Status:
UNKNOWN
Fourth COVID-19 Vaccine Dose- mRNA1273
Lead Sponsor:
Sheba Medical Center
Conditions:
COVID-19 Pandemic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The Omicron variant of concern (VOC) is currently rapidly spreading worldwide, with extremely high transmission rates, with an estimated R of \>3. The investigators now have preliminary, yet unpublis...
Detailed Description
The aim of the study is to assess the immunogenicity of a 4th dose, and its durability. This will be measured by following IgG, IgA, Pseudoneutralization assays, microneutralization, avidity, T-cell a...
Eligibility Criteria
Inclusion
- Age: Volunteer must be at least 18 years of age, at the time of signing the informed conset.
- Sex: Male or Female. All female volunteers of reproductive age will be requested to use contraceptive measures for the two months following enrolment.
- Received 3 doses of BNT162b2 with the 3rd dose at least 4 months previously.
- Have a serology test within the previous 3 months of 700 BAU or less.
- Responded to the previous vaccine doses, i.e. at least one IgG\>100.
- Medical Conditions: Volunteers with any medical condition are allowed, as long as they adhere to the criteria above.
- Agreed to attend all visits and signed the informed consent - -
Exclusion
- Had previous SARS-CoV-2 infection (detected by either PCR, anti-S IgG before the 1st vaccine dose, anti-N IgG at any stage).
- Had an allergic response to any of the previous BNT162b2 doses.
- Has history of myopericarditis.
- Report that they do not feel well or have a fever on the day of vaccination.
- Pregnant on day of recruitment -
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 4 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05230953
Start Date
January 5 2022
End Date
July 4 2024
Last Update
December 27 2023
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel, 5265601