A Randomized Controlled Study to Assess SARS CoV-2 Infection, Viral Shedding, and Subsequent Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,923
- 试验地点
- 51
- 主要终点
- Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Immediate Vaccination
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.
干预措施: Moderna COVID-19 Vaccine (Biological)
Standard of care
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.
干预措施: Moderna COVID-19 Vaccine (Biological)
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
结局指标
主要结局
Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load
时间窗: 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.
Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection
时间窗: 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 Median Peak Nasal Viral Load
时间窗: 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.
次要结局
- Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms(Measured through Month 4 study visit)
- Immunogenicity of Moderna COVID-19 Vaccine(Measured through Month 2)
- Immune Responses as Correlates of Risk of SARS-CoV-2 Acquisition, Viral Load, Secondary Infection, and COVID-19 Disease(Measured through Month 2)
- Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection(Measured through Month 4 study visit)
- Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection and COVID-19 Disease(Measured through Month 4 study visit)
- Effect of Moderna COVID-19 Vaccine on Secondary Transmission(Measured through Month 4 study visit)
- Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR)(Measured through Month 4 study visit)
- Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity(Measured through Month 4 study visit)
- Effect of Moderna Vaccine on Viral Load Regardless of Baseline Serostatus (Viral Load)(Measured through Month 4 study visit)
- Effect of Moderna COVID-19 Vaccine on Magnitude of Viral Load Over Time(Measured through Month 4 study visit)
- Impact of Moderna COVID-19 Vaccine on Secondary Transmission of SARS-CoV-2 Infection(Measured through Month 4 study visit)
- Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 Infection(Measured through Month 4 study visit)
- Effect of Moderna Vaccine on Secondary Status Regardless of Baseline Serostatus (Secondary Transmission Events)(Measured through Month 4 study visit)
- Effect of Moderna COVID-19 Vaccine on Viral Load(Measured through Month 4 study visit)