Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve… (NCT03611946) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
United States56 participantsStarted 2018-07-06
Plain-language summary
This is a phase 1 double-blind, placebo controlled trial designed to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Adult male or female between 18 and 50 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, which is approximately 26 weeks.
* Willingness to participate in the study as evidenced by signing the informed consent document.
* Females only: Female subjects of childbearing potential, with the exception noted below, should be willing to use effective contraception and have no plans to undergo IVF (in vitro fertilization) during participation in the trial. Reliable methods of contraception include hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, and intrauterine device. Women must have been on an effective method of birth control for at least 30 days prior to enrollment. All female subjects will be considered as having childbearing potential, except for women who exclusively have sex with women, those who have had a hysterectomy, tubal ligation, or tubal coil (at least 3 months prior to vaccination), or are considered to be post-menopausal, as documented by at least 1 year since last menstrual period with a follicle-stimulating hormone (FSH) level in the menopausal range or at least 24 consecutive months of amenorrhea. Transgender men who have internal female organs and have sex with men will be considered of childbearing potential and should be willing to use effective contraceptio…
What they're measuring
1
Number of Participants With Solicited Local and General Adverse Events (AEs)
Timeframe: Solicited AE's assessed every visit through Day 28
2
To Determine the Immunogenicity of a Single Dose of rZIKV/D4Δ30-713
Timeframe: Measured through Day 28
Trial details
NCT IDNCT03611946
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)