Clinical trial NCT04811664: A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection
Keywords: SARS-CoV-2
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2021-03-23
Enrollment: 1923
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection
timeFrame: Measured through Month 4 study visit
measure: Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load
timeFrame: Measured through Month 4 study visit
measure: Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load
timeFrame: Measured through Month 4 study visit
Secondary outcomes:
measure: Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms
timeFrame: Measured through Month 4 study visit
measure: Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity
timeFrame: Measured through Month 4 study visit
measure: Impact of Moderna COVID-19 Vaccine on Secondary Transmission of SARS-CoV-2 Infection
timeFrame: Measured through Month 4 study visit
measure: Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 Infection
timeFrame: Measured through Month 4 study visit
measure: Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms
timeFrame: Measured through Month 4 study visit
measure: Effect of Moderna COVID-19 Vaccine on Magnitude of Viral Load Over Time
timeFrame: Measured through Month 4 study visit
measure: Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR)
timeFrame: Measured through Month 4 study visit
measure: Effect of Moderna Vaccine on Viral Load Regardless of Baseline Serostatus (Viral Load)
timeFrame: Measured through Month 4 study visit
measure: Effect of Moderna Vaccine on Secondary Status Regardless of Baseline Serostatus (Secondary Transmission Events)
timeFrame: Measured through Month 4 study visit
measure: Immunogenicity of Moderna COVID-19 Vaccine
timeFrame: Measured through Month 2
measure: Immune Responses as Correlates of Risk of SARS-CoV-2 Acquisition, Viral Load, Secondary Infection, and COVID-19 Disease
timeFrame: Measured through Month 2
measure: Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection
timeFrame: Measured through Month 4 study visit
measure: Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection and COVID-19 Disease
timeFrame: Measured through Month 4 study visit
measure: Effect of Moderna COVID-19 Vaccine on Viral Load
timeFrame: Measured through Month 4 study visit
measure: Effect of Moderna COVID-19 Vaccine on Secondary Transmission
timeFrame: Measured through Month 4 study visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama CRS
state: Alabama
city: Scottsdale
country: United States
facility: Headlands Research Scottsdale
state: Arizona
city: Tempe
country: United States
facility: AMR Phoenix
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Charles Drew University
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Boulder
country: United States
facility: University of Colorado- Boulder
state: Colorado
city: Atlantis
country: United States
facility: JEM Headlands LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: UF CARES
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center CRS
state: Florida
city: Sarasota
country: United States
facility: Headlands Research Sarasota
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Morehouse University
state: Georgia
city: Decatur
country: United States
facility: The Hope Clinic of the Emory Vaccine Center CRS
state: Georgia
city: Champaign
country: United States
facility: Champaign-Urbana Public Health District
state: Illinois
city: Chicago
country: United States
facility: Rush University CRS
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Wichita
country: United States
facility: Univ, of Kansas School of Medicine CRS
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Lake Charles
country: United States
facility: Centex Studies, Inc. - Lake Charles
state: Louisiana
city: College Park
country: United States
facility: University of Maryland College Park
state: Maryland
city: Boston
country: United States
facility: Fenway Health (FH) CRS
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State - Harper Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbia
country: United States
facility: Columbia - Missouri VTEU
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Therapeutics CRS
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Las Vegas
country: United States
facility: AMR Las Vegas
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Bronx Prevention Research Center CRS
state: New York
city: Mineola
country: United States
facility: NYU Long Island Vaccine Center
state: New York
city: New York
country: United States
facility: NYU Bellevue Vaccine Center
state: New York
city: New York
country: United States
facility: Harlem Prevention Center CRS
state: New York
city: New York
country: United States
facility: New York Blood Center CRS
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Providence
country: United States
facility: The Miriam Hopsital CRS
state: Rhode Island
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Vaccine CRS
state: Tennessee
city: Amarillo
country: United States
facility: Texas Tech
state: Texas
city: Brownsville
country: United States
facility: Centex Studies, Inc. - Brownsville
state: Texas
city: College Station
country: United States
facility: Texas A&M University
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc. - Houston
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc. - Westfield
state: Texas
city: Kingsville
country: United States
facility: Texas A&M - Kingsville
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Harvard University School of Medicine
name: Kathryn Stephenson
role: STUDY_CHAIR
affiliation: Gillings School of Global Public Health, University of North Carolina
name: Audrey Pettifor
role: STUDY_CHAIR
affiliation: University of Nebraska
name: Jasmine Marcelin
role: STUDY_CHAIR
References: