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Lake Nona Research Group Clinical Trial Study for Burden and Impact of Reactogenicity Among Adults Receiving COVID-19 Vaccines in Orlando, FL
This research involves completing a short, electronic web-based survey each day for 7 days. If you choose to participate, you will be asked to complete a survey during your visit today that asks general questions about your overall health, your experiences with COVID-19, and brief background questions. Your email address is required to participate in the survey so that the assigned research staff/team member can send you links via email to complete the daily surveys.
Phase: I
Health Conditions: Healthy Volunteers Studies
Reference #: 2019nCOV-406
Sponsored by: Lake Nona Research Group
Stipend: $175
Length of Study: 1 Week
Additional Qualifying Information / Important Inclusions or Exclusions:
Gender: Both
Age: 18 – 100
Washout Period: 30 Days from
In-patient or stay overnight at the research center? No
Adults ≥ 18 years old and ≤ 65 years old
Receiving their first, second, first or second booster dose of Comirnaty, Spikevax, J&J COVID-19 vaccine or NVX-CoV2373in US or receiving their first, second, first or second booster dose of Comirnaty, Spikevax, J&J COVID-19 vaccine, NVX- CoV2373Vaxzevria, or Covifenz in Canada.
Able to understand and provide informed consent
Employed (and working for pay) at least 20 hours per week and scheduled to work at
least 3 days in the 6 days after vaccination (e.g., not on vacation or scheduled leave)
Able to read English or Spanish (US) or able to read English or French (Canada)
Able and willing to comply with all study requirements
Access to a smartphone, tablet, or computer to complete the daily study
Participation in research involving an investigational product (drug or biologic or device) within 45 days prior to the study vaccination.
Any confirmed or suspected immunocompromised condition including active cancer and chronic administration (defined as more than 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days).
Lake Nona Research Group
115 E Lancaster Rd Unit A, Orlando, FL 32809, USA
Lake Nona Research Group
Study Scavenger Provides the Below Helpful Information
In-Patient/Out-Patient Explained
There are two main reasons clinical research trials are done in an isolated inpatient setting where the patient stays overnight at a research clinic: 1) To protect the study participant: Some study agents, usually challenge products, can make some people quite sick. Study participants stay on the inpatient unit to receive 24 hour nursing care during these types of studies. Participants stay on the isolation unit until their laboratory test show they are no longer shedding the infectious agent. 2) To protect the public: An infectious study agent that is given to a study participant may be harmful to the general public’s health. Therefore, study participants stay on the inpatient unit until the possibility of giving the infection to someone else has passed.
An outpatient vaccine trial is a study that does not require an overnight stay in the hospital or research clinic. Participants are given an investigational agent and have scheduled clinic visits to monitor how well they tolerate the investigational agent. Most studies require the clinic staff to follow up with subjects on a daily, weekly or monthly schedule. Clinic visits can range from 2 to 4 hours, depending on the study and the type of visit. – National Institute of Health
Screening Visit
Screening Visit: Potential candidates for a Study will participate in an initial screening visit to determine if they are appropriate for the Study. When you first attend the screening visit for phases I-III, the study is explained in detail and you can ask any questions. If you decide to participate, the study nurse will review the informed consent form with you and ask for your signature and permission to proceed with the screening evaluations. – – National Institute of Health
Washout Period Explained
A period during a clinical trial when the trial subjects receive no active medication. The wash-out period is typically used to generate patient baseline data. Every clinic has a washout period during which you are not allowed to do a study at the same clinic or any other clinic.
The minimum period is 30 days since last dose, however some washouts go based on last study procedure (such as out patient visits or how much blood you gave during the study). The washout period may vary from study to study depending on the half-life of the drug. Certain studies like radio-labeled drugs will have a 1 year washout before you can do another radio-labeled drug. In addition to the clinic’s washout policy, the sponsor may impose a longer washout period. Some studies will have a longer washout before you can sign up.
In general, you can sign up and screen for another study during the washout period as long as the check in date is at least 30 days after your last dose in the previous study. However, depending on how fast your body recovers from a study, you may want to wait the full period to avoid problems with screening.
People who screen too soon after a study typically have lower red blood cell, hemoglobin, hematocritand iron. If these levels are too low, you could get banned from participating in studies because having low levels is unhealthy and unsafe for participating in a study.
Be forewarned that many clinic participate in the VCT (Verified Clinical Trials) program which tracks when you do a study to ensure the next study meets washout periods. I do not mention these clinics because it shouldn’t matter. You know the rules and if you break them, the consequences can be dire like being banned from a clinic. Sometimes the only way to drive this message home is to allow people to find out the hard way. – – National Institute of Health