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

Phase 2

• Conditions: SARS CoV 2 Infection; COVID-19
• Interventions: Biological: Pfizer/BioNTech (BNT162b2); Biological: Moderna

• Registration Number: NCT05279365
• Lead Sponsor: DHR Health Institute for Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Status Verified: 2022-03
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of Booster Dose	Pfizer/BioNTech (BNT162b2)	study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly.
Administration of Booster Dose	Moderna	study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly.

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Brownsville Independent School District; 🇺🇸 Brownsville, Texas, United States

DHR Health Institute for Research and Development; 🇺🇸 Edinburg, Texas, United States

Edinburg CISD School Based Health Center; 🇺🇸 Edinburg, Texas, United States

Starr County Memorial Hospital; 🇺🇸 Rio Grande City, Texas, United States