Specimen Collection Study From Coronavirus Disease 2019 (COVID-19) Vaccinated Adults and Adolescents

Stopped early

Conditions studied: COVID-19

In brief

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 years old who will receive locally authorized or licensed COVID-19 vaccines. Approximately 1,000 participants will be enrolled. Plasma and peripheral blood mononuclear cell samples will be obtained either by venipuncture, or by leukapheresis. Serum, RNA, and DNA samples will be obtained by venipuncture. Specimens for mucosal antibody assessments will be collected by nasal swabbing. Biological specimens will be collected from study participants at Baseline prior to the COVID-19 vaccine dose and at timepoints aligned with the study participant's vaccination schedule for a period of up to 1 year following receipt of the initial COVID-19 vaccination.

Key facts

Study ID

NCT05252910

Run by

Pharm-Olam, LLC

People needed

33

Starts

2022-01-01

Expected to finish

2022-03-04

Last updated by the study team

2022-04-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• SUNY Upstate Medical University — Syracuse, New York, United States
• Meharry Medical College/Meharry Medical Center — Nashville, Tennessee, United States
• Pan American Clinical Research LLC — Brownsville, Texas, United States
• Clinical Trials of Texas, LLC — San Antonio, Texas, United States
• Clinisalud — Envigado, Antioquia, Colombia
• Bluecare Salud SAS — Bogotá, Columbia, Colombia
• Servimed SAS — Bucaramanga, Santander Department, Colombia
• University Hospital Center of Guadeloupe — Les Abymes, Guadeloupe
• Andhra Medical College — Visakhapatnam, Andhra Pradesh, India
• Unity Hospital — Surat, Gujarat, India
• GMERS Medical College & Hospital — Vadodara, Gujarat, India
• Government Medical College & Hospital — Aurangabad, Maharashtra, India
• Govt. Medical College — Nagpur, Maharashtra, India
• Grant Medical Foundation Ruby Hall Clinic — Pune, Maharashtra, India
• Peerless Hospitex Hospital — Kolkata, West Bengal, India
• Icaro Investigaciones en Medicina SA de CV — Chihuahua City, Mexico
• CAIMED Center at the Ponce School of Medicine — Ponce, Puerto Rico
• Worthwhile Clinical Trials — Benoni, Gauteng, South Africa
• REIMED Wilhase Practice — Boksburg, Gauteng, South Africa
• Clinresco Centres — Kempton Park, Gauteng, South Africa
• Larisha Pillay-Ramaya — Pretoria, Gauteng, South Africa
• Muhammed Ameen Fulat — Pretoria, Gauteng, South Africa
• Johan Geldenhuys — Vereeniging, Gauteng, South Africa
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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