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
Recruiting
CT.gov ID
NCT04811664
Collaborator
(none)
37,500
Enrollment
55
Locations
3
Arms
9
Anticipated Duration (Months)
681.8
Patients Per Site
76
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 DiseaseIntervention/TreatmentPhase
  • 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
Anticipated Enrollment :
37500 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
Anticipated Primary Completion Date :
Dec 22, 2021
Anticipated Study Completion Date :
Dec 22, 2021

Arms and Interventions

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Alabama CRSBirminghamAlabamaUnited States35222
    2Headlands Research ScottsdaleScottsdaleArizonaUnited States85260
    3AMR PhoenixTempeArizonaUnited States85281
    4University of ArizonaTucsonArizonaUnited States85724
    5Charles Drew UniversityLos AngelesCaliforniaUnited States90059
    6UC DavisSacramentoCaliforniaUnited States95817
    7University of California, San DiegoSan DiegoCaliforniaUnited States92103
    8University of Colorado- BoulderBoulderColoradoUnited States80301
    9JEM Headlands LLCAtlantisFloridaUnited States33462
    10University of FloridaGainesvilleFloridaUnited States32610
    11UF CARESJacksonvilleFloridaUnited States32209
    12Orlando Immunology Center CRSOrlandoFloridaUnited States32803
    13Headlands Research SarasotaSarasotaFloridaUnited States34243
    14University of South FloridaTampaFloridaUnited States33612
    15Morehouse UniversityAtlantaGeorgiaUnited States30310
    16The Hope Clinic of the Emory Vaccine Center CRSDecaturGeorgiaUnited States30030
    17Champaign-Urbana Public Health DistrictChampaignIllinoisUnited States61820
    18Rush University CRSChicagoIllinoisUnited States60612
    19Northwestern UniversityEvanstonIllinoisUnited States60208
    20Indiana UniversityBloomingtonIndianaUnited States47405-7000
    21Univ, of Kansas School of Medicine CRSWichitaKansasUnited States67214
    22University of KentuckyLexingtonKentuckyUnited States40536
    23Centex Studies, Inc. - Lake CharlesLake CharlesLouisianaUnited States70601
    24University of Maryland College ParkCollege ParkMarylandUnited States20742-2611
    25Fenway Health (FH) CRSBostonMassachusettsUnited States02215-4302
    26Wayne State - Harper HospitalDetroitMichiganUnited States48201
    27University of MinnesotaMinneapolisMinnesotaUnited States55455
    28Columbia - Missouri VTEUColumbiaMissouriUnited States65201
    29The Children's Mercy HospitalKansas CityMissouriUnited States64108
    30Washington University Therapeutics CRSSaint LouisMissouriUnited States63110
    31University of NebraskaOmahaNebraskaUnited States68105
    32AMR Las VegasLas VegasNevadaUnited States89119
    33University of New MexicoAlbuquerqueNew MexicoUnited States87131
    34Bronx Prevention Research Center CRSBronxNew YorkUnited States10451
    35NYU Long Island Vaccine CenterMineolaNew YorkUnited States11501
    36NYU Bellevue Vaccine CenterNew YorkNew YorkUnited States10016
    37Harlem Prevention Center CRSNew YorkNew YorkUnited States10027
    38New York Blood Center CRSNew YorkNew YorkUnited States10065
    39Stony Brook UniversityStony BrookNew YorkUnited States11794
    40University of North CarolinaChapel HillNorth CarolinaUnited States27599
    41Wake Forest UniversityWinston-SalemNorth CarolinaUnited States27157
    42Penn Prevention CRSPhiladelphiaPennsylvaniaUnited States19104
    43The Miriam Hopsital CRSProvidenceRhode IslandUnited States02904
    44Clemson UniversityClemsonSouth CarolinaUnited States29634
    45Vanderbilt Vaccine CRSNashvilleTennesseeUnited States37232
    46Texas TechAmarilloTexasUnited States79106
    47Centex Studies, Inc. - BrownsvilleBrownsvilleTexasUnited States78526
    48Texas A&M UniversityCollege StationTexasUnited States77843
    49Centex Studies, Inc. - HoustonHoustonTexasUnited States77058
    50Centex Studies, Inc. - WestfieldHoustonTexasUnited States77090
    51Texas A&M - KingsvilleKingsvilleTexasUnited States77843
    52Centex Studies, Inc. - McAllenMcAllenTexasUnited States78504
    53University of VirginiaCharlottesvilleVirginiaUnited States22908
    54University of WashingtonSeattleWashingtonUnited States98109
    55West Virginia UniversityMorgantownWest VirginiaUnited States26505

    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:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    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)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2021