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beReady study: A study to identify potential healthy volunteers eligible for early phase vaccine trials in the context of pandemic preparedness

Not yet recruiting
Conditions
Testing health status
Testing health status to be ready for a vaccine trial
Registration Number
NL-OMON55932
Lead Sponsor
Centre for Human Drug Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
100
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 < 32.0 kg/m2;
3. Willing to stay available and share availability for vaccine trial
participation;
4. Signed informed consent prior to any study- related procedures.

Part 2 (Phone screening):
1. Healthy male or female subjects, >= 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 < 32.0 kg/m2;
3. Willing to stay available and share availability for vaccine trial
participation;
4. Signed informed consent prior to any study- related procedures.

Part 3 (On site screening)
1. Healthy male or female subjects, >= 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 < 32.0 kg/m2;
3. Willing to stay available and share availability for vaccine trial
participation;
4. Signed informed consent prior to any study- related procedures.

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.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary endpoint of this study is to install a pool of healthy volunteers who<br /><br>are eligible and ready to participate in vaccine trials. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>N.a.</p><br>
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