Status:
COMPLETED
Immunogenicity and Safety of Fractional Booster Dose of COVID-19 Vaccines Available for Use in Pakistan/Brazil: A Phase 4 Dose-optimizing Trial
Lead Sponsor:
Albert B. Sabin Vaccine Institute
Collaborating Sponsors:
Aga Khan University
Oswaldo Cruz Foundation
Conditions:
COVID-19
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Since the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen in late 2019, millions of people around the world have fallen ill and died from coronavirus disea...
Eligibility Criteria
Inclusion
- Healthy male or female individuals aged 18 years to 60 years
- Participant is willing and able to give written informed consent for participation in the trial
- Individuals who can comply with trial procedures and are available for the duration of follow-up.
- Brazil:
- ● Previous vaccination with a complete primary series of Sinovac (Priming Group 1), AZD1222 (Priming Group 2), or BNT162b2 (Priming Group 3-B) at least 6 months prior to screening
- Pakistan:
- ● Previous vaccination with a complete primary series of Sinovac (Priming Group 1) or AZD1222 (Priming Group 2) at least 6 months prior to screening, or PCR-confirmed natural infection (Priming Group 3-P) between February 2021 - 6 months prior to screening
Exclusion
- Has a contraindication to BNT162b2, AZD1222 or Sinovac
- Has received an incomplete primary COVID-19 vaccination series
- Has received 3 doses of COVID-19 vaccine
- Has received heterologous primary COVID-19 vaccination series
- History of a solid organ or bone marrow transplant
- History of malignancy (other than non-melanoma skin cancer) within the past five years
- Currently on hemodialysis
- Any confirmed or suspected immunosuppressive or immunodeficiency condition or diagnosis
- On chronic (\>30 days) use of immunosuppressive medications at the time of enrollment (except topical steroids or short-term oral steroids, i.e., ≤14 days)
- Known diagnosis of HIV with CD4 count \<200 cells/mm3 (in the past 6 months)
- Active or history of previous auto-immune neurological disorders (e.g., multiple sclerosis, Guillain-Barre syndrome, transverse myelitis) (excluding Bell's palsy)
- Has received anti-CD20 monoclonal antibodies for any reason in the past 12 months
- Has received monoclonal antibodies to treat a previous COVID-19 event
- Pregnant at screening
- Positive SARS-CoV-2 Antigen test in respiratory specimen at screening
- Planning to migrate out of the study area within 6 months of the enrollment
- Participants currently enrolled in any other COVID-19 vaccine research trial in which they are getting a COVID-19 vaccine during the study period
- Illiterate individuals (Brazil only)
- Has a severe and/or uncontrolled comorbidity
- Pakistan (natural infection Priming Group (Priming Group 3-P)):
- ● Prior vaccination with ANY vaccine against COVID-19
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2024
Estimated Enrollment :
2354 Patients enrolled
Trial Details
Trial ID
NCT05343871
Start Date
July 5 2022
End Date
January 11 2024
Last Update
January 30 2024
Active Locations (2)
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1
FIOCRUZ
Campo Grande, MS Do Sul, Brazil
2
Aga Khan University Clinical Trials Unit
Karachi, Sindh, Pakistan