SARS-CoV-2 Infection
Conditions
Keywords
SARS-CoV-2
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.
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.
Interventions
BIOLOGICALModerna 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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection | Measured through Month 4 study visit | 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. |
| Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Measured through Month 4 study visit | 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. |
| Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Measured through Month 4 study visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms | Measured through Month 4 study visit | 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity | Measured through Month 4 study visit | 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Vaccination Immediate Vaccination Group: Participants 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. | 600 |
| Standard of Care Standard of Care Group: Participants 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. | 549 |
| Vaccine Declined 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 | 311 |
| Total | 1,460 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Early Study Closure | 3 | 7 | 79 |
| Overall Study | Lost to Follow-up | 78 | 125 | 46 |
| Overall Study | Other (Unable to receive payment visa status) | 0 | 2 | 0 |
| Overall Study | Participant is unwilling or unable to comply with required study | 24 | 47 | 16 |
| Overall Study | Participant Unable to Adhere to Visit Schedule | 6 | 13 | 17 |
| Overall Study | Protocol Violation | 0 | 5 | 11 |
| Overall Study | Study Terminated by Sponsor | 4 | 3 | 34 |
| Overall Study | Withdrawal by Subject | 39 | 76 | 12 |
Baseline characteristics
| Characteristic | Total | Vaccine Declined | Standard of Care | Immediate Vaccination |
|---|---|---|---|---|
| Age, Continuous | 21 years | 22 years | 21 years | 21 years |
| Age, Customized 18 - 22 years | 1008 Participants | 157 Participants | 402 Participants | 449 Participants |
| Age, Customized 23 - 26 years | 334 Participants | 84 Participants | 128 Participants | 122 Participants |
| Age, Customized 27 - 29 years | 118 Participants | 70 Participants | 19 Participants | 29 Participants |
| Current participation in any in-person team sport No | 1351 Participants | 288 Participants | 504 Participants | 559 Participants |
| Current participation in any in-person team sport Yes | 104 Participants | 20 Participants | 44 Participants | 40 Participants |
| In last 2 weeks, potential exposure to SARS-CoV-2 No, not to my knowledge | 1421 Participants | 291 Participants | 534 Participants | 596 Participants |
| In last 2 weeks, potential exposure to SARS-CoV-2 Yes, someone with a recent positive test | 23 Participants | 10 Participants | 9 Participants | 4 Participants |
| In last 2 weeks, potential exposure to SARS-CoV-2 Yes, someone with possible symptoms, but no diagnosis or test | 7 Participants | 3 Participants | 4 Participants | 0 Participants |
| In last 2 weeks, potential exposure to SARS-CoV-2 Yes, third party notification system | 5 Participants | 4 Participants | 1 Participants | 0 Participants |
| In last 2 weeks, sat inside a bar, restaurant, cafe, cafeteria No | 443 Participants | 63 Participants | 181 Participants | 199 Participants |
| In last 2 weeks, sat inside a bar, restaurant, cafe, cafeteria Yes | 1012 Participants | 245 Participants | 367 Participants | 400 Participants |
| In last 2 weeks, usual alcohol consumption 3-4 times per week | 82 Participants | 19 Participants | 29 Participants | 34 Participants |
| In last 2 weeks, usual alcohol consumption 5-6 times per week | 14 Participants | 5 Participants | 4 Participants | 5 Participants |
| In last 2 weeks, usual alcohol consumption Everyday | 8 Participants | 5 Participants | 2 Participants | 1 Participants |
| In last 2 weeks, usual alcohol consumption None | 707 Participants | 145 Participants | 272 Participants | 290 Participants |
| In last 2 weeks, usual alcohol consumption Once every other week | 258 Participants | 67 Participants | 97 Participants | 94 Participants |
| In last 2 weeks, usual alcohol consumption Once per week | 196 Participants | 36 Participants | 69 Participants | 91 Participants |
| In last 2 weeks, usual alcohol consumption Twice per week | 190 Participants | 31 Participants | 75 Participants | 84 Participants |
| In last 2 weeks, usual number of drinks when consuming alcohol 1-3 drinks | 589 Participants | 125 Participants | 214 Participants | 250 Participants |
| In last 2 weeks, usual number of drinks when consuming alcohol 4-6 drinks | 136 Participants | 31 Participants | 51 Participants | 54 Participants |
| In last 2 weeks, usual number of drinks when consuming alcohol 7 drinks or more | 15 Participants | 3 Participants | 9 Participants | 3 Participants |
| In last 2 weeks, usual number of drinks when consuming alcohol Did not drink alcohol | 715 Participants | 149 Participants | 274 Participants | 292 Participants |
| In last 2 weeks when leaving home, encountered people not wearing masks All of the time | 149 Participants | 75 Participants | 36 Participants | 38 Participants |
| In last 2 weeks when leaving home, encountered people not wearing masks Most of the time | 166 Participants | 74 Participants | 41 Participants | 51 Participants |
| In last 2 weeks when leaving home, encountered people not wearing masks Never | 83 Participants | 7 Participants | 32 Participants | 44 Participants |
| In last 2 weeks when leaving home, encountered people not wearing masks Occasionally | 470 Participants | 58 Participants | 205 Participants | 207 Participants |
| In last 2 weeks when leaving home, encountered people not wearing masks Often | 297 Participants | 76 Participants | 111 Participants | 110 Participants |
| In last 2 weeks when leaving home, encountered people not wearing masks Rarely | 290 Participants | 18 Participants | 123 Participants | 149 Participants |
| In last 2 weeks when leaving home, maintained physical distancing from others All of the time | 329 Participants | 40 Participants | 129 Participants | 160 Participants |
| In last 2 weeks when leaving home, maintained physical distancing from others Most of the time | 555 Participants | 73 Participants | 239 Participants | 243 Participants |
| In last 2 weeks when leaving home, maintained physical distancing from others Never | 46 Participants | 28 Participants | 9 Participants | 9 Participants |
| In last 2 weeks when leaving home, maintained physical distancing from others Occasionally | 185 Participants | 77 Participants | 55 Participants | 53 Participants |
| In last 2 weeks when leaving home, maintained physical distancing from others Often | 254 Participants | 48 Participants | 96 Participants | 110 Participants |
| In last 2 weeks when leaving home, maintained physical distancing from others Rarely | 86 Participants | 42 Participants | 20 Participants | 24 Participants |
| In last 2 weeks when leaving home, met with others in a group of 10 or more All of the time | 23 Participants | 13 Participants | 1 Participants | 9 Participants |
| In last 2 weeks when leaving home, met with others in a group of 10 or more Most of the time | 17 Participants | 9 Participants | 5 Participants | 3 Participants |
| In last 2 weeks when leaving home, met with others in a group of 10 or more Never | 584 Participants | 71 Participants | 240 Participants | 273 Participants |
| In last 2 weeks when leaving home, met with others in a group of 10 or more Occasionally | 246 Participants | 69 Participants | 74 Participants | 103 Participants |
| In last 2 weeks when leaving home, met with others in a group of 10 or more Often | 84 Participants | 38 Participants | 23 Participants | 23 Participants |
| In last 2 weeks when leaving home, met with others in a group of 10 or more Rarely | 501 Participants | 108 Participants | 205 Participants | 188 Participants |
| In last 2 weeks when leaving home, worn a mask inside when around other people All of the time | 570 Participants | 48 Participants | 236 Participants | 286 Participants |
| In last 2 weeks when leaving home, worn a mask inside when around other people Most of the time | 364 Participants | 49 Participants | 153 Participants | 162 Participants |
| In last 2 weeks when leaving home, worn a mask inside when around other people Never | 100 Participants | 57 Participants | 23 Participants | 20 Participants |
| In last 2 weeks when leaving home, worn a mask inside when around other people Occasionally | 161 Participants | 59 Participants | 54 Participants | 48 Participants |
| In last 2 weeks when leaving home, worn a mask inside when around other people Often | 149 Participants | 38 Participants | 53 Participants | 58 Participants |
| In last 2 weeks when leaving home, worn a mask inside when around other people Rarely | 111 Participants | 57 Participants | 29 Participants | 25 Participants |
| In-person on-campus class attendance 0 days/week | 746 Participants | 67 Participants | 316 Participants | 363 Participants |
| In-person on-campus class attendance 1 day/week | 118 Participants | 5 Participants | 51 Participants | 62 Participants |
| In-person on-campus class attendance 2-4 days/week | 283 Participants | 70 Participants | 107 Participants | 106 Participants |
| In-person on-campus class attendance 5 or more days/week | 115 Participants | 56 Participants | 30 Participants | 29 Participants |
| In-person on-campus class attendance Not a student | 193 Participants | 110 Participants | 44 Participants | 39 Participants |
| In-person work, volunteer, or on-campus study time 0 days/week | 497 Participants | 88 Participants | 192 Participants | 217 Participants |
| In-person work, volunteer, or on-campus study time 1 day/week | 143 Participants | 12 Participants | 56 Participants | 75 Participants |
| In-person work, volunteer, or on-campus study time 2-4 days/week | 483 Participants | 89 Participants | 187 Participants | 207 Participants |
| In-person work, volunteer, or on-campus study time 5 or more days/week | 332 Participants | 119 Participants | 113 Participants | 100 Participants |
| Member of a fraternity or sorority No | 1319 Participants | 299 Participants | 480 Participants | 540 Participants |
| Member of a fraternity or sorority Yes | 136 Participants | 9 Participants | 68 Participants | 59 Participants |
| Number of people in shared communal space 0 | 166 Participants | 37 Participants | 63 Participants | 66 Participants |
| Number of people in shared communal space 1 | 412 Participants | 95 Participants | 145 Participants | 172 Participants |
| Number of people in shared communal space 2 | 304 Participants | 62 Participants | 124 Participants | 118 Participants |
| Number of people in shared communal space >2 | 573 Participants | 114 Participants | 216 Participants | 243 Participants |
| Number of roommates (sleep in same room) 0 | 904 Participants | 150 Participants | 362 Participants | 392 Participants |
| Number of roommates (sleep in same room) 1 | 451 Participants | 124 Participants | 157 Participants | 170 Participants |
| Number of roommates (sleep in same room) >1 | 100 Participants | 34 Participants | 29 Participants | 37 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 6 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 201 Participants | 11 Participants | 93 Participants | 97 Participants |
| Race/Ethnicity, Customized Black or African American | 143 Participants | 47 Participants | 49 Participants | 47 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 276 Participants | 71 Participants | 99 Participants | 106 Participants |
| Race/Ethnicity, Customized More than one race | 121 Participants | 26 Participants | 43 Participants | 52 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 1175 Participants | 237 Participants | 448 Participants | 490 Participants |
| Race/Ethnicity, Customized Other | 40 Participants | 8 Participants | 13 Participants | 19 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 50 Participants | 14 Participants | 13 Participants | 23 Participants |
| Race/Ethnicity, Customized White | 895 Participants | 203 Participants | 334 Participants | 358 Participants |
| Region of Enrollment USA | 1460 Participants | 311 Participants | 549 Participants | 600 Participants |
| Residence Apartment building or condo | 689 Participants | 146 Participants | 258 Participants | 285 Participants |
| Residence Dormitory or campus housing | 186 Participants | 21 Participants | 78 Participants | 87 Participants |
| Residence Fraternity or sorority house | 19 Participants | 0 Participants | 10 Participants | 9 Participants |
| Residence No residence | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Residence Other | 45 Participants | 6 Participants | 18 Participants | 21 Participants |
| Residence RV / Trailer | 10 Participants | 3 Participants | 3 Participants | 4 Participants |
| Residence Shelter | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Residence Stand-alone house (non-fraternity or sorority) | 496 Participants | 128 Participants | 178 Participants | 190 Participants |
| Residence Staying with friends / Couch surfing | 9 Participants | 2 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 819 Participants | 184 Participants | 294 Participants | 341 Participants |
| Sex: Female, Male Male | 641 Participants | 127 Participants | 255 Participants | 259 Participants |
| Sex/Gender, Customized Gender Nonconforming/Gender Variant | 13 Participants | 3 Participants | 7 Participants | 3 Participants |
| Sex/Gender, Customized Genderqueer | 4 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex/Gender, Customized Man | 628 Participants | 126 Participants | 248 Participants | 254 Participants |
| Sex/Gender, Customized Multiple | 18 Participants | 1 Participants | 7 Participants | 10 Participants |
| Sex/Gender, Customized Other | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Sex/Gender, Customized Transgender Man | 5 Participants | 1 Participants | 1 Participants | 3 Participants |
| Sex/Gender, Customized Transgender Woman | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Unknown | 9 Participants | 4 Participants | 0 Participants | 5 Participants |
| Sex/Gender, Customized Woman | 778 Participants | 175 Participants | 282 Participants | 321 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Measured through Month 4 study visit
Population: FAS-P viral load
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Vaccination | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:Corteva, Target:N1 | 25.8 Cycle Thresholds |
| Immediate Vaccination | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:Corteva, Target:N2 | 26.3 Cycle Thresholds |
| Immediate Vaccination | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:UW/Northwell, Target:N1 | 34.4 Cycle Thresholds |
| Immediate Vaccination | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:UW/Northwell, Target:N2 | 34.1 Cycle Thresholds |
| Standard of Care | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:UW/Northwell, Target:N2 | 30.5 Cycle Thresholds |
| Standard of Care | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:Corteva, Target:N1 | 20.2 Cycle Thresholds |
| Standard of Care | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:UW/Northwell, Target:N1 | 28.8 Cycle Thresholds |
| Standard of Care | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:Corteva, Target:N2 | 20.7 Cycle Thresholds |
| Vaccine Declined | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:UW/Northwell, Target:N2 | 26.2 Cycle Thresholds |
| Vaccine Declined | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:Corteva, Target:N2 | 22.8 Cycle Thresholds |
| Vaccine Declined | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:UW/Northwell, Target:N1 | 24.4 Cycle Thresholds |
| Vaccine Declined | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | Lab:Corteva, Target:N1 | 22.3 Cycle Thresholds |
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.
Time frame: Measured through Month 4 study visit
Population: FAS-P viral load
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immediate Vaccination | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:Corteva, Target:N1 | 23.9 Cycle Thresholds |
| Immediate Vaccination | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:Corteva, Target:N2 | 24.3 Cycle Thresholds |
| Immediate Vaccination | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:UW/Northwell, Target:N1 | 34.4 Cycle Thresholds |
| Immediate Vaccination | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:UW/Northwell, Target:N2 | 34.1 Cycle Thresholds |
| Standard of Care | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:UW/Northwell, Target:N2 | 31.2 Cycle Thresholds |
| Standard of Care | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:Corteva, Target:N1 | 19.6 Cycle Thresholds |
| Standard of Care | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:UW/Northwell, Target:N1 | 29.4 Cycle Thresholds |
| Standard of Care | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:Corteva, Target:N2 | 20.0 Cycle Thresholds |
| Vaccine Declined | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:UW/Northwell, Target:N2 | 25.7 Cycle Thresholds |
| Vaccine Declined | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:Corteva, Target:N2 | 21.3 Cycle Thresholds |
| Vaccine Declined | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:UW/Northwell, Target:N1 | 22.5 Cycle Thresholds |
| Vaccine Declined | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | Lab:Corteva, Target:N1 | 21.0 Cycle Thresholds |
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.
Time frame: Measured through Month 4 study visit
Population: Baseline negative with outside vaccination censored incidence rate follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Vaccination | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection | 12.2 events per 100 person years |
| Standard of Care | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection | 31.8 events per 100 person years |
| Vaccine Declined | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection | 89.6 events per 100 person years |
Comparison: Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.95% CI: [-14.1, 80.3]
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
Secondary
Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection
SARS-CoV-2 infection by PCR or periodic serology
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
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.
Time frame: Measured through Month 4 study visit
Population: Baseline negative with outside vaccination censored incidence rate follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Vaccination | Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms | 4.5 events per 100 person years |
| Standard of Care | Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms | 18.5 events per 100 person years |
| Vaccine Declined | Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms | 53.8 events per 100 person years |
Comparison: Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.95% CI: [-9.5, 92.3]
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
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.
Time frame: Measured through Month 4 study visit
Population: FAS-P with outside vaccination censored incidence rate follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Vaccination | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity | 11.7 events per 100 person years |
| Standard of Care | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity | 28.3 events per 100 person years |
| Vaccine Declined | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity | 76.0 events per 100 person years |
Comparison: Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.95% CI: [-37.7, 74.9]
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
Secondary
Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR)
Evaluated by SARS-CoV-2 infection diagnosed by PCR
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.
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
Time frame: Measured through Month 2
Population: Data have not been collected and outcome cannot be reported.
Secondary
Immunogenicity of Moderna COVID-19 Vaccine
Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
Time frame: Measured through Month 2
Population: Data have not been collected and outcome cannot be reported.
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
Time frame: Measured through Month 4 study visit
Population: Data have not been collected and outcome cannot be reported.