COVID-19CoVacSpecNCT05252910
Specimen Collection Study From Coronavirus Disease 2019 (COVID-19) Vaccinated Adults and Adolescents
An observational study of COVID-19, run by Pharm-Olam, LLC at 32 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 33 participants
- Where
- 32 sitesin 7 countries
- Study dates
- 1 Jan 2022to 4 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
South Africa13 sites
Worthwhile Clinical Trials
Benoni, Gauteng
REIMED Wilhase Practice
Boksburg, Gauteng
Langeberg Clinical Trials
Cape Town, Western Cape
Task Applied Science
Cape Town, Western Cape
DR P J Sebastian Clinical Research Centre
Durban, KwaZulu-Natal
Synapta Clinical Research Centre
Durban, KwaZulu-Natal
Clinresco Centres
Kempton Park, Gauteng
Aurum Klerksdorp CRS
Klerksdorp, North West
Clinical Research Institute of South Africa (CRISA)
KwaDukuza, KwaZulu-Natal
Larisha Pillay-Ramaya
Pretoria, Gauteng
Muhammed Ameen Fulat
Pretoria, Gauteng
The Aurum Institute, Rustenburg Clinical Research Site
Rustenburg, North West
Johan Geldenhuys
Vereeniging, Gauteng
India7 sites
Government Medical College & Hospital
Chhatrapati Sambhajinagar, Maharashtra
Peerless Hospitex Hospital
Kolkata, West Bengal
Govt. Medical College
Nagpur, Maharashtra
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra
Unity Hospital
Surat, Gujarat
GMERS Medical College & Hospital
Vadodara, Gujarat
Andhra Medical College
Visakhapatnam, Andhra Pradesh
United States6 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Pan American Clinical Research LLC
Brownsville, Texas, 78520
Meharry Medical College/Meharry Medical Center
Nashville, Tennessee, 37208
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
SUNY Upstate Medical University
Syracuse, New York, 13210
Colombia3 sites
Bluecare Salud SAS
Bogotá, Columbia
Servimed SAS
Bucaramanga, Santander Department
Clinisalud
Envigado, Antioquia
Puerto Rico1 site
CAIMED Center at the Ponce School of Medicine
Ponce, 00716
About this study
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
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.
- Conditions
- COVID-19
- Keywords
- Coronavirus Disease 2019 (COVID-19), Specimen collection, Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2)
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2022
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Why it stopped: Global spread of SARS-CoV-2 Omicron variant and vaccination preclude ability to enroll sufficient SARS-CoV-2 seronegative participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharm-Olam, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Kelly McKee, MD, Principal investigator, Pharm-Olam, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252910
- Sponsor's protocol ID
- 2021SPEC-001
- Acronym
- CoVacSpec
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05252910
- Acronym / sponsor ID
- CoVacSpec / 2021SPEC-001
- Conditions
- COVID-19
- Keywords
- Coronavirus Disease 2019 (COVID-19), Specimen collection, Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Global spread of SARS-CoV-2 Omicron variant and vaccination preclude ability to enroll sufficient SARS-CoV-2 seronegative participants.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pharm-Olam, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specimen Collection
Time frame: 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.
Results and safety
The study was stopped early (reason given: Global spread of SARS-CoV-2 Omicron variant and vaccination preclude ability to enroll sufficient SARS-CoV-2 seronegative participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly McKee, MD principal investigator
Pharm-Olam, LLC
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Pharm-Olam, LLC at 32 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in South Africa, India, United States, Colombia, Guadeloupe and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Global spread of SARS-CoV-2 Omicron variant and vaccination preclude ability to enroll sufficient SARS-CoV-2 seronegative participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specimen Collection (time frame: 12 months (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.