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TerminatedNCT05252910CoVacSpecUpdated Apr 5, 2022

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

An observational study in COVID-19, sponsored by Pharm-Olam, LLC. Terminated at 32 sites in 7 countries. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Pharm-Olam, LLC · Observational

Why this study was terminated
Global spread of SARS-CoV-2 Omicron variant and vaccination preclude ability to enroll sufficient SARS-CoV-2 seronegative participants.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
33
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • COVID-19

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Keywords

  • Coronavirus Disease 2019 (COVID-19)
  • Specimen collection
  • Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2)
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 33 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Pharm-Olam, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
33 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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.

    Time frame: 12 months (1 year)

07

Study locations

32 sites
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
  • Meharry Medical College/Meharry Medical Center
    Nashville, Tennessee 37208, United States
  • Pan American Clinical Research LLC
    Brownsville, Texas 78520, United States
  • Clinical Trials of Texas, LLC
    San Antonio, Texas 78229, United States
  • Clinisalud
    Envigado, Antioquia, Colombia
  • Bluecare Salud SAS
    Bogotá, Columbia, Colombia
  • Servimed SAS
    Bucaramanga, Santander, 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, Mexico
  • CAIMED Center at the Ponce School of Medicine
    Ponce, 00716, 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05252910
Lead sponsor
Pharm-Olam, LLC
Collaborators
Biomedical Advanced Research and Development Authority
Responsible party
Sponsor
First posted
Feb 23, 2022
Start date
Jan 1, 2022
Primary completion
Mar 4, 2022
Completion
Mar 4, 2022
Last update
Apr 5, 2022

Study contacts

Kelly McKee, MD
principal investigator · Pharm-Olam, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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