- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343871
Immunogenicity and Safety of Fractional Booster Dose of COVID-19 Vaccines Available for Use in Pakistan/Brazil: A Phase 4 Dose-optimizing Trial
Randomized Controlled Trial to Assess the Immunogenicity and Safety of Full Versus Fractional Dose of Pfizer/BioNTech, AstraZeneca, and Sinovac COVID-19 Vaccines Given as a Booster Dose at Least 6 Months After Primary Vaccination Series or PCR-confirmed Infection With SARS-CoV-2 in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Denise Garrett, MD
- Phone Number: +1 202 842 5025
- Email: sabin@sabin.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Priming Group 1: Sinovac Prime, BNT162b2 1/3 dose
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Experimental: Priming Group 1: Sinovac Prime, BNT162b2 1/2 dose
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Active Comparator: Priming Group 1: Sinovac Prime, BNT162b2 full dose
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Active Comparator: Priming Group 1: Sinovac Prime, Sinovac full dose
|
Sinovac inactivated COVID-19 vaccine: ● Full dose (0.5 ml) |
Experimental: Priming Group 2: AZD1222 Prime, BNT162b2 1/3 dose
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Experimental: Priming Group 2: AZD1222 Prime, BNT162b2 1/2 dose
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Active Comparator: Priming Group 2: AZD1222 Prime, BNT162b2 full dose
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Experimental: Priming Group 3-B: BNT162b2 Prime, AZD1222 ½ dose (Brazil only)
|
AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine:
|
Active Comparator: Priming Group 3-B: BNT162b2 Prime, AZD1222 full dose (Brazil only)
|
AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine:
|
Experimental: Priming Group 3-B: BNT162b2 Prime, BNT162b2 1/3 dose (Brazil only)
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Experimental: Priming Group 3-B: BNT162b2 Prime, BNT162b2 1/2 dose (Brazil only)
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Active Comparator: Priming Group 3-B: BNT162b2 Prime, BNT162b2 full dose (Brazil only)
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Experimental: Priming Group 3-P: Natural Infection Prime, BNT162b2 1/3 dose (Pakistan only)
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Experimental: Priming Group 3-P: Natural Infection Prime, BNT162b2 1/2 dose (Pakistan only)
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Active Comparator: Priming Group 3-P: Natural Infection Prime, BNT162b2 full dose (Pakistan only)
|
Pfizer/BioNTech BNT162b2 mRNA vaccine:
|
Experimental: Priming Group 1: Sinovac Prime, AZD1222 ½ dose (Brazil only)
|
AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine:
|
Active Comparator: Priming Group 1: Sinovac Prime, AZD1222 full dose (Brazil only)
|
AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine:
|
Experimental: Priming Group 2: AZD1222 Prime, AZD1222 ½ dose (Brazil only)
|
AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine:
|
Active Comparator: Priming Group 2: AZD1222 Prime, AZD1222 full dose (Brazil only)
|
AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sero-response rate by Spike IgG binding ELISA at 28 days post booster
Time Frame: Day 28
|
Assess and compare humoral immune response from a fractional vs. full booster dose of BNT162b2 or AZD1222 in immunocompetent adults fully primed with BNT162b2, AZD1222, or Sinovac vaccines or natural infection, measured by anti-Spike IgG binding ELISA at 28 days post booster
|
Day 28
|
Safety and reactogenicity profile of fractional and full dose of study vaccines at 28 days post-booster vaccination
Time Frame: Day 28
|
Describe the safety and reactogenicity profile of fractional and full dose of study vaccines at 28 days post-booster vaccination through estimated incidence of solicited local and systemic adverse events, and incidence of unsolicited reported adverse events
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sero-response rate by anti-Spike IgG binding ELISA at 3m and 6m post booster
Time Frame: Month 3 and Month 6
|
Assess the persistence of humoral immunity after a fractional vs. full booster dose of BNT162b2 or AZD1222 in immunocompetent adults fully primed with BNT162b2, AZD1222, or Sinovac vaccines or natural infection, measured by anti-Spike IgG binding ELISA at 3m and 6m post booster
|
Month 3 and Month 6
|
Safety and reactogenicity profile of fractional and full dose of study vaccines throughout the trial
Time Frame: Throughout study, 6 months per participant
|
Describe the safety and reactogenicity profile of fractional and full dose of study vaccines throughout the trial
|
Throughout study, 6 months per participant
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sabin CoV 22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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