Official Title
PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
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 (< 6months) and have co-morbidities that are considered high risk, are gettingre-infected...a process referred to as "breakthrough". There is some evidence that inthese high risk individuals, the gradual decrease in immunity against the virus asdepicted 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/BioNTechand/or Moderna and ascertain the levels of antibodies at various times pre and postvaccination. The incidence of infection with SARS-CoV-2 after booster vaccination willalso be obtained.

Detailed Description

Not Provided

Unknown status
SARS CoV 2 Infection
COVID-19

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Brownsville Independent School District
Brownsville, Texas, United States

DHR Health Institute for Research and Development
Edinburg, Texas, United States

Edinburg CISD School Based Health Center
Edinburg, Texas, United States

Starr County Memorial Hospital
Rio Grande City, Texas, United States

Contacts

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

Monica Betancourt-Garcia, MD
956-362-3223
m.betancourt@dhr-rgv.com

Sohail Rao, MD,MA,DPhil, Principal Investigator
DHR Health Institute for Research and Development

DHR Health Institute for Research and Development
NCT Number
MeSH Terms
COVID-19