A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
- Conditions
- E. coli infectioninvasive extraintestinal pathogenic E. coli (ExPEC) disease10004018
- Registration Number
- NL-OMON52538
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Solicited local and systemic AEs collected for 14 days post-vaccination<br /><br>(Solicited (local and systemic) AEs are precisely defined events that<br /><br>participants are specifically asked about and which are noted by participants<br /><br>through the participant ediary)<br /><br><br /><br>Unsolicited AEs collected from the administration of the study vaccine until 29<br /><br>days post-vaccination<br /><br>(Unsolicited AEs are all AEs for which the participant is not specifically<br /><br>questioned in the participantediary).<br /><br><br /><br>SAEs collected from the administration of the study vaccineuntil Day 181<br /><br><br /><br>Antibody titers for ExPEC10V, as determined by multiplex ECL-based<br /><br>immunoassayand MOPA on Day 30</p><br>
- Secondary Outcome Measures
Name Time Method <p>Antibody titers for ExPEC10V, as determined by multiplex ECL-based<br /><br>immunoassayand MOPA on Day30<br /><br>Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay<br /><br>on Days15 and 181 and MOPA on Day 181<br /><br>SAEs related to the study vaccine or study procedures collected from Day 182<br /><br>until the end of the study<br /><br>Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay<br /><br>and MOPA at Year 1 (Day 366)</p><br>