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

NCT05252910 | Terminated

• 1 other identifier: 2021SPEC-001
• Study Type: observational
• Target: 33
• Locations: 7 countries
• Sites: 32

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.

Conditions

COVID-19

Keywords

Coronavirus Disease 2019 (COVID-19); Specimen collection; Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2)

Outcome Measures

Primary Outcomes (1)

• Specimen Collection

  This study is designed to collect biological specimens/samples to generate a biological specimen repository of samples from severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) naïve adults and adolescent participants ≥12 years old who will be receiving, as a matter of care, locally authorized or licensed Coronavirus Disease 2019 (COVID-19) vaccines whose development has been supported by the US Government. Specimens collected with associated metadata will be shared with the US Government and stakeholders.

  12 months (1 year)

Eligibility Criteria

• Age: 12 Years+
• Gender Eligibility Details: Males or non-pregnant (by participant report) females
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of subjects meeting the inclusion/exclusion criteria who are SARS-CoV-2 naïve adults and adolescents ≥12 years old who will receive locally authorized or licensed COVID-19 vaccines. All subjects must be willing to assent/sign the informed consent and undergo venipuncture, nasal swab collection, and leukapheresis (where allowed and subject agrees).

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.

Sponsors & Collaborators

• Pharm-Olam, LLC: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (32)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Meharry Medical College/Meharry Medical Center

Nashville, Tennessee, 37208, United States

Location

Pan American Clinical Research LLC

Brownsville, Texas, 78520, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Clinisalud

Envigado, Antioquia, Colombia

Location

Bluecare Salud SAS

Bogotá, Columbia, Colombia

Location

Servimed SAS

Bucaramanga, Santander Department, Colombia

Location

University Hospital Center of Guadeloupe

Les Abymes, Guadeloupe

Location

Andhra Medical College

Visakhapatnam, Andhra Pradesh, India

Location

Unity Hospital

Surat, Gujarat, India

Location

GMERS Medical College & Hospital

Vadodara, Gujarat, India

Location

Government Medical College & Hospital

Aurangabad, Maharashtra, India

Location

Govt. Medical College

Nagpur, Maharashtra, India

Location

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, India

Location

Peerless Hospitex Hospital

Kolkata, West Bengal, India

Location

Icaro Investigaciones en Medicina SA de CV

Chihuahua City, Mexico

Location

CAIMED Center at the Ponce School of Medicine

Ponce, 00716, Puerto Rico

Location

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

Location

REIMED Wilhase Practice

Boksburg, Gauteng, South Africa

Location

Clinresco Centres

Kempton Park, Gauteng, South Africa

Location

Larisha Pillay-Ramaya

Pretoria, Gauteng, South Africa

Location

Muhammed Ameen Fulat

Pretoria, Gauteng, South Africa

Location

Johan Geldenhuys

Vereeniging, Gauteng, South Africa

Location

DR P J Sebastian Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

Location

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

Location

Clinical Research Institute of South Africa (CRISA)

KwaDukuza, KwaZulu-Natal, South Africa

Location

Aurum Klerksdorp CRS

Klerksdorp, North West, South Africa

Location

The Aurum Institute, Rustenburg Clinical Research Site

Rustenburg, North West, South Africa

Location

Langeberg Clinical Trials

Cape Town, Western Cape, South Africa

Location

Task Applied Science

Cape Town, Western Cape, South Africa

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, peripheral blood mononuclear cells, serum, RNA, DNA, and nasal mucosa.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kelly McKee, MD

  Pharm-Olam, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 23, 2022
• Study Start: January 1, 2022
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (13); IN (7); ME (1); US (6); CO (3); GU (1); PR (1)