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

Sponsor

Pharm-Olam, LLC (Industry)

Overall Status

Terminated

CT.gov ID

NCT05252910

Collaborator

Biomedical Advanced Research and Development Authority (U.S. Fed)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19

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.

Study Design

Study Type:

Observational

Actual Enrollment :

33 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Mar 4, 2022

Actual Study Completion Date :

Mar 4, 2022

Outcome Measures

Primary Outcome Measures

Specimen Collection [12 months (1 year)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
3	SUNY Upstate Medical University	Syracuse	New York	United States	13210
4	Meharry Medical College/Meharry Medical Center	Nashville	Tennessee	United States	37208
5	Pan American Clinical Research LLC	Brownsville	Texas	United States	78520
6	Clinical Trials of Texas, LLC	San Antonio	Texas	United States	78229
7	Clinisalud	Envigado	Antioquia	Colombia
8	Bluecare Salud SAS	Bogotá	Columbia	Colombia
9	Servimed SAS	Bucaramanga	Santander	Colombia
10	University Hospital Center of Guadeloupe	Les Abymes		Guadeloupe
11	Andhra Medical College	Visakhapatnam	Andhra Pradesh	India
12	Unity Hospital	Surat	Gujarat	India
13	GMERS Medical College & Hospital	Vadodara	Gujarat	India
14	Government Medical College & Hospital	Aurangabad	Maharashtra	India
15	Govt. Medical College	Nagpur	Maharashtra	India
16	Grant Medical Foundation Ruby Hall Clinic	Pune	Maharashtra	India
17	Peerless Hospitex Hospital	Kolkata	West Bengal	India
18	Icaro Investigaciones en Medicina SA de CV	Chihuahua		Mexico
19	CAIMED Center at the Ponce School of Medicine	Ponce		Puerto Rico	00716
20	Worthwhile Clinical Trials	Benoni	Gauteng	South Africa
21	REIMED Wilhase Practice	Boksburg	Gauteng	South Africa
22	Clinresco Centres	Kempton Park	Gauteng	South Africa
23	Larisha Pillay-Ramaya	Pretoria	Gauteng	South Africa
24	Muhammed Ameen Fulat	Pretoria	Gauteng	South Africa
25	Johan Geldenhuys	Vereeniging	Gauteng	South Africa
26	DR P J Sebastian Clinical Research Centre	Durban	KwaZulu-Natal	South Africa
27	Synapta Clinical Research Centre	Durban	KwaZulu-Natal	South Africa
28	Clinical Research Institute of South Africa (CRISA)	KwaDukuza	Kwazulu-Natal	South Africa
29	Aurum Klerksdorp CRS	Klerksdorp	North-West	South Africa
30	The Aurum Institute, Rustenburg Clinical Research Site	Rustenburg	North-West	South Africa
31	Langeberg Clinical Trials	Cape Town	Western Cape	South Africa
32	Task Applied Science	Cape Town	Western Cape	South Africa

Sponsors and Collaborators

Pharm-Olam, LLC
Biomedical Advanced Research and Development Authority

Investigators

Principal Investigator: Kelly McKee, MD, Pharm-Olam, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pharm-Olam, LLC

ClinicalTrials.gov Identifier:

NCT05252910

Other Study ID Numbers:

2021SPEC-001

First Posted:

Feb 23, 2022

Last Update Posted:

Apr 5, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pharm-Olam, LLC

Coronavirus Disease 2019 (COVID-19)

Specimen collection

Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2)

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 5, 2022