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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279365
• Other study ID #: 1789039
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 30, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2022
• Source: DHR Health Institute for Research and Development
• Contact: Sohail Rao, MD,MA,DPhil
• Phone: 956-362-2387
• Email: s.rao[@]dhr-rgv.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Pfizer/BioNTech (BNT162b2)
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
• Moderna
participants will receive a booster dose (1st booster or 2nd booster) of vaccine

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
DHR Health Institute for Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	24 months
Secondary	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	24 months