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CoVPN 3006: A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT04811664
Collaborator
(none)
1,958
Enrollment
51
Locations
3
Arms
9.2
Actual Duration (Months)
38.4
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Moderna COVID-19 Vaccine
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1958 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Mar 24, 2021
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate Vaccination

Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml IM 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: Delayed Vaccination

    Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml IM 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

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of Moderna COVID-19 Vaccine against SARS-CoV-2 infection [Measured through Month 4 study visit]

      SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment

    2. Effect of Moderna COVID-19 Vaccine on peak nasal viral load [Measured through Month 4 study visit]

      As a measure of infection and a proxy of infectiousness, peak viral load in nasal samples from participants diagnosed with SARS-CoV-2 infection among participants who were SARS-CoV-2 seronegative at enrollment

    Secondary Outcome Measures

    1. Impact of Moderna COVID-19 Vaccine on secondary transmission of SARS-CoV-2 infection [Measured through Month 4 study visit]

      Evaluated by the number of secondary transmission events in close-contact cohorts from main study participants who were SARS-CoV-2 seronegative at enrollment

    2. Efficacy of Moderna COVID-19 Vaccine to prevent serologically confirmed SARS-CoV-2 infection [Measured through Month 4 study visit]

      Evaluated by SARS-CoV-2 antibodies to the nucleocapsid protein post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment

    3. Efficacy of Moderna COVID-19 Vaccine against COVID-19 disease confirmed by PCR test and symptoms [Measured through Month 4 study visit]

      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

    4. Effect of Moderna COVID-19 Vaccine on magnitude of viral load over time [Measured through Month 4 study visit]

      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

    5. Efficacy of Moderna vaccine regardless of baseline serostatus (SARS-CoV-2 infection by PCR) [Measured through Month 4 study visit]

      Evaluated by SARS-CoV-2 infection diagnosed by PCR

    6. Effect of Moderna vaccine on viral load regardless of baseline serostatus (Viral load) [Measured through Month 4 study visit]

      Evaluated by peak viral load in nasal samples from diagnosed participants

    7. Effect of Moderna vaccine on secondary status regardless of baseline serostatus (Secondary transmission events) [Measured through Month 4 study visit]

      Evaluated by number of secondary transmission events in close-contact cohorts

    8. Immunogenicity of Moderna COVID-19 vaccine [Measured through Month 2]

      Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays

    9. Immune responses as correlates of risk of SARS-CoV-2 acquisition, viral load, secondary infection, and COVID-19 disease [Measured through Month 2]

      Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays

    10. Efficacy of Moderna COVID-19 vaccine against asymptomatic SARS-CoV-2 infection [Measured through Month 4 study visit]

      SARS-CoV-2 infection by PCR or periodic serology

    11. Efficacy of Moderna COVID-19 Vaccine against SARS-CoV-2 infection and COVID-19 disease [Measured through Month 4 study visit]

      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

    12. Effect of Moderna COVID-19 Vaccine on viral load [Measured through Month 4 study visit]

      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

    13. Effect of Moderna COVID-19 Vaccine on secondary transmission [Measured through Month 4 study visit]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria 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.

    Exclusion Criteria 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama CRS Birmingham Alabama United States 35222
    2 Headlands Research Scottsdale Scottsdale Arizona United States 85260
    3 AMR Phoenix Tempe Arizona United States 85281
    4 University of Arizona Tucson Arizona United States 85724
    5 Charles Drew University Los Angeles California United States 90059
    6 UC Davis Sacramento California United States 95817
    7 University of California, San Diego San Diego California United States 92103
    8 University of Colorado- Boulder Boulder Colorado United States 80301
    9 JEM Headlands LLC Atlantis Florida United States 33462
    10 University of Florida Gainesville Florida United States 32610
    11 UF CARES Jacksonville Florida United States 32209
    12 Orlando Immunology Center CRS Orlando Florida United States 32803
    13 Headlands Research Sarasota Sarasota Florida United States 34243
    14 University of South Florida Tampa Florida United States 33612
    15 Morehouse University Atlanta Georgia United States 30310
    16 The Hope Clinic of the Emory Vaccine Center CRS Decatur Georgia United States 30030
    17 Champaign-Urbana Public Health District Champaign Illinois United States 61820
    18 Rush University CRS Chicago Illinois United States 60612
    19 Northwestern University Evanston Illinois United States 60208
    20 Indiana University Bloomington Indiana United States 47405-7000
    21 Univ, of Kansas School of Medicine CRS Wichita Kansas United States 67214
    22 University of Kentucky Lexington Kentucky United States 40536
    23 Centex Studies, Inc. - Lake Charles Lake Charles Louisiana United States 70601
    24 University of Maryland College Park College Park Maryland United States 20742-2611
    25 Fenway Health (FH) CRS Boston Massachusetts United States 02215-4302
    26 Wayne State - Harper Hospital Detroit Michigan United States 48201
    27 University of Minnesota Minneapolis Minnesota United States 55455
    28 Columbia - Missouri VTEU Columbia Missouri United States 65201
    29 Washington University Therapeutics CRS Saint Louis Missouri United States 63110
    30 University of Nebraska Omaha Nebraska United States 68105
    31 AMR Las Vegas Las Vegas Nevada United States 89119
    32 University of New Mexico Albuquerque New Mexico United States 87131
    33 Bronx Prevention Research Center CRS Bronx New York United States 10451
    34 NYU Long Island Vaccine Center Mineola New York United States 11501
    35 NYU Bellevue Vaccine Center New York New York United States 10016
    36 Harlem Prevention Center CRS New York New York United States 10027
    37 New York Blood Center CRS New York New York United States 10065
    38 Stony Brook University Stony Brook New York United States 11794
    39 University of North Carolina Chapel Hill North Carolina United States 27599
    40 Wake Forest University Winston-Salem North Carolina United States 27157
    41 The Miriam Hopsital CRS Providence Rhode Island United States 02904
    42 Clemson University Clemson South Carolina United States 29634
    43 Vanderbilt Vaccine CRS Nashville Tennessee United States 37232
    44 Texas Tech Amarillo Texas United States 79106
    45 Centex Studies, Inc. - Brownsville Brownsville Texas United States 78526
    46 Texas A&M University College Station Texas United States 77843
    47 Centex Studies, Inc. - Houston Houston Texas United States 77058
    48 Centex Studies, Inc. - Westfield Houston Texas United States 77090
    49 Texas A&M - Kingsville Kingsville Texas United States 77843
    50 University of Virginia Charlottesville Virginia United States 22908
    51 University of Washington Seattle Washington United States 98109

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: Kathryn Stephenson, Harvard University School of Medicine
    • Study Chair: Audrey Pettifor, Gillings School of Global Public Health, University of North Carolina
    • Study Chair: Jasmine Marcelin, University of Nebraska

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT04811664
    Other Study ID Numbers:
    • CoVPN 3006
    First Posted:
    Mar 23, 2021
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    SARS-CoV-2
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    COVID-19

    Study Results

    No Results Posted as of Jun 14, 2022