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

Study Overview
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Brief Summary
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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.

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

Conditions
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SARS CoV 2 Infection, COVID-19

Intervention / Treatment
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* Biological: Pfizer/BioNTech (BNT162b2)
* Biological: Moderna


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of Booster Dose<br>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)<br>* participants will receive a booster dose (1st booster or 2nd booster) of vaccine<br>Biological: Moderna<br>* participants will receive a booster dose (1st booster or 2nd booster) of vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants infected with SARS-CoV-2 after booster Dose | Determine effectiveness of booster dose in the prevention of SARS-CoV-2 Infection by assessing if subjects remain free from infections with SARS-CoV-2 after receiving booster dose. | 24 months | 
| Levels of anti-SARS-CoV-2 IgG antibody titers after booster | Determine the anti-SARS-CoV-2 IgG antibody titers using a semi quantitative method at various time points (Baseline/Day 0, Day 14, Week 12 and Week 24 after booster) to assess for sustained levels of relatively high titers of anti-SARS-CoV-2 IgG in the blood of the subjects | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure rate of decline of immune responses | Determine the rate of decline of immune responses in various cohort of recipients with similar co-morbidities by conducting cohort analysis | 24 months | 
| Identify differences in immune responses based on comorbidity status | Identify differences in immune responses based on comorbidity status (e.g., Immune response in recipients with metabolic diseases vs. patients with immunosuppression) by using questionnaires | 24 months |