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SARS-CoV-2 InfectionPhase 3CoVPN 3006NCT04811664

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

A Phase 3 study testing Moderna COVID-19 Vaccine in people with SARS-CoV-2 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Infection
What is being tested?
Moderna COVID-19 Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,923 participants
Where
51 sitesUnited States
Study dates
24 Mar 2021to 30 Dec 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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).

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Texas Tech

    Amarillo, Texas, 79106

  • Morehouse University

    Atlanta, Georgia, 30310

  • JEM Headlands LLC

    Atlantis, Florida, 33462

  • Alabama CRS

    Birmingham, Alabama, 35222

  • Indiana University

    Bloomington, Indiana, 47405-7000

  • Fenway Health (FH) CRS

    Boston, Massachusetts, 02215-4302

  • University of Colorado- Boulder

    Boulder, Colorado, 80301

  • Centex Studies, Inc. - Brownsville

    Brownsville, Texas, 78526

  • Champaign-Urbana Public Health District

    Champaign, Illinois, 61820

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Rush University CRS

    Chicago, Illinois, 60612

  • Clemson University

    Clemson, South Carolina, 29634

  • University of Maryland College Park

    College Park, Maryland, 20742-2611

  • Texas A&M University

    College Station, Texas, 77843

  • Columbia - Missouri VTEU

    Columbia, Missouri, 65201

  • The Hope Clinic of the Emory Vaccine Center CRS

    Decatur, Georgia, 30030

  • Wayne State - Harper Hospital

    Detroit, Michigan, 48201

  • Northwestern University

    Evanston, Illinois, 60208

  • University of Florida

    Gainesville, Florida, 32610

  • Centex Studies, Inc. - Houston

    Houston, Texas, 77058

  • Centex Studies, Inc. - Westfield

    Houston, Texas, 77090

  • UF CARES

    Jacksonville, Florida, 32209

  • Texas A&M - Kingsville

    Kingsville, Texas, 77843

  • Centex Studies, Inc. - Lake Charles

    Lake Charles, Louisiana, 70601

  • AMR Las Vegas

    Las Vegas, Nevada, 89119

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Charles Drew University

    Los Angeles, California, 90059

  • NYU Long Island Vaccine Center

    Mineola, New York, 11501

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt Vaccine CRS

    Nashville, Tennessee, 37232

  • NYU Bellevue Vaccine Center

    New York, New York, 10016

  • Harlem Prevention Center CRS

    New York, New York, 10027

  • New York Blood Center CRS

    New York, New York, 10065

  • University of Nebraska

    Omaha, Nebraska, 68105

  • Orlando Immunology Center CRS

    Orlando, Florida, 32803

  • The Miriam Hopsital CRS

    Providence, Rhode Island, 02904

  • UC Davis

    Sacramento, California, 95817

  • University of California, San Diego

    San Diego, California, 92103

  • Headlands Research Sarasota

    Sarasota, Florida, 34243

  • Headlands Research Scottsdale

    Scottsdale, Arizona, 85260

  • University of Washington

    Seattle, Washington, 98109

  • Washington University Therapeutics CRS

    St Louis, Missouri, 63110

  • Stony Brook University

    Stony Brook, New York, 11794

  • University of South Florida

    Tampa, Florida, 33612

  • AMR Phoenix

    Tempe, Arizona, 85281

  • Bronx Prevention Research Center CRS

    The Bronx, New York, 10451

  • University of Arizona

    Tucson, Arizona, 85724

  • Univ, of Kansas School of Medicine CRS

    Wichita, Kansas, 67214

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Moderna COVID-19 Vaccine
Keywords
SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moderna COVID-19 VaccineBiological

    Also called mRNA-1273

    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.

Study groups in NCT04811664
Study groupRoleWhat they receive
Immediate VaccinationExperimentalParticipants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29.
Receives: Biological: Moderna COVID-19 Vaccine
Standard of careExperimentalParticipants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141.
Receives: Biological: Moderna COVID-19 Vaccine
Vaccine DeclinedNo interventionParticipants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured through Month 4 study visit

  2. 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: Measured through Month 4 study visit

  3. 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: Measured through Month 4 study visit

Secondary outcomes (15)

  1. 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: Measured through Month 4 study visit

  2. 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: Measured through Month 4 study visit

  3. 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: Measured through Month 4 study visit

  4. 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: Measured through Month 4 study visit

  5. 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: Measured through Month 4 study visit

  6. 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: Measured through Month 4 study visit

  7. Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR)

    Evaluated by SARS-CoV-2 infection diagnosed by PCR

    Measured: Measured through Month 4 study visit

  8. 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: Measured through Month 4 study visit

  9. 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: Measured through Month 4 study visit

  10. Immunogenicity of Moderna COVID-19 Vaccine

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

    Measured: Measured through Month 2

  11. 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: Measured through Month 2

  12. Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection

    SARS-CoV-2 infection by PCR or periodic serology

    Measured: Measured through Month 4 study visit

  13. 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: Measured through Month 4 study visit

  14. 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: Measured through Month 4 study visit

  15. 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: Measured through Month 4 study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start24 Mar 2021
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
1,923 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811664
Sponsor's protocol ID
CoVPN 3006
Acronym
CoVPN 3006
Status last verified
Jul 2023
First submitted
19 Mar 2021
Last updated
2 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Vielot NA, Kelly NK, Ludema C, Rosenberg M, Brown ER, Janes HE, Kublin JG, Stephenson KE, Marcelin JR, Pettifor A. Patterns and predictors of COVID-19 vaccination among young adults at 44 US sites: Secondary analysis of a randomized, controlled, open-label trial, March - December 2021. Vaccine. 2024 Oct 3;42(23):126237. doi: 10.1016/j.vaccine.2024.126237. Epub 2024 Aug 24.

    PubMed 39182315

  • Stephenson KE, Marcelin JR, Pettifor AE, Janes H, Brown E, Neradilek M, Yen C, Andriesen J, Grunenberg N, Espy N, Trahey M, Fischer RSB, DeSouza CA, Shisler JL, Connick E, Houpt ER, Chu HY, McCulloh RJ, Becker-Dreps S, Vielot NA, Kalbaugh CA, Cherabuddi K, Krueger KM, Rosenberg M, Greenberg RN, Joaquin A, Immergluck LC, Corey L, Kublin JG. Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021. Open Forum Infect Dis. 2023 Nov 2;10(11):ofad511. doi: 10.1093/ofid/ofad511. eCollection 2023 Nov.

    PubMed 38023544

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Moderna COVID-19 Vaccine in people with SARS-CoV-2 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection (time frame: Measured through Month 4 study visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04811664, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.

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