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

SARS-CoV-2 Infection Clinical Trial

— CoVPN 3006  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811664
• Other study ID #: CoVPN 3006
• Status: Completed
• Phase: Phase 3
• Start date: March 24, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2023
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1923
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Texas Tech	Amarillo	Texas
United States	Morehouse University	Atlanta	Georgia
United States	JEM Headlands LLC	Atlantis	Florida
United States	Alabama CRS	Birmingham	Alabama
United States	Indiana University	Bloomington	Indiana
United States	Fenway Health (FH) CRS	Boston	Massachusetts
United States	University of Colorado- Boulder	Boulder	Colorado
United States	Bronx Prevention Research Center CRS	Bronx	New York
United States	Centex Studies, Inc. - Brownsville	Brownsville	Texas
United States	Champaign-Urbana Public Health District	Champaign	Illinois
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University CRS	Chicago	Illinois
United States	Clemson University	Clemson	South Carolina
United States	University of Maryland College Park	College Park	Maryland
United States	Texas A&M University	College Station	Texas
United States	Columbia - Missouri VTEU	Columbia	Missouri
United States	The Hope Clinic of the Emory Vaccine Center CRS	Decatur	Georgia
United States	Wayne State - Harper Hospital	Detroit	Michigan
United States	Northwestern University	Evanston	Illinois
United States	University of Florida	Gainesville	Florida
United States	Centex Studies, Inc. - Houston	Houston	Texas
United States	Centex Studies, Inc. - Westfield	Houston	Texas
United States	UF CARES	Jacksonville	Florida
United States	Texas A&M - Kingsville	Kingsville	Texas
United States	Centex Studies, Inc. - Lake Charles	Lake Charles	Louisiana
United States	AMR Las Vegas	Las Vegas	Nevada
United States	University of Kentucky	Lexington	Kentucky
United States	Charles Drew University	Los Angeles	California
United States	NYU Long Island Vaccine Center	Mineola	New York
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt Vaccine CRS	Nashville	Tennessee
United States	Harlem Prevention Center CRS	New York	New York
United States	New York Blood Center CRS	New York	New York
United States	NYU Bellevue Vaccine Center	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Orlando Immunology Center CRS	Orlando	Florida
United States	The Miriam Hopsital CRS	Providence	Rhode Island
United States	UC Davis	Sacramento	California
United States	Washington University Therapeutics CRS	Saint Louis	Missouri
United States	University of California, San Diego	San Diego	California
United States	Headlands Research Sarasota	Sarasota	Florida
United States	Headlands Research Scottsdale	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington
United States	Stony Brook University	Stony Brook	New York
United States	University of South Florida	Tampa	Florida
United States	AMR Phoenix	Tempe	Arizona
United States	University of Arizona	Tucson	Arizona
United States	Univ, of Kansas School of Medicine CRS	Wichita	Kansas
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection	Incidence of SARS-CoV-2 infection diagnosed by study PCR among baseline negative participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.	Measured through Month 4 study visit
Primary	Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load	As a measure of infection and a proxy of infectiousness, mean observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.	Measured through Month 4 study visit
Primary	Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load	As a measure of infection and a proxy of infectiousness, median observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.	Measured through Month 4 study visit
Secondary	Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms	Incidence of study PCR-confirmed SARS-CoV-2 infection and concurrent symptoms captured by daily or weekly symptom reporting (at least one of the following: hospitalization, fever, chills, cough, shortness of breath, difficulty breathing, tiredness/fatigue, muscle aches, joint aches, body aches, headache, change in sense of taste, change in sense of smell, sore throat, nasal congestion, runny nose, nausea, vomiting, diarrhea, oral ulcers and clinical or radiographical evidence of pneumonia) among baseline negative participants. Exposure starting from first study PCR and censored at last PCR/outside vaccination. Participants without concurrent symptom data were assumed not symptomatic and were additionally censored at SARS-CoV-2 infection. Exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.	Measured through Month 4 study visit
Secondary	Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity	Incidence of SARS-CoV-2 infection diagnosed by study PCR among FAS-P participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.	Measured through Month 4 study visit
Secondary	Impact of Moderna COVID-19 Vaccine on Secondary Transmission of SARS-CoV-2 Infection	Evaluated by the number of secondary transmission events in close-contact cohorts from main study participants who were SARS-CoV-2 seronegative at enrollment	Measured through Month 4 study visit
Secondary	Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 Infection	Evaluated by SARS-CoV-2 antibodies to the nucleocapsid protein post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment	Measured through Month 4 study visit
Secondary	Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms	Evaluated by SARS-CoV-2 infection confirmed by PCR among participants who were SARS-CoV-2 seronegative at enrollment; reporting at least 2 of the following systemic symptoms: Fever (= 38ºC), chills, myalgia, headache, sore throat; or reporting at least one of the following signs/symptoms: cough, shortness of breath or difficulty breathing, new olfactory or taste disorder, clinical or radiographical evidence of pneumonia, thromboembolic event, myocardial infarction, myocarditis, chilblains, or multi-inflammatory syndrome	Measured through Month 4 study visit
Secondary	Effect of Moderna COVID-19 Vaccine on Magnitude of Viral Load Over Time	Summary measures of the viral load curve, all evaluated among participants diagnosed with SARS-CoV-2 infection who were SARS-CoV-2 seronegative at enrollment	Measured through Month 4 study visit
Secondary	Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR)	Evaluated by SARS-CoV-2 infection diagnosed by PCR	Measured through Month 4 study visit
Secondary	Effect of Moderna Vaccine on Viral Load Regardless of Baseline Serostatus (Viral Load)	Evaluated by peak viral load in nasal samples from diagnosed participants	Measured through Month 4 study visit
Secondary	Effect of Moderna Vaccine on Secondary Status Regardless of Baseline Serostatus (Secondary Transmission Events)	Evaluated by number of secondary transmission events in close-contact cohorts	Measured through Month 4 study visit
Secondary	Immunogenicity of Moderna COVID-19 Vaccine	Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays	Measured through Month 2
Secondary	Immune Responses as Correlates of Risk of SARS-CoV-2 Acquisition, Viral Load, Secondary Infection, and COVID-19 Disease	Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays	Measured through Month 2
Secondary	Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection	SARS-CoV-2 infection by PCR or periodic serology	Measured through Month 4 study visit
Secondary	Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection and COVID-19 Disease	SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits	Measured through Month 4 study visit
Secondary	Effect of Moderna COVID-19 Vaccine on Viral Load	Measure of peak viral load among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits	Measured through Month 4 study visit
Secondary	Effect of Moderna COVID-19 Vaccine on Secondary Transmission	Measure of secondary transmission events among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits	Measured through Month 4 study visit