COVID-19, SARS CoV 2 Infection
Conditions
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 (\< 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.
Interventions
BIOLOGICALPfizer/BioNTech (BNT162b2)
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
BIOLOGICALModerna
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
Sponsors
DHR Health Institute for Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants infected with SARS-CoV-2 after booster Dose | 24 months | 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. |
| Levels of anti-SARS-CoV-2 IgG antibody titers after booster | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure rate of decline of immune responses | 24 months | Determine the rate of decline of immune responses in various cohort of recipients with similar co-morbidities by conducting cohort analysis |
| Identify differences in immune responses based on comorbidity status | 24 months | 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 |
Countries
United States
Contacts
Primary ContactSohail Rao, MD,MA,DPhil
Backup ContactMonica Betancourt-Garcia, MD
Outcome results
None listed