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

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ClinicalTrials.gov Identifier: NCT04811664
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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
SARS-CoV-2 Infection 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 24, 2021
Estimated Primary Completion Date : December 22, 2021
Estimated Study Completion Date : December 22, 2021

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 Name: 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 Name: 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



Primary Outcome Measures :
  1. Efficacy of Moderna COVID-19 Vaccine against SARS-CoV-2 infection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Measured through Month 4 study visit ]
    Evaluated by number of secondary transmission events in close-contact cohorts

  8. Immunogenicity of Moderna COVID-19 vaccine [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811664


Locations
Show Show 54 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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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
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04811664    
Other Study ID Numbers: CoVPN 3006
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021

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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:
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Infection
Communicable Diseases