Status:
UNKNOWN
PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
Lead Sponsor:
DHR Health Institute for Research and Development
Conditions:
SARS CoV 2 Infection
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The recent rise in infections with the Omicron variant of the SARS-CoV-2 is alarming. Equally disconcerting is the fact that individuals who were previously vaccinated (\< 6 months) and have co-morbid...
Eligibility Criteria
Inclusion
- Adults 18 years and over that have been fully vaccinated (2 doses) with the Pfizer/BioNTech COVID-19 vaccine (BNT162b2) and with the 1st booster at least 90 days prior to the 2nd booster
- Healthcare workers employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, DHR Partners, Starr County Memorial Hospital
- Any adult with any of the following risk factors for severe COVID-19 disease progression (as outlined by the CDC)
Exclusion
- Previous history of allergic reaction to vaccination
- less than or equal to 3 months from last booster dose of vaccine
- active SARS-COV-2 infection
- less than or equal to 21 days of full recovery from SARS-CoV-2 infection
- less than or equal to 14 days of any vaccination
- vaccinated with any other available COVID-19 vaccine other than Pfizer/BioNTech or Moderna
- Healthcare workers not employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, Star County Memorial Hospital or non DHR Partners
Key Trial Info
Start Date :
July 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05279365
Start Date
July 30 2021
End Date
August 31 2023
Last Update
March 29 2022
Active Locations (4)
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1
Brownsville Independent School District
Brownsville, Texas, United States, 78521
2
DHR Health Institute for Research and Development
Edinburg, Texas, United States, 78539
3
Edinburg CISD School Based Health Center
Edinburg, Texas, United States, 78542
4
Starr County Memorial Hospital
Rio Grande City, Texas, United States, 78582