SarasotaSarasotaFlorida34243-
University of South FloridaTampaFlorida33612-
Morehouse UniversityAtlantaGeorgia30310-
The Hope Clinic of the Emory Vaccine Center CRSDecaturGeorgia30030-
Champaign-Urbana Public Health DistrictChampaignIllinois61820-
Rush University CRSChicagoIllinois60612-
Northwestern UniversityEvanstonIllinois60208-
Indiana UniversityBloomingtonIndiana47405-7000-
Univ, of Kansas School of Medicine CRSWichitaKansas67214-
University of KentuckyLexingtonKentucky40536-
Centex Studies, Inc. - Lake CharlesLake CharlesLouisiana70601-
University of Maryland College ParkCollege ParkMaryland20742-2611-
Fenway Health (FH) CRSBostonMassachusetts02215-4302-
Wayne State - Harper HospitalDetroitMichigan48201-
University of MinnesotaMinneapolisMinnesota55455-
Columbia - Missouri VTEUColumbiaMissouri65201-
Washington University Therapeutics CRSSt LouisMissouri63110-
University of NebraskaOmahaNebraska68105-
AMR Las VegasLas VegasNevada89119-
University of New MexicoAlbuquerqueNew Mexico87131-
NYU Long Island Vaccine CenterMineolaNew York11501-
Harlem Prevention Center CRSNew YorkNew York10027-
New York Blood Center CRSNew YorkNew York10065-
NYU Bellevue Vaccine CenterNew YorkNew York10016-
Stony Brook UniversityStony BrookNew York11794-
Bronx Prevention Research Center CRSThe BronxNew York10451-
University of North CarolinaChapel HillNorth Carolina27599-
Wake Forest UniversityWinston-SalemNorth Carolina27157-
The Miriam Hopsital CRSProvidenceRhode Island02904-
Clemson UniversityClemsonSouth Carolina29634-
Vanderbilt Vaccine CRSNashvilleTennessee37232-
Texas TechAmarilloTexas79106-
Centex Studies, Inc. - BrownsvilleBrownsvilleTexas78526-
Texas A&M UniversityCollege StationTexas77843-
Centex Studies, Inc. - HoustonHoustonTexas77058-
Centex Studies, Inc. - WestfieldHoustonTexas77090-
Texas A&M - KingsvilleKingsvilleTexas77843-
University of VirginiaCharlottesvilleVirginia22908-
University of WashingtonSeattleWashington98109-

Find similar trials in Birmingham, AL

By research site
Alabama CRS· Birmingham, ALHeadlands Research Scottsdale· Scottsdale, AZAMR Phoenix· Tempe, AZUniversity of Arizona· Tucson, AZCharles Drew University· Los Angeles, CAUC Davis· Sacramento, CA

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