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

NCT05279365 | Unknown Phase 2 FDA Drug

• 1 other identifier: 1789039
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 4

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.

Conditions

SARS CoV 2 Infection; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months

• 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

  24 months

Secondary Outcomes (2)

• Measure rate of decline of immune responses

  24 months

• Identify differences in immune responses based on comorbidity status

  24 months

Study Arms (1)

Administration of Booster Dose

EXPERIMENTAL

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); Biological: Moderna

Interventions

Pfizer/BioNTech (BNT162b2) BIOLOGICAL

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

Administration of Booster Dose

Moderna BIOLOGICAL

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

Administration of Booster Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• DHR Health Institute for Research and Development: lead

Study Sites (4)

Brownsville Independent School District

Brownsville, Texas, 78521, United States

RECRUITING

DHR Health Institute for Research and Development

Edinburg, Texas, 78539, United States

RECRUITING

Edinburg CISD School Based Health Center

Edinburg, Texas, 78542, United States

RECRUITING

Starr County Memorial Hospital

Rio Grande City, Texas, 78582, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Sohail Rao, MD,MA,DPhil

  DHR Health Institute for Research and Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohail Rao, MD,MA,DPhil

CONTACT

956-362-2387; s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

CONTACT

956-362-3223; m.betancourt@dhr-rgv.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President & Chief Executive Officer

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 15, 2022
• Study Start: July 30, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)