A Phase I, Randomized, Double-blind, Multi-centre, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of AstriVax' Investigational Vaccine for the Prevention of Yellow Fever (AVX70120), and of AstriVax' Investigational Vaccine for the Prevention of Rabies (AVX70481), in Healthy Adults Aged 18 to 40 Years
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this first time in humans trial is to evaluate the safety, reactogenicity and immunogenicity of AVX70120 and of AVX70481 in healthy participants.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:
• Male or female between, and including, 18 and 40 years of age on the day of the Screening Visit
• Healthy individual, as established by the Investigator
• Able to read and understand the informed consent form, and written informed consent obtained from the participant
• Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol
Locations
Other Locations
Belgium
Centre for the Evaluation of Vaccination (CEV)
RECRUITING
Antwerp
University Hospital Ghent - Centrum voor Vaccinologie (CEVAC)
RECRUITING
Ghent
Time Frame
Start Date: 2024-06-16
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 144
Treatments
Experimental: AVX70120 low dose level
Participants in this arm receive AVX70120 low dose level at Day 1
Experimental: AVX70120 middle dose level
Participants in this arm receive AVX70120 middle dose level at Day 1
Experimental: AVX70120 high dose level
Participants in this arm receive AVX70120 high dose level at Day 1
Experimental: AVX70481 low dose level
Participants in this arm receive AVX70481 low dose level at Day 1
Experimental: AVX70481 middle dose level
Participants in this arm receive AVX70481 middle dose level at Day 1
Experimental: AVX70481 high dose level
Participants in this arm receive AVX70481 high dose level at Day 1
Placebo_comparator: Placebo
Participants in this arm receive Placebo at Day 1
Related Therapeutic Areas
Sponsors
Leads: AstriVax Therapeutics