- To identify healthy volunteers that are able and willing to participate in future vaccine trials.- To install a pool of healthy volunteers ready to participate in vaccine research for infectious diseases.- To accelerate the set- up phase and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Testing health status
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint of this study is to install a pool of healthy volunteers who
are eligible and ready to participate in vaccine trials.
Secondary outcome
N.a.
Background summary
Vaccines are considered to be the best defence against emerging infectious
diseases; however, the development of new vaccine is a lengthy process. In
December 2019 the outbreak of the novel coronavirus (SARS-CoV-2) and earlier
outbreaks of viruses such as SARS, MERS and Ebola have demonstrated that there
is a societal responsibility to accelerate clinical vaccine development.
After vaccine discovery and preclinical research, new vaccines need to be
tested in healthy volunteers to assess immunogenicity, safety, and
tolerability. Clinical trials are considered the rate-limiting step in vaccine
development. Normally, several months may be required for the set-up of a
first-in-human vaccine trial with a new vaccine. We simply cannot afford to
take this long to prepare the society for future emergencies caused by
infectious diseases. It is therefore of essence to develop novel vaccines
against rising infectious diseases rapidly.
To reduce the start-up time of first-in-human trials in outbreak setting and
accelerate early clinical vaccine trial development, we propose a study to
identify eligible healthy volunteers that could participate in future vaccine
trials and/or are willing to donate blood for (preclinical) vaccine research
purposes. We suggest installing a dedicated pool of healthy volunteers who are
available and ready to be enrolled and dosed within a short period of time.
Thus, CHDR will maintain a pre-screened pool of eligible healthy volunteers,
ready to participate in a clinical vaccine trial at any moment thereby
enhancing pandemic preparedness. This approach will lead to important
reductions in time to protect the general public against the global spread of
infectious diseases such as SARS-CoV-2, and also other emerging infectious
diseases.
The key concept to install the pool of healthy volunteers ready for vaccine
trials is described in this protocol. Furthermore, the objective of the beReady
protocol is also to make it possible to screen for community*s background
immunity that is often required for setting up future vaccine trials or for the
validation of controlled human infection models (CHIMs) to evaluate vaccine*s
efficacy.
Yet, no details on the future investigational vaccine are available and are
therefore not described in this protocol. At the time of a vaccine trial to be
executed, a detailed clinical study protocol will be written and submitted for
ethical review together with the necessary (updated) research files. The
'beReady volunteers* have the opportunity to participate in a future study
under a dedicated informed consent document to be written.
Study objective
- To identify healthy volunteers that are able and willing to participate in
future vaccine trials.
- To install a pool of healthy volunteers ready to participate in vaccine
research for infectious diseases.
- To accelerate the set- up phase and ultimately the overall time to complete
vaccine trials.
- To screen for background immunity for certain pathogens, required for the
purpose of setting up future vaccines studies or for the validation of
CHIMs, necessary to evaluate vaccine*s efficacy.
Study design
This is a program to recruit healthy volunteers, assess their eligibility and
install a cohort of eligible candidates prior to enrollment into a vaccine
trial. The study is designed to facilitate rapid set-up of a clinical vaccine
trial, by asking healthy volunteers to be on a stand-by mode in case of an
urgent outbreak/pandemic. The beReady study will make it possible to screen for
background immunity for certain pathogens by taking serum samples of beReady
subjects for antibody analysis. Assessing the background immunity in the
population may be necessary for setting up future vaccine trials of for the
validation of controlled human infection models.
This study has three parts depending on what information is needed for a
future clinical vaccine study: The three parts are described below. Volunteers
will always participate in Part 1. Part 2 and 3 will only be operational if
more information on general health status is required or blood samples are
needed.
- Part 1: a questionnaire regarding general medical status will be sent per
e-mail to volunteers that are interested to take part in the beReady pool.
- Part 2: if required, a medical staff member of CHDR will contact the
participants who showed interest in participation for additional questions
regarding medical history and general health status.
- Part 3: ambulant visit to CHDR for serum sample collection (i.e. including
but not limited to antibody titers for - for example - screening for background
immunity), not exceeding 100 mL per blood donation and/or screening activities
including, but not limited to, physical examination, BMI and blood sample for
safety lab
To take part in the beReady pool, subjects should give consent for all parts.
Participants will be asked to contact CHDR if there are changes in their health
status. Subjects give consent for a period of five years, hereafter the consent
recedes. In case of prolongation a new informed consent will be signed.
Study burden and risks
The subjects will be asked to participate in an investigational vaccine study.
This option is voluntary.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002014-40-NL |
| CCMO | NL73866.000.20 |