Systemic and Mucosal IgA Responses Are Variably Induced in Response to SARS-CoV-2 mRNA Vaccination and Are Associated With Protection Against Subsequent Infection
Networks
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Datasets
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Variables
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The overall aim of the study is to explore whether intra-muscular mRNA vaccination regimes confer a local IgA response in the oral cavity and whether the IgA response is associated with protection against breakthrough infection.
The objectives of the study are to:
* Measure SARS-CoV-2-specific Ab in saliva samples from participants who had received either BNT162b2 or mRNA-1273 vaccinations.
* Determine whether levels of vaccine-induced anti-Spike/RBD IgG or IgA differed in people who subsequently experienced a SARS-CoV-2 infection.
- Start Year
- 2021
| Investigators | Contacts |
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Design
- Study design
- Cohort
- Supplementary Information
- The study includes two observational cohorts (LTCH staff, MSB), a prospective cohort (LTCH Residents), and and a case-control cohort (Sheba HCW). Supplimentary information is available on the [Supplemental Figures and Tables](https://www.medrxiv.org/content/medrxiv/early/2022/01/02/2021.08.01.21261297/DC1/embed/media-1.pdf?download=true) document.
Marker Paper
Sheikh-Mohamed S, Isho B, Chao, et al. Systemic and mucosal IgA responses are variably induced in response to SARS-CoV-2 mRNA vaccination and are associated with protection against subsequent infection. MedRxiv, 2021.2021-08.
Recruitment
- Recruitment Target
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- Individuals
Number of Participants
- Number of Participants
- 2,090
- Number of Participants with Biological Samples
- 479
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Populations
The population is composed of individuals over the age of 18 who are working in long-term care homes (LTCH) and are receiving the mRNA1273 or BNT162b2 COVID-19 vaccine.
Selection Criteria
- Minimum age
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18
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Ethnic Origin
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- Health Status
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- Participants are excluded if they have a PCR confirmed COVID-19 infection.
- Other Criteria
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Participants are the working staff of long-term care homes.
Individuals are excluded if they received their second COVID-19 vaccine dose over six weeks before enrollment or if they are not interested in receiving a COVID-19 vaccine.
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Members of an association
- Supplementary Information
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Staff are recruited from one of twelve participating long-term care homes. The staff are invited by phone to participate if they did not opt-out of further communication about the study.
Number of Participants
- Number of Participants
- 125
- Number of Participants with Biological Samples
- 125
- Supplementary Information about selection criteria
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
MIReCoV - LTCH staff - 2 to 4 weeks post-dose 2
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Saliva samples were collected. | 2021 | 2021 |
| 1 |
MIReCoV - LTCH staff - 6 months post-dose 2
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Saliva samples are collected. | 2021 |
The population is composed of unexposed, asymptomatic individuals who live in an area of very low COVID-19 case numbers in Ontario (Grey County or the Greater Toronto Area) in April of 2020 or are individuals recruited from the University of Saskatchewan from the pre-COVID era.
Selection Criteria
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Greater Toronto Area, Grey County, Saskatchewan
- Ethnic Origin
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- Health Status
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- Participants are unexposed asymptomatic individuals.
Recruitment
- Sources of recruitment
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- General population
- General Population
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- Selected sample
- Supplementary Information
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Pre-COVID era samples were collected at the University of Saskatchewan.
Number of Participants
- Number of Participants
- 129
- Number of Participants with Biological Samples
- 129
- Supplementary Information about selection criteria
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COVID-19 era: 51 participants
Pre-COVID era: 78 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
MIReCoV - Negative control group - pre-COVID-19 era
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Blood and saliva samples were collected. | 2020 | 2020 |
| 1 |
MIReCoV - Negative control group - COVID-19 era
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Blood and saliva samples were collected. | 2020 | 2020 |
The population is composed of acute and convalescent COVID-19 patients from one of four Toronto Invasive Bacterial Diseases Network hospitals.
Selection Criteria
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Toronto
- Ethnic Origin
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- Health Status
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- Participants have acute or convalescent COVID-19 (confirmed by PCR test).
- Other Criteria
- Participants are in- and out-patients admitted to one of four Toronto Invasive Bacterial Diseases Network hospitals.
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Clinic patients
- Supplementary Information
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Participants are recruited from one of four participating Toronto Invasive Bacterial Diseases Network hospitals.
Number of Participants
- Number of Participants
- 78
- Number of Participants with Biological Samples
- 78
- Supplementary Information about selection criteria
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Convalescent pattients: 52 participants
Acute patients: 26 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
MIReCoV - COVID-19 patients - Hospital admission
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Blood and saliva samples were collected. Information was collected about age, sex, symptom onset date, and disease severity (mild, moderate, and severe) from patient medical records. | 2021 | 2021 |
| 1 |
MIReCoV - COVID-19 patients - 4 to 12 weeks post-symptom onset
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Blood and saliva samples were collected. | 2021 | 2021 |
The population is composed of individuals recruited independently by the Medical Sciences Building (MSB) at the University of Toronto in Toronto, Ontario. Participants receive two doses of the BNT1162b2 COVID-19 vaccine three months apart.
Selection Criteria
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Toronto
- Ethnic Origin
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- Health Status
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Participants are healthy adults who were not exposed to COVID-19 prior to enrollment.
- Other Criteria
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Participants must receive two doses of the BNT1162b2 COVID-19 vaccine three months apart.
Recruitment
- Sources of recruitment
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- General population
- General Population
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- Selected sample
- Supplementary Information
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Participants were independently recruited at the University of Toronto.
Number of Participants
- Number of Participants
- 63
- Number of Participants with Biological Samples
- 63
- Supplementary Information about selection criteria
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MSB-1 cohort: 27 participants
MSB-2 cohort: 36 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
MIReCoV - MSB - Pre-vaccination
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Blood and saliva samples were collected. | 2021 | 2021 |
| 1 |
MIReCoV - MSB - 2 to 4 weeks post-dose 1
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Blood and saliva samples were collected. | 2021 | 2021 |
| 2 |
MIReCoV - MSB - 3 months post-dose 1
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Blood and saliva samples were collected. | 2021 | 2021 |
| 3 |
MIReCoV - MSB - 2 to 4 weeks post-dose 2
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Blood and saliva samples were collected. | 2021 | 2021 |
The population is composed of Long Term Care (LTC) residents who were offered the mRNA-1273 COVID-19 vaccine on 4 January and 2 February 2021. Participants were selected if their COVID-19 status was confirmed by a polymerase chain reaction (PCR) test at the time of a COVID-19 outbreak.
Selection Criteria
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Ethnic Origin
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- Health Status
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- Other Criteria
- Participants are long-term care residents.
- Supplementary Information about selection criteria
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By 28 March 2021, 81% of residents had received 2 vaccine doses and 6% of residents had received vaccine 1 dose.
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Members of an association
- Supplementary Information
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Residents are recruited from their long-term care homes.
Number of Participants
- Number of Participants
- 198
- Number of Participants with Biological Samples
- 17
- Supplementary Information about selection criteria
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Biological samples were taken from PCR confirmed cases.
Uninfected during outbreak: 12 participants
Infected during outbreak: 5 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
MIReCoV - LTC residents - 2 to 4 weeks post-dose 2
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Blood samples were collected. | 2021 | 2021 |
| 1 |
MIReCoV - LTC residents - COVID-19 outbreak
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Blood samples were collected. | 2021 | 2021 |
The population is composed of healthcare workers (HCW) at the Sheba Medical Center in Isreal who received two doses of the BNT162b2 vaccine and who either experience a breakthrough infection (including asymptomatic infections) or are uninfected by COVID-19. Participants are screened by a reverse-transcriptase polymerase chain reaction (RT-PCR) test. Uninfected individuals are chosen as the control group if they are age- and sex-matched to the participants experiencing breakthrough infections.
Selection Criteria
- Newborns
- Twins
- Countries
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- Israel
- Territory
- Ramat Gan
- Ethnic Origin
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- Health Status
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- Other Criteria
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Participants are vaccinated healthcare workers who received two doses of the BNT162b2 COVID-19 vaccine.
Uninfected participants must match the sex, age, the interval between the second vaccination and the serologic (peri-infection), and immunosuppression status of the infected participants.
Participants must have their infection or uninfected status confirmed by RT-PCR test.
- Supplementary Information about selection criteria
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Members of an association
- Supplementary Information
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Participants are recruited from the Sheba Medical Center in Isreal.
Number of Participants
- Number of Participants
- 1,497
- Number of Participants with Biological Samples
- 67
- Supplementary Information about selection criteria
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Breakthrough infection cases: 11 participants
Age- and sex- matched uninfected controls: 56 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
MIReCoV - Sheba HCW - 2 to 4 weeks post-dose 2
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Blood samples were collected. | 2021 | 2021 |
| 1 |
MIReCoV - Sheba HCW - COVID-19 outbreak
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Blood samples were collected. | 2021 | 2021 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
Socio-demographic and economic characteristics
Age/birthdate
Sex/gender
Residence
Diseases
Certain infectious and parasitic diseases (A00-B99)
Neoplasms (C00-D48)
Endocrine, nutritional and metabolic diseases (E00-E90)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
Diseases of the genitourinary system (N00-N99)
Diseases without precise specification or falling into multiple categories
Medication and supplements
Medication and supplement intake
Non-pharmacological interventions
Laboratory diagnosis interventions
Physical measures and assessments
Anthropometry
Laboratory measures
Virology
Administrative information
Date and time-related information