PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 1,000
- Locations
- 8
- Primary Endpoint
- Levels of anti-SARS-CoV-2 IgG antibody titers after booster
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Levels of anti-SARS-CoV-2 IgG antibody titers after booster
Time Frame: 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
Number of participants infected with SARS-CoV-2 after booster Dose
Time Frame: 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.
Secondary Outcomes
- Measure rate of decline of immune responses(24 months)
- Identify differences in immune responses based on comorbidity status(24 months)
Investigators
Sohail Rao
President & Chief Executive Officer
DHR Health Institute for Research and Development