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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
Brownsville Independent School District
Brownsville, Texas, United States
RECRUITINGDHR Health Institute for Research and Development
Edinburg, Texas, United States
RECRUITINGEdinburg CISD School Based Health Center
Edinburg, Texas, United States
RECRUITINGStarr County Memorial Hospital
Rio Grande City, Texas, United States
RECRUITINGNumber 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.
Time frame: 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
Time frame: 24 months
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
Time frame: 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
Time frame: 24 months
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