Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expres… (NCT03462004) | Clinical Trial Compass
TerminatedPhase 1
Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
Stopped: Cancel Enrollment due to Covid-19 Pandemic, Not restarted
United States15 participantsStarted 2018-03-05
Plain-language summary
The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of two doses of the HPIV3/ΔHNF/EbovZ GP vaccine candidate when administered intranasally 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 and 50 years of age inclusive
* General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
* Agree to storage of blood specimens for future research
* Available for the duration of the trial
* Able to demonstrate understanding of key study concepts, study rationale, and study participation requirements by scoring greater than or equal to 70% on a written comprehension assessment in less than or equal to 3 attempts.
* Willingness to participate in the study as evidenced by signing the informed consent document
* Female subjects of childbearing potential must agree to have used effective birth control methods beginning at least one month prior to vaccination, and continuing with 'per label/fully effective use' for the chosen method for the duration of the study, from amongst these:
* pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous, and transcutaneous delivery;
* condoms with spermicide;
* diaphragm with spermicideÍľ
* intrauterine device;
* absolute abstinence from heterosexual intercourse as a matter of normal preferred lifestyle;
* or must be surgically sterile, or must be age 50 AND have had no menses at all for at least one full year.
* All females must provide samples for urine and serum pregnancy testing prior to enrollment (immediately prior to each vacc…
What they're measuring
1
Frequency of vaccine-related solicited adverse events
Timeframe: Measured through Day 35
2
Area under the curve of nasal virus shedding after each dose of vaccine
Timeframe: Measured through Day 35
3
Development of serum antibody to the EbovZ GP
Timeframe: Measured through Day 360
Trial details
NCT IDNCT03462004
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)