Evaluating the Safety of and Immune Response to a Human Parainfluenza Virus Type 3 Ebola Virus Va… (NCT02564575) | Clinical Trial Compass
CompletedPhase 1
Evaluating the Safety of and Immune Response to a Human Parainfluenza Virus Type 3 Ebola Virus Vaccine (HPIV3-EbovZ GP) in Healthy Adults
United States30 participantsStarted 2015-08
Plain-language summary
The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Adult males and non-pregnant females between 18 years and 50 years of age inclusive. Children will not be recruited or enrolled in this study for safety considerations and because of the need for isolation.
* General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
* Low pre-existing serum antibody titers to HPIV3 (HAI titer less than or equal to 1:128).
* Agree to storage of blood specimens for future research.
* Available for the duration of the trial.
* Willingness to participate in the study as evidenced by signing the informed consent document.
* Female subjects of childbearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, subcutaneous and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse; surgical sterilization). All female subjects will be considered being of childbearing potential except those who have undergone documented hysterectomy or bilateral oophorectomy, and those in whom menopause occurred at least 1 year prior to the study, confirmed by testing.
* Willingness to refrain from blood donation during the course of the study.
* Willingness to refrain from receiving other vaccines or investigational products during the first 4 months of…
What they're measuring
1
Frequency of vaccine-related reactogenicity events
Timeframe: Measured through Day 56
2
Number of vaccinees infected with HPIV3-EbovZ GP vaccine virus when given at 10^6.0 or 10^7.0 PFU
Timeframe: Measured through Day 360
3
The titer of vaccine virus recovered from nasal wash specimens obtained from each recipient
Timeframe: Measured through Day 360
4
Number of days vaccine virus was shed, measured by plaque titration and rRT-PCR
Timeframe: Measured through Day 360
Trial details
NCT IDNCT02564575
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)