PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS

Last updated: March 14, 2022
Sponsor: DHR Health Institute for Research and Development
Overall Status: Active - Recruiting

Phase

2/3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05279365
1789039
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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-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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18 years and over that have been fully vaccinated (2 doses) with thePfizer/BioNTech COVID-19 vaccine (BNT162b2) and with the 1st booster at least 90 daysprior to the 2nd booster
  • Healthcare workers employed by and/or affiliated with DHR Health, Renaissance MedicalFoundation, DHR Partners, Starr County Memorial Hospital
  • Any adult with any of the following risk factors for severe COVID-19 diseaseprogression (as outlined by the CDC)

Exclusion

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 orModerna
  • Healthcare workers not employed by and/or affiliated with DHR Health, RenaissanceMedical Foundation, Star County Memorial Hospital or non DHR Partners

Study Design

Total Participants: 1000
Study Start date:
July 30, 2021
Estimated Completion Date:
August 31, 2023

Connect with a study center

  • Brownsville Independent School District

    Brownsville, Texas 78521
    United States

    Active - Recruiting

  • DHR Health Institute for Research and Development

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Edinburg CISD School Based Health Center

    Edinburg, Texas 78542
    United States

    Active - Recruiting

  • Starr County Memorial Hospital

    Rio Grande City, Texas 78582
    United States

    Active - Recruiting

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