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

• Sponsor: DHR Health Institute for Research and Development (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05279365
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 25
• Patients Per Site: 250
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SARS CoV 2 Infection; COVID-19	Biological: Pfizer/BioNTech (BNT162b2); Biological: Moderna	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
• Actual Study Start Date: Jul 30, 2021
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of participants infected with SARS-CoV-2 after booster Dose [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.

2. Levels of anti-SARS-CoV-2 IgG antibody titers after booster [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

Secondary Outcome Measures

1. Measure rate of decline of immune responses [24 months]

   Determine the rate of decline of immune responses in various cohort of recipients with similar co-morbidities by conducting cohort analysis

2. Identify differences in immune responses based on comorbidity status [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brownsville Independent School District	Brownsville	Texas	United States	78521
2	DHR Health Institute for Research and Development	Edinburg	Texas	United States	78539
3	Edinburg CISD School Based Health Center	Edinburg	Texas	United States	78542
4	Starr County Memorial Hospital	Rio Grande City	Texas	United States	78582

Sponsors and Collaborators

• DHR Health Institute for Research and Development

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sohail Rao, President & Chief Executive Officer, DHR Health Institute for Research and Development
• ClinicalTrials.gov Identifier: NCT05279365
• Other Study ID Numbers: 1789039
• First Posted: Mar 15, 2022
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Mar 29, 2022