Clinical trial NCT05252910: Specimen Collection Study From Coronavirus Disease 2019 (COVID-19) Vaccinated Adults and Adolescents
Official title: Collection of Specimens From Adult and Adolescent Participants ≥12 Years Old Who Will Receive an Authorized or Licensed COVID-19 Vaccine as Part of Usual Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19
Keywords: Coronavirus Disease 2019 (COVID-19)
Specimen collection
Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2)
Lead sponsor: Pharm-Olam, LLC
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2022-02-23
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Specimen Collection
timeFrame: 12 months (1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Nashville
country: United States
facility: Meharry Medical College/Meharry Medical Center
state: Tennessee
city: Brownsville
country: United States
facility: Pan American Clinical Research LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: Envigado
country: Colombia
facility: Clinisalud
state: Antioquia
city: Bogotá
country: Colombia
facility: Bluecare Salud SAS
state: Columbia
city: Bucaramanga
country: Colombia
facility: Servimed SAS
state: Santander
city: Les Abymes
country: Guadeloupe
facility: University Hospital Center of Guadeloupe
city: Visakhapatnam
country: India
facility: Andhra Medical College
state: Andhra Pradesh
city: Surat
country: India
facility: Unity Hospital
state: Gujarat
city: Vadodara
country: India
facility: GMERS Medical College & Hospital
state: Gujarat
city: Aurangabad
country: India
facility: Government Medical College & Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Govt. Medical College
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation Ruby Hall Clinic
state: Maharashtra
city: Kolkata
country: India
facility: Peerless Hospitex Hospital
state: West Bengal
city: Chihuahua
country: Mexico
facility: Icaro Investigaciones en Medicina SA de CV
city: Ponce
country: Puerto Rico
facility: CAIMED Center at the Ponce School of Medicine
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Boksburg
country: South Africa
facility: REIMED Wilhase Practice
state: Gauteng
city: Kempton Park
country: South Africa
facility: Clinresco Centres
state: Gauteng
city: Pretoria
country: South Africa
facility: Larisha Pillay-Ramaya
state: Gauteng
city: Pretoria
country: South Africa
facility: Muhammed Ameen Fulat
state: Gauteng
city: Vereeniging
country: South Africa
facility: Johan Geldenhuys
state: Gauteng
city: Durban
country: South Africa
facility: DR P J Sebastian Clinical Research Centre
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
state: KwaZulu-Natal
city: KwaDukuza
country: South Africa
facility: Clinical Research Institute of South Africa (CRISA)
state: Kwazulu-Natal
city: Klerksdorp
country: South Africa
facility: Aurum Klerksdorp CRS
state: North-West
city: Rustenburg
country: South Africa
facility: The Aurum Institute, Rustenburg Clinical Research Site
state: North-West
city: Cape Town
country: South Africa
facility: Langeberg Clinical Trials
state: Western Cape
city: Cape Town
country: South Africa
facility: Task Applied Science
state: Western Cape
Study officials:
affiliation: Pharm-Olam, LLC
name: Kelly McKee, MD
role: PRINCIPAL_INVESTIGATOR
References: