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

Primary Purpose

SARS CoV 2 Infection, COVID-19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pfizer/BioNTech (BNT162b2)
Moderna
Sponsored by
DHR Health Institute for Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS CoV 2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brownsville Independent School DistrictRecruiting
  • DHR Health Institute for Research and DevelopmentRecruiting
  • Edinburg CISD School Based Health CenterRecruiting
  • Starr County Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of Booster Dose

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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
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

Full Information

First Posted
March 14, 2022
Last Updated
March 14, 2022
Sponsor
DHR Health Institute for Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05279365
Brief Title
PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
Official Title
PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DHR Health Institute for Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV 2 Infection, COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of Booster Dose
Arm Type
Experimental
Arm Description
study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
Pfizer/BioNTech (BNT162b2)
Intervention Description
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
Intervention Type
Biological
Intervention Name(s)
Moderna
Intervention Description
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
Primary Outcome Measure Information:
Title
Number of participants infected with SARS-CoV-2 after booster Dose
Description
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
Title
Levels of anti-SARS-CoV-2 IgG antibody titers after booster
Description
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
Secondary Outcome Measure Information:
Title
Measure rate of decline of immune responses
Description
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
Title
Identify differences in immune responses based on comorbidity status
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohail Rao, MD,MA,DPhil
Phone
956-362-2387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Betancourt-Garcia, MD
Phone
956-362-3223
Email
m.betancourt@dhr-rgv.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD,MA,DPhil
Organizational Affiliation
DHR Health Institute for Research and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brownsville Independent School District
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD, MA, DPhil
Phone
956-362-2387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Monica Betancourt-Garcia, MD
Phone
956-362-3223
Email
m.betancourt@dhr-rgv.com
Facility Name
DHR Health Institute for Research and Development
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD,MA,DPhil
Phone
956-362-2387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Monica Betancourt-Garcia, MD
Phone
956-362-3223
Email
m.betancourt@dhr-rgv.com
Facility Name
Edinburg CISD School Based Health Center
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78542
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD,MA, DPhil
Phone
956-362-2387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Monica Betancourt-Garcia, MD
Phone
956-362-3223
Email
m.betancourt@dhr-rgv.com
Facility Name
Starr County Memorial Hospital
City
Rio Grande City
State/Province
Texas
ZIP/Postal Code
78582
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Rao, MD, MA, DPhil
Phone
956-362-2387
Email
s.rao@dhr-rgv.com
First Name & Middle Initial & Last Name & Degree
Monica Betancourt-Garcia, MD
Phone
956-362-3223
Email
m.betancourt@dhr-rgv.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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