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About
This First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
Full description
This First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
The study vaccine dose is planned to be staggered, starting with the low-dose group (0.45 mg), followed by the mid-dose group (0.9 mg), and finally the high-dose group (1.8 mg). In total 15 healthy volunteers at the ages of 18-60 will be enrolled.
Primary objective:
• The primary objective of this study is to assess the safety and reactogenicity of the investigational vaccine N-pVAX1 delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
The secondary objectives:
• To investigate the humoral immune response to the investigational vaccine administered as three doses, by measuring CCHF nucleocapsid antibody levels.
Exploratory objective:
• To investigate in more detail the humoral response and to analyze the cellular immune response to the investigational vaccine.
Trial participants will be followed-up for local and systemic adverse reactions throughout the study period. Blood samples to measure presence of antibody levels to the vaccine components and cellular immunity will be taken at Day 14 and 28 post first and second vaccine dose and at Day 14 and 3 months post last vaccine dose.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Men and women between the ages of 18 and 60 years (at the time of consent).
Healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments.
No clinically significant laboratory abnormalities as determined by the investigator at screening.
Note: one retest of lab tests is allowed within the screening window.
Negative HIV 1/2 antibody/antigen test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening.
Participant with a body mass index (BMI) 20-30.0 kg/m2.
Provide written informed consent before initiation of any study procedures.
A female participant is eligible for this study if she is one of the following:
Highly effective methods of contraception include one or more of the following:
A female participant is eligible if she is willing to abstain from donating oocyte and a male participant if he is willing to abstain from donating sperm from the screening visit up to 3 months after last vaccination.
A male participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 3 months after last vaccination except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception.
Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Central trial contact
Soo Aleman, MD, PhD
Data sourced from clinicaltrials.gov
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