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
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.
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.
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 →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.
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).
For individuals willing to undergo leukapheresis procedure(s), Adults ≥18 years, and adolescents ≥12-17 years must meet the following minimum criteria:
Exclusion Criteria:
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)
Plan to share: No
No publications or documents are linked to this record.
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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