Clinical trial NCT05279365: PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
Official title: PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: SARS CoV 2 Infection
COVID-19
Lead sponsor: DHR Health Institute for Research and Development
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants infected with SARS-CoV-2 after booster Dose
timeFrame: 24 months
measure: Levels of anti-SARS-CoV-2 IgG antibody titers after booster
timeFrame: 24 months
Secondary outcomes:
measure: Measure rate of decline of immune responses
timeFrame: 24 months
measure: Identify differences in immune responses based on comorbidity status
timeFrame: 24 months
Other outcomes:
Locations:
city: Brownsville
country: United States
facility: Brownsville Independent School District
state: Texas
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development
state: Texas
city: Edinburg
country: United States
facility: Edinburg CISD School Based Health Center
state: Texas
city: Rio Grande City
country: United States
facility: Starr County Memorial Hospital
state: Texas
Study officials:
affiliation: DHR Health Institute for Research and Development
name: Sohail Rao, MD,MA,DPhil
role: PRINCIPAL_INVESTIGATOR
References: