Testing health status Testing health status to be ready for a vaccine trial
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part 1 (e-mail questionnaire) 1. Healthy male or female subjects, >= 18 years of age; 2. Body mass index (BMI) >= 18.0 and = 18 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical history; 2. Body mass index (BMI) >= 18.0 and = 18 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and history; Subjects 65 years of age and older: in the investigator*s clinical judgment, participant must be either in good or stable health. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19, except for smoking, which is allowed (see also exclusion criterion 6). 2. Body mass index (BMI) >= 18.0 and
Exclusion criteria
Exclusion criteria: Part 1 (e-mail questionnaire): 1. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agent; 2. History of anaphylaxis or other significant adverse event following immunization. Part 2 (Phone screening): 1. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agents; 2. History of anaphylaxis or other significant adverse event following immunization; 3. Evidence of any active or chronic disease or condition that could interfere with, the conduct of a study with a candidate vaccine, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history); 4. Prior receipt of immunoglobulins or vaccinations that is likely to impact interpretation of study outcomes. Part 3 (On site screening) 1. Evidence of any active or chronic disease or condition that could interfere with, the conduct of a study with a candidate, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history); 2. History of anaphylaxis or other significant adverse event following immunization; 3. Prior receipt of immunoglobulins or vaccinations that is likely to impact interpretation of study outcomes; 4. Participation in an investigational drug study; 5. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agent; 6. Heavy smokers who normally consume more than 5 cigarettes a day. Smokers will be defined as any subject who reports tobacco use; 7. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies; 8. History of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bleeding or bruising following intramuscular injections or vena punctures; 9. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to enrollment in the healthy volunteer pool or intention to donate blood or blood products during the stand-by participation in a vaccine trial; 10. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease. Note that not for all future vaccine trials all the above-described exclusion criteria are required. Then, only a subset of exclusion will be taken. No additional assessments than required for the above-described exclusion criteria will be performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of this study is to install a pool of healthy volunteers who are eligible and ready to participate in vaccine trials. | — |
Secondary
| Measure | Time frame |
|---|---|
| N.a. | — |
Countries
Netherlands
Outcome results
None listed