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

COVID-19 Clinical Trial

— CoVacSpec  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05252910
• Other study ID #: 2021SPEC-001
• Status: Terminated
• Start date: January 1, 2022
• Est. completion date: March 4, 2022

Study information

• Verified date: March 2022
• Source: Pharm-Olam, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pharm-Olam, LLC	Biomedical Advanced Research and Development Authority

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)