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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

NCT ID: NCT05279365

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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SARS CoV 2 Infection COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pfizer/BioNTech (BNT162b2)

Intervention Type BIOLOGICAL

participants will receive a booster dose (1st booster or 2nd booster) of vaccine

Moderna

Intervention Type BIOLOGICAL

participants will receive a booster dose (1st booster or 2nd booster) of vaccine

Interventions

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Pfizer/BioNTech (BNT162b2)

participants will receive a booster dose (1st booster or 2nd booster) of vaccine

Intervention Type BIOLOGICAL

Moderna

participants will receive a booster dose (1st booster or 2nd booster) of vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DHR Health Institute for Research and Development

OTHER

Sponsor Role lead

Responsible Party

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Sohail Rao

President & Chief Executive Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sohail Rao, MD,MA,DPhil

Role: PRINCIPAL_INVESTIGATOR

DHR Health Institute for Research and Development

Locations

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Brownsville Independent School District

Brownsville, Texas, United States

Site Status RECRUITING

DHR Health Institute for Research and Development

Edinburg, Texas, United States

Site Status RECRUITING

Edinburg CISD School Based Health Center

Edinburg, Texas, United States

Site Status RECRUITING

Starr County Memorial Hospital

Rio Grande City, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sohail Rao, MD,MA,DPhil

Role: CONTACT

[email protected]
956-362-2387

Monica Betancourt-Garcia, MD

Role: CONTACT

[email protected]
956-362-3223

Facility Contacts

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Sohail Rao, MD, MA, DPhil

Role: primary

[email protected]
956-362-2387

Monica Betancourt-Garcia, MD

Role: backup

[email protected]
956-362-3223

Sohail Rao, MD,MA,DPhil

Role: primary

[email protected]
956-362-2387

Monica Betancourt-Garcia, MD

Role: backup

[email protected]
956-362-3223

Sohail Rao, MD,MA, DPhil

Role: primary

[email protected]
956-362-2387

Monica Betancourt-Garcia, MD

Role: backup

[email protected]
956-362-3223

Sohail Rao, MD, MA, DPhil

Role: primary

[email protected]
956-362-2387

Monica Betancourt-Garcia, MD

Role: backup

[email protected]
956-362-3223

Other Identifiers

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1789039

Identifier Type: -

Identifier Source: org_study_id

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