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

March 14, 2022 updated by: Sohail Rao, DHR Health Institute for Research and Development
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Brownsville, Texas, United States, 78521
        • Recruiting
        • Brownsville Independent School District
        • Contact:
        • Contact:
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • DHR Health Institute for Research and Development
        • Contact:
        • Contact:
      • Edinburg, Texas, United States, 78542
        • Recruiting
        • Edinburg CISD School Based Health Center
        • Contact:
        • Contact:
      • Rio Grande City, Texas, United States, 78582
        • Recruiting
        • Starr County Memorial Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Administration of Booster Dose
study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly.
Biological: Pfizer/BioNTech (BNT162b2)
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
Biological: Moderna
participants will receive a booster dose (1st booster or 2nd booster) of vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure rate of decline of immune responses
Time Frame: 24 months
Determine the rate of decline of immune responses in various cohort of recipients with similar co-morbidities by conducting cohort analysis
24 months
Identify differences in immune responses based on comorbidity status
Time Frame: 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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DHR Health Institute for Research and Development

Investigators

  • Principal Investigator: Sohail Rao, MD,MA,DPhil, DHR Health Institute for Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 30, 2021

Primary Completion (ANTICIPATED)

August 31, 2022

Study Completion (ANTICIPATED)

August 31, 2023

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (ACTUAL)

March 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1789039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Pfizer/BioNTech (BNT162b2)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe