A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for the Prevention of Yellow Fever, and of an Investigational Vaccine for the Prevention of Rabies, in Healthy Adults
NCT ID: NCT06998004
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
144 participants
INTERVENTIONAL
2024-06-16
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in Adults
NCT07002060
Trial of Yellow Fever Inactivated Vaccine
NCT00995865
Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
NCT04142086
Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
NCT01662440
Simultaneous Administration Study of Varicella Attenuated Live Vaccine and Trivalent Inactivated Influenza Vaccine (Split Virion)
NCT06987942
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AVX70120 low dose level
Participants in this arm receive AVX70120 low dose level at Day 1
AVX70120 low dose level
Low dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70120 middle dose level
Participants in this arm receive AVX70120 middle dose level at Day 1
AVX70120 middle dose level
Middle dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70120 high dose level
Participants in this arm receive AVX70120 high dose level at Day 1
AVX70120 high dose level
High dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70481 low dose level
Participants in this arm receive AVX70481 low dose level at Day 1
AVX70481 low dose level
Low dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
AVX70481 middle dose level
Participants in this arm receive AVX70481 middle dose level at Day 1
AVX70481 middle dose level
Middle dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
AVX70481 high dose level
Participants in this arm receive AVX70481 high dose level at Day 1
AVX70481 high dose level
High dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
Placebo
Participants in this arm receive Placebo at Day 1
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AVX70120 low dose level
Low dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70120 middle dose level
Middle dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70120 high dose level
High dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70481 low dose level
Low dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
AVX70481 middle dose level
Middle dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
AVX70481 high dose level
High dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Use of any investigational or non-registered product other than the study intervention within 1 month preceding study vaccination, or planned use during the study period
* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or non-registered product
* Administration / planned administration of any vaccine not foreseen by the study protocol within 1 month preceding study vaccination and up to Day 31
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months preceding study vaccination, or planned chronic administration at any time during the study period
* Planned administration of long-acting immune-modifying drugs at any time during the study period
* Administration of immunoglobulins and / or any blood or blood-derived products within 3 months preceding study vaccination, or planned administration during the study period
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, family history or physical examination
* History of or current autoimmune disease
* Personal or family history of thymic pathology
* History of any neurological disorders or seizures
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the investigational vaccines
* Malignancies or lymphoproliferative disorders within previous 5 years
* Moderate or severe acute disease in the opinion of the Investigator, and / or fever at the time of study intervention
* Alcohol, prescription drug, or substance (ab)use that, in the opinion of the Investigator, might interfere with the study conduct or completion
* Pregnant or lactating woman
* Woman of childbearing potential who is not utilising a highly effective birth control method for at least 1 month preceding study vaccination, or planning to discontinue highly effective birth control methods during the study period.
* Participants employed by the Sponsor, by the vendors working on behalf of the Sponsor, by the Investigator or the study site, or close relatives of research staff working on this study
* Medical condition or use of medication(s) that can increase the risk of bleeding or haematoma
* Any other condition or finding that the Investigator judges may interfere with study procedures or study results
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstriVax Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre for the Evaluation of Vaccination (CEV)
Antwerp, , Belgium
University Hospital Ghent - Centrum voor Vaccinologie (CEVAC)
Ghent, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-511194-29-00
Identifier Type: CTIS
Identifier Source: secondary_id
AVX1248-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.