NCT05279365

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: DHR Health Institute for Research and Development · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-30
• Primary completion: 2022-08-31
• Completion: 2023-08-31
• First posted: 2022-03-15
• Last updated: 2022-03-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study