Status:
TERMINATED
The Immunostimulatory Effects of Gentamicin
Lead Sponsor:
Singapore General Hospital
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-50 years
Phase:
PHASE2
Brief Summary
Gentamicin is one of the few aminoglycoside antibiotics which are approved for parenteral use in Singapore. As with other aminoglycosides, gentamicin is primarily bactericidal against Gram-negative or...
Detailed Description
Informed written consent will be sought from subjects who fulfil criteria for enrolment. All consented subjects will undergo screening, which includes physical examination, full blood count, liver fun...
Eligibility Criteria
Inclusion
- Healthy adults, 21-50 years of age at time of screening
- Satisfactory baseline medical assessment as assessed by physical examination and a stable health status. The laboratory values must be within the normal range of the assessing site or show abnormalities that are deemed not clinically significant as judged by the investigator. A stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event.
- Accessible vein for blood collection.
- Subjects who are willing to comply with the requirements of the study protocol and scheduled visits. (e.g. return for follow-up visits) and who are willing to make themselves available for the duration of the study, with access to a consistent means of telephone contact, which may be either at home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device (i.e. a common-use phone serving multiple rooms or apartments).
- Ability to provide informed consent
- Female subjects of non-child bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Post-menopausal subjects must have had at least 12 months of natural (spontaneous) amenorrhea.
- Female subjects of childbearing potential with negative urine pregnancy tests on the day of screening and day of antibiotic administration.
- Both male (if he has a partner of childbearing potential) and female subjects (of childbearing potential) must agree to use adequate and reliable contraceptive measures (e.g. spermicides, condoms, contraceptive pills) or practice abstinence for 10 days after vaccination
Exclusion
- History of presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, haematological, endocrine or immunosuppressive disorders that would be a risk factor when administered gentamicin or YF17D vaccine.
- Previous receipt of YF17D vaccine (stamaril) or any other yellow fever vaccines.
- Previous history of Yellow fever virus infection
- Known allergy to YF17D vaccine (stamaril) or its components
- Known allergy to gentamicin
- History of severe food/drug/vaccine allergies e.g. angioedema, anaphylaxis
- Known allergy to egg or egg products
- History of thymus gland disease
- Diagnosed with cancer or on treatment for cancer (with the exception of localized basal cell carcinoma) within 3 years prior to screening
- Diagnosed with neuromuscular disorders
- Evidence of clinically significant anemia (Hb \<10 g/dl)
- Blood donation exceeding \>450mls in the past 3 months
- Presence of acute infection in the preceding 7 days or presence of a temperature ≥ 38.0°C (oral or tympanic temperature assessment), or acute symptoms greater than of "mild" severity on the scheduled date of first dose
- Woman who is pregnant or breast feeding
- Evidence of substance abuse, or previous substance abuse including alcohol
- Participation in a study involving administration of an investigational compound (including investigational vaccines) within the past three months, or planned participation during the duration of this study.
- Receipt of anti-inflammatory drugs (such as NSAIDs or steroids) in the past 7 days before the first study drug/vaccine dose.
- Receipt of any licensed vaccine in the past 30 days before the first study drug/vaccine dose.
- Any condition that, in the opinion of the investigator, would complicate or compromise the study or wellbeing of the subject.
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05303909
Start Date
May 11 2022
End Date
May 13 2024
Last Update
May 16 2024
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169074