A Phase 1 Evaluation of the Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV003 or Previous Zika Infection Against Infection With ZIKV-SJRP Challenge Compared to DENV and ZIKV-naïve Historical Controls Against Infection With ZIKV-SJRP Challenge
Zika virus (ZIKV) is an illness people can get from mosquitoes. The infection is generally mild with symptoms that include a fever, rash, red eyes, and joint pain, though most of those infected have no symptoms. Preventing ZIKV is important because if a pregnant person is infected with ZIKV, it can cause birth defects in their unborn child. The goals of this study are to find out if people who have already been infected with one type of ZIKV can get infected with ZIKV a second time, and to test the ability of the TV003 dengue vaccine to prevent people from getting infected with the ZIKV-SJRP challenge virus.
⁃ Adults between 18 and 40 years of age, inclusive.
⁃ Good general health as determined by physical examination, laboratory screening, and review of medical history.
⁃ Available for the duration of the study, approximately 52 weeks.
⁃ Willingness to participate in the study as evidenced by signing the informed consent document.
⁃ Must be able to complete the informed consent process and comprehension assessment independently and without assistance.
⁃ Subjects assigned male at birth: Willingness to use barrier contraception during cervico-vaginal, anal, and oral intercourse from Study Day 0 through 90 days post ZIKV challenge (in accordance with CDC guidance).
⁃ Subjects assigned female at birth: Willingness to use barrier contraception during cervico-vaginal, anal, and oral intercourse from Study Day 0 through 56 days post ZIKV challenge (in accordance with CDC guidance).
⁃ Subjects of childbearing potential must be willing to use effective contraception through 56 days post-ZIKV challenge, in accordance with CDC guidance. Reliable methods of contraception include hormonal birth control\* (implantable, hormonal patch, hormonal vaginal ring, oral contraception, Depo-Provera injection, etc.), surgical sterilization (hysterectomy, tubal ligation, or tubal coil at least 3 months prior to inoculation with TV003/PlasmaLyte and/or ZIKV challenge), and intrauterine device. All subjects assigned female at birth will be considered having child-bearing potential except for those with post-menopausal status documented as at least 1 year since last menstrual period, those assigned female at birth who have sex with partners assigned female at birth (exclusively) and have no intention of conceiving a child during the study, and for the vaccination phase of the study only, participants who practice abstinence (≥ 6 months with no sexual contact). Subjects who are not considered to be of childbearing potential will not be required to use contraception other than barrier contraception for the purpose of reducing potential transmission.
‣ Volunteers on hormonal birth control must not be on medications or other agents that decrease the effectiveness of hormonal birth control.
⁃ Currently enrolled in the study.
⁃ Good general health as determined by physical examination and review of medical history.
⁃ Available for the duration of the study, which is approximately 26 weeks after challenge.
⁃ If the challenge portion of the study is expected to begin from March 16-October 30, subject is willing to reside in the inpatient unit for 6 days (or longer for safety if necessary) following receipt of ZIKV.
⁃ Willingness to participate in the study as evidenced by signing the informed consent document.
⁃ Female assigned at birth only: Female assigned at birth subjects of childbearing potential should be willing to use highly effective contraception for the duration of the trial. Reliable methods of contraception include hormonal birth control, surgical sterilization, and intrauterine device. All female assigned at birth subjects will be considered as having childbearing potential in this phase of the study, except for those who have had a hysterectomy, tubal ligation, or tubal coil (at least 3 months prior to vaccination), or who are considered to be post-menopausal, as documented by at least 1 year since last menstrual period.
∙ Additional Inclusion Criteria for Arm 2 Subjects with a Previous History of ZIKV Infection Only:
• History or serologic evidence of previous ZIKV or identified as an infectivity control.