PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
Status unconfirmed · Phase 2/Phase 3
Conditions studied: SARS CoV 2 Infection, COVID-19
In brief
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-morbidities that are considered high risk, are getting re-infected...a process referred to as "breakthrough". There is some evidence that in these high risk individuals, the gradual decrease in immunity against the virus as depicted by a drop in anti-SARS-CoV-2 antibodies, is responsible (partially or wholly) for this reinfection. In this study, we intend to give a booster does Pfizer/BioNTech and/or Moderna and ascertain the levels of antibodies at various times pre and post vaccination. The incidence of infection with SARS-CoV-2 after booster vaccination will also be obtained.
Key facts
- Study ID
- NCT05279365
- Run by
- DHR Health Institute for Research and Development
- People needed
- 1000
- Starts
- 2021-07-30
- Expected to finish
- 2023-08-31
- Last updated by the study team
- 2022-03-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Brownsville Independent School District — Brownsville, Texas, United States (enrolling)
- DHR Health Institute for Research and Development — Edinburg, Texas, United States (enrolling)
- Edinburg CISD School Based Health Center — Edinburg, Texas, United States (enrolling)
- Starr County Memorial Hospital — Rio Grande City, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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