Evaluation of the Protective Efficacy of TV003 or Previous Zika Infection Against Infection With ZIKV-SJRP Challenge Compared to DENV and ZIKV-naïve Controls Against Infection With ZIKV-SJRP Challenge

Exclusion Criteria

• •Currently pregnant, as determined by positive beta-human choriogonadotropin (b-hCG) test, breast-feeding, planning to become pregnant during the 12-month duration of the study or planning to donate eggs through 56 days post ZIKV challenge. A careful detailed reproductive and contraception use history will be obtained and the subject will be excluded if the history or clinical record raises concerns related to pregnancy prevention.
• •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
• •Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
• •Evidence of recent opiate use based on urine toxicology screen.
• •Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, and serum creatinine, as defined in this protocol.
• •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
• •Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by subject history.
• •History of a severe allergic reaction or anaphylaxis.
• •Severe asthma (emergency room visit or hospitalization within the last 6 months).
• •HIV infection, by screening and confirmatory assays.
• •Hepatitis C virus (HCV) infection, by screening and confirmatory assays.
• •Hepatitis B virus (HBV) infection, by Hepatitis B surface antigen (HBsAg) screening.
• •History of Guillain-Barré syndrome (GBS).
• •History of seizure disease or peripheral neuropathy.
• •History of any neuroinflammatory disorder, i.e., Bell's Palsy, transverse myelitis.
• •Any known immunodeficiency syndrome, including that caused by malignancy.
• •Use of anticoagulant medications, (use of antiplatelet medication such as aspirin or non-steroidal anti-inflammatory medication is permitted and will not exclude a subject from enrollment).
• •Use of corticosteroids (excluding topical, inhaled, or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. Immunosuppressive dose of corticosteroids is defined as ≥10 mg prednisone equivalent per day for ≥14 days.
• •Receipt of a live vaccine within 28 days or an inactivated or subprotein vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination with the exception of the inactivated influenza vaccine and COVID 19 vaccines either licensed or under EUA which can be given at any time, however all effort will be made to avoid giving influenza and COVID-19 vaccines within the above windows.
• •Asplenia.
• •Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination.
• •Anticipated receipt of any investigational agent in the 28 days before or after vaccination.
• •Subject has definite plans to travel to a ZIKV endemic or dengue endemic area during the study.
• •Previous hypersensitivity to any study product component.
• •Refusal to allow storage of specimens for future research.
• •Subject is a JHU student currently enrolled in a coursework, an internship, or clinical hours where the supervisor or instructor of record is employed by the Center.
• •Subject is faculty or staff currently employed by the Center.
• •History or serologic evidence of previous ZIKV, dengue virus infection, yellow fever virus, St. Louis encephalitis virus, or West Nile virus.
• •Previous receipt of a flavivirus vaccine (licensed or experimental).
• •Female assigned at birth only: Currently pregnant, as determined by positive B- HCG test, or breast-feeding.
• •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on history, physical examination, and/or laboratory studies.
• •Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.
• •History of a severe allergic reaction or anaphylaxis.
• •Any known immunodeficiency syndrome.
• •HIV infection, by screening and confirmatory assays (performed within 14 days of ZIKV challenge).
• •Hepatitis C virus (HCV) infection, by screening and confirmatory assays.
• •Hepatitis B virus (HBV) infection, by Hepatitis B surface antigen (HBsAg) screening.
• •Current use of anticoagulant medications (this does not include anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
• •Use of corticosteroids (excluding topical, inhaled, or nasal) or immunosuppressive drugs within 28 days prior to or following challenge. An immunosuppressive dose of corticosteroids is defined as ≥ 10 mg of a prednisone equivalent per day for ≥14 days.
• •Receipt of a live vaccine within 28 days or an inactivated or subprotein vaccine within the 14 days prior to inoculation or anticipated receipt of any vaccine during the 28 days following inoculation with the exception of the inactivated influenza vaccine and COVID-19 vaccines either licensed or under EUA which can be given at any time, however all effort will be made to avoid giving influenza and COVID-19 vaccines within the above windows.
• •Asplenia.
• •Receipt of blood products within the past 6 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following challenge.
• •Anticipated receipt of any other investigational agent in the 28 days before or after challenge.
• •Definite plans to travel to a dengue-endemic area during the remainder of the study.