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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Booster Dose | Experimental | study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pfizer/BioNTech (BNT162b2) | Biological | participants will receive a booster dose (1st booster or 2nd booster) of vaccine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sohail Rao, MD,MA,DPhil | Contact | 956-362-2387 | s.rao@dhr-rgv.com | |
| Monica Betancourt-Garcia, MD | Contact | 956-362-3223 | m.betancourt@dhr-rgv.com |
| Name | Affiliation | Role |
|---|---|---|
| Sohail Rao, MD,MA,DPhil | DHR Health Institute for Research and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brownsville Independent School District | Recruiting | Brownsville | Texas | 78521 | United States |
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| Moderna | Biological | participants will receive a booster dose (1st booster or 2nd booster) of vaccine |
|
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 |
| DHR Health Institute for Research and Development | Recruiting | Edinburg | Texas | 78539 | United States |
|
| Edinburg CISD School Based Health Center | Recruiting | Edinburg | Texas | 78542 | United States |
|
| Starr County Memorial Hospital | Recruiting | Rio Grande City | Texas | 78582 | United States |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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