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

NCT ID: NCT05252910

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-03-04

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 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.

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 adolescent participants ≥12 years old who will receive authorized or licensed Coronavirus Disease 2019 (COVID-19) vaccine as a matter of care. The samples may be used to determine immunological responses and microbiologic factors, to develop novel assays, diagnostic tests, therapeutic agents, and vaccines.

Vaccines received by study participants will be only those supported and approved for use by the United States Government, and authorized or licensed for use in the country in which the participant is enrolled. Participants will be receiving COVID-19 vaccine as a matter of standard preventive medical care, and not as a research activity. Participant screening and biological specimen collection will occur only after informed consent/assent. Participants may participate in all, or a part, of this study to provide biological specimens.

Participants who are eligible for the study will be stratified into age groups: ≥12 to <18 years, ≥18 to ≤65 years, >65 years of age. Approximately 1,000 participants will be enrolled in this study.

Biological specimens will be collected from each participant for up to 1 year following receipt of their initial COVID-19 vaccination. Additional participants may be enrolled for up to 2 additional years.

Enrollment dynamics will be actively monitored across all sites, and efforts will be made to balance enrollment by sex, age group, and type of vaccine received. Testing of blood samples obtained from study participants at screening will be performed on an ongoing basis to assess for evidence of prior COVID-19 infection. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serostatus of participants across the program will be actively monitored to target an enrollment of at least 75% seronegative participants for both adult as well as adolescent participants.

Demographic data, height and weight, vaccination details, major past medical history, and comorbidities will be collected at baseline from study participants. Concomitant medications, significant intercurrent medical events, and unanticipated adverse events or problems posing risks to study subjects will be recorded from enrollment through the end of the study for all participants.

There is no analysis plan or primary or secondary endpoints for this specimen collection study. The study will be conducted in accordance with Good Clinical Practices for human research solely for the purpose of generating a repository of serial blood (collected by phlebotomy and leukapheresis) and nasal swab specimens from severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) naïve adults and adolescents ≥12 years old who have received authorized or licensed COVID-19 vaccines.

Samples will be identified only by subject identification number.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Pharm-Olam, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly McKee, MD

Role: PRINCIPAL_INVESTIGATOR

Pharm-Olam, LLC

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

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

DR P J Sebastian Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

Clinical Research Institute of South Africa (CRISA)

KwaDukuza, KwaZulu-Natal, South Africa

Aurum Klerksdorp CRS

Klerksdorp, North West, South Africa

The Aurum Institute, Rustenburg Clinical Research Site

Rustenburg, North West, South Africa

Langeberg Clinical Trials

Cape Town, Western Cape, South Africa

Task Applied Science

Cape Town, Western Cape, South Africa

Countries

United States; Colombia; Guadeloupe; India; Mexico; Puerto Rico; South Africa

Other Identifiers

2021SPEC-001

Identifier Type: -

Identifier Source: org_study_id