The sites of the Netherlands will only participate in cohort 2. Primary objectives - cohort 2: - To evaluate the safety and reactogenicity of the selected dose of ExPEC10V in participants >=60 years of age with a history of UTI in the past 5…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Solicited local and systemic AEs collected for 14 days post-vaccination
(Solicited (local and systemic) AEs are precisely defined events that
participants are specifically asked about and which are noted by participants
through the participant ediary)
Unsolicited AEs collected from the administration of the study vaccine until 29
days post-vaccination
(Unsolicited AEs are all AEs for which the participant is not specifically
questioned in the participantediary).
SAEs collected from the administration of the study vaccineuntil Day 181
Antibody titers for ExPEC10V, as determined by multiplex ECL-based
immunoassayand MOPA on Day 30
Secondary outcome
Antibody titers for ExPEC10V, as determined by multiplex ECL-based
immunoassayand MOPA on Day30
Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay
on Days15 and 181 and MOPA on Day 181
SAEs related to the study vaccine or study procedures collected from Day 182
until the end of the study
Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay
and MOPA at Year 1 (Day 366)
Background summary
ExPEC10V is a 10-valent vaccine candidate in development for the prevention of
invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease (IED) in
adults 60 years of age and older.
ExPEC are a leading and rising cause of bacteremia and bloodstream infections
worldwide, and comprise17% to 37% of clinically significant blood isolates.
The worldwide emergence of multidrug resistance (ie,resistance to three or more
antibiotic classes) among ExPEC strains represents a major challenge for the
prevention and management of ExPEC infections.
Although IED affects all age categories, adults aged 60 years or older have an
increased risk of developing IED.
At present, there is no vaccine available to prevent IED. ExPEC10V is being
developed to prevent IED in adults 60 years of age and older.
Study objective
The sites of the Netherlands will only participate in cohort 2.
Primary objectives - cohort 2:
- To evaluate the safety and reactogenicity of the selected dose of ExPEC10V in
participants >=60 years of age with a history of UTI in the past 5 years
- To evaluate the immunogenicity of the selected dose of ExPEC10V on Day 30 in
participants >=60 years of age with a history of UTI in the past 5 years
Secondary objectives - cohort 2:
- To evaluate the correlation between multiplex ECL-based immunoassay (total
antibody) and MOPA (functional antibody) serum titers on Day 30
- To evaluate the immunogenicity of the selected dose of ExPEC10V on Days 15
and 181
- To evaluate, in the LTFU period, the safety and immunogenicity of the
selected dose of ExPEC10V
Study design
This is a phase 1 / 2a study to investigate the safety, reactogenicity and
immunogenicity of 3 different doses of the vaccine EXPEC10V in adults 60 - 85
years of age in stable health.
Cohort 1 of this study was conducted in the United States. For Cohort 1, the
primary objective of the study was to evaluate the safety and reactogenicity of
different doses of ExPEC10V.
Cohort 2 will be conducted in the United States and several European countries.
For Cohort 2, the primary objective of the study is to evaluate the safety and
reactogenicity of the selected dose of ExPEC10V from Cohort 1.
Intervention
Cohort 2:
- 1 administration of the study vaccine EXPEC10V (selected dose from cohort 1)
on day 1 of the study.
Study burden and risks
The subjects will not derive any personal health benefits from participating in
this study, but the results obtained from this study may be important for the
development of vaccines and treatments that may be beneficial to the health of
others. For example, their participation can help prevent other people from
getting a urinary tract infection in the future.
Disadvantages of participating in the study may include:
- possible side effects of the study vaccine.
- possible inconveniences of the measurements in the study (e.g. blood tests,
maximum 7 times).
The safety profile of ExPEC10V has not yet been established. However, clinical
data are available for the ExPEC4V vaccine without new safety concerns. The
nature and production processes of ExPEC4V and ExPEC10V are similar. Therefore,
the safety profile of ExPEC10V is expected to be similar to that of ExPEC4V. In
addition, the EXPEC10V vaccine was administered to more than 400 participants
in the previous cohort 1 of this study.
Graaf Engelbertlaan 75
Breda 4837 DS
NL
Graaf Engelbertlaan 75
Breda 4837 DS
NL
Listed location countries
Age
Inclusion criteria
- Must have a body mass index (BMI) of >18.5 to<40kg/m2;
- Before randomization, a woman must be:
a). postmenopausal - A postmenopausal state is defined as no menses for 12
months without an alternative medical cause; or
b). not intending to conceive by any methods;
- Must be healthy or medically stable
- Must sign an ICF indicating that he or she understands the purpose of, and
procedures required for,the study and is willing to participate in the study;
- Willing and able to adhere to the lifestyle restrictions specified in this
protocol
- Agrees not to donate blood until 12 weeks after receiving the study vaccine
Exclusion criteria
- Acute illness (this does not include minor illnesses such as diarrhea or mild
upper respiratory tract infection) or temperature >=38.0ºC (100.4°F) within 24
hours prior to the administration of study vaccine, or, applicable for Cohort 2
only, an ongoing or suspected symptomatic UTI; enrollment at a later date is
permitted (provided the screening window of 28days is respected);
- History of malignancy within 5 years before screening (exceptions are
squamous and basal cell carcinomas of the skin and carcinoma in situ of the
cervix, or malignancy, which is considered cured with minimal risk of
recurrence);
- Known allergies, hypersensitivity, or intolerance to ExPEC10V or its
excipients (refer to Investigator's Brochure);
- Contraindication to IM injections and blood draws eg, bleeding disorders;
- Abnormal function of the immune system
- Has had major psychiatric illness and/or drug substance or alcohol abuse in
the past 12months
Design
Recruitment
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 | EUCTR2020-000657-27-NL |
| ClinicalTrials.gov | NCT03819049 |
| CCMO | NL74093.000.20 |