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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 Criteria

  • 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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Administration of Booster Dose 		study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly.
  • Biological: Pfizer/BioNTech (BNT162b2)
    participants will receive a booster dose (1st booster or 2nd booster) of vaccine
  • Biological: Moderna
    participants will receive a booster dose (1st booster or 2nd booster) of vaccine

Recruiting Locations

Brownsville Independent School District
Brownsville, Texas 78521
Contact:
Sohail Rao, MD, MA, DPhil
956-362-2387
s.rao@dhr-rgv.com

DHR Health Institute for Research and Development
Edinburg, Texas 78539
Contact:
Sohail Rao, MD,MA,DPhil
956-362-2387
s.rao@dhr-rgv.com

Edinburg CISD School Based Health Center
Edinburg, Texas 78542
Contact:
Sohail Rao, MD,MA, DPhil
956-362-2387
s.rao@dhr-rgv.com

Starr County Memorial Hospital
Rio Grande City, Texas 78582
Contact:
Sohail Rao, MD, MA, DPhil
956-362-2387
s.rao@dhr-rgv.com

More Details

NCT ID
NCT05279365
Status
Unknown status
Sponsor
DHR Health Institute for Research and Development

Study Contact

Sohail Rao, MD,MA,DPhil
956-362-2387
s.rao@dhr-rgv.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.