Status:
TERMINATED
Specimen Collection Study From Coronavirus Disease 2019 (COVID-19) Vaccinated Adults and Adolescents
Lead Sponsor:
Pharm-Olam, LLC
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Brief Summary
This is a specimen collection study intended to generate a biological specimen repository of samples from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) naïve adults and adolescents ≥12 ...
Detailed Description
This specimen collection study will generate a bank of biological specimens/samples and associated meta data from severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) naïve adults and adolesce...
Eligibility Criteria
Inclusion
- Male or non-pregnant (by participant report) female adults (≥18 years or older) or adolescents (≥12 years old and \<18 years old) in generally good health, who will receive a locally licensed or authorized COVID-19 vaccine, development of which was supported by the United States Government, as part of standard preventive medical care.
- Able to understand and sign the Informed Consent Form (for adolescent participants informed consent form from parent and participant assent).
- Participants with some medical conditions that might otherwise disqualify them from routine blood or blood component donations, such as HIV/AIDS, diabetes mellitus, etc., can participate if their conditions are stable, well-controlled, have had no change in clinical status or medication for at least 6 months, and whose participation in the protocol would not present excess risk to the participant as judged by the Investigator.
- Willing to comply with study procedures and schedule for sample collections.
- Available for follow-up visits over the next year.
- For individuals willing to undergo leukapheresis procedure(s), Adults ≥18 years, and adolescents ≥12-17 years must meet the following minimum criteria:
- Weight ≥110 pounds/50 kg
- Platelet count \>150×109/L
- Adequate bilateral antecubital veins to allow for 2 peripheral vein access points.
- At least 2 weeks since any previous blood product donation.
Exclusion
- Prior receipt of any COVID-19 vaccine.
- Anemia at screening, or history of anemia caused by chronic therapies or congenital/genetic conditions (e.g., thalassemia) per participant/parent report. Individuals with histories of anemias that have been remedied with treatment (e.g., parasitism, B12, iron deficiency) are allowed.
- Have a history of intravenous drug abuse.
- Have a history of sickle cell disease per participant/parent report
- Have a history of poorly controlled or clinically significant heart, lung, kidney disease, per participant/parent report and Investigator assessment.
- Have a history of Hepatitis B or C, per participant/parent report. Participants with resolved Hepatitis B or C, or those with no apparent clinical manifestations of these infections, may participate.
- Have a contraindication to phlebotomy (i.e., evidence of cellulitis or abscess; venous thrombosis on palpation; presence of hematoma; presence of vascular shunt, graft, or access device; anti-coagulation therapy; history of bleeding diathesis; or clinically significant thrombocytopenia (platelet count \<150×109/L) as assessed by Investigator, participant/parent report, or screening platelet count.
- Have a history of untreated, unresolved, or recurrent malaria during the preceding 12 months per participant/parent report.
- Have donated blood in the past 8 weeks.
- Have planned surgery in the next 8 weeks.
- Is breast feeding, pregnant, or may be pregnant, per participant report.
- Are currently participating or are planning to participate in any clinical trial, including a COVID-19 vaccine trial or COVID-19 therapeutic trial.
- Any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study.
- Any condition that in the judgement of the Investigator precludes participation because it could adversely affect participant safety or data integrity.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 4 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05252910
Start Date
January 1 2022
End Date
March 4 2022
Last Update
April 5 2022
Active Locations (32)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
3
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
4
Meharry Medical College/Meharry Medical Center
Nashville, Tennessee, United States, 37208