An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity
Infectious Disease, Yellow Fever, Japanese Encephalitis
About this trial
This is an interventional basic science trial for Infectious Disease focused on measuring Yellow Fever, Japanese Encephalitis, YF17D, JE-YF17D, T-cell Immunity, Cellular Immunity, Live-attenuated Vaccines
Eligibility Criteria
Inclusion Criteria:
- Healthy adults, 21-45 years of age at time of screening
- Willing to comply to study procedures and adhere to study schedule visits.
- 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.
- 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 child bearing potential with negative urine pregnancy tests on the day of screening and vaccination.
- 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 Criteria:
- History of presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, haematological, endocrine or immunosuppressive disorders that would be a risk factor when administered the investigational product (IP)
- Previous receipt of Imojev, Stamaril or Ixiaro vaccines, or any other yellow fever or Japanese encephalitis vaccines
- Previous history of Yellow fever virus or Japanese encephalitis infection
- Known allergy to Imojev, Stamaril or Ixiaro vaccines or their components
- 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
- 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 systemic steroids) in the past 7 days.
- Receipt of any licensed vaccine in the past 30 days before the first study vaccine dose.
- Positive serum Dengue IgG by ELISA
- Any condition that, in the opinion of the investigator, would complicate or compromise the study or wellbeing of the subject.
Sites / Locations
- SingHealth Investigational Medicine UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm 1 (JE-YF17D vaccine followed by YF17D vaccine)
Arm 2 (YF17D vaccine followed by JE-YF17D vaccine)
Arm 3 (Inactivated JE vaccine followed by YF17D vaccine)
28 subjects will receive one dose of the JE-YF17D vaccine (Imojev, Sanofi Pasteur, 0.5mls (4.0 - 5.8 log plaque forming units [PFU])) on Day 0 followed by one dose of the YF17D vaccine (Stamaril, Sanofi Pasteur, 0.5mls (3 - 4 log PFU) ) on Day 28.
28 subjects will receive one dose of the YF17D vaccine (Stamaril, Sanofi Pasteur, 0.5mls (3 - 4 log PFU)) on Day 0 followed by one dose of the JE-YF17D vaccine (Imojev, Sanofi Pasteur, 0.5mls (4.0 - 5.8 log plaque forming units [PFU]) on Day 28.
14 subjects will receive one dose of the inactivated JE vaccine (Ixiaro, Valneva, 0.5mls) on Day 0 followed by one dose of the YF17D vaccine (Stamaril, Sanofi Pasteur, 0.5mls (3 - 4 log PFU)) on Day 28.