Yellow FeverPhase 1SAFYRNCT06998004
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
A Phase 1 study testing AVX70120 low dose level, AVX70120 middle dose level and AVX70120 high dose level in people with Yellow Fever and Rabies, run by AstriVax Therapeutics at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever, Rabies
- What is being tested?
- AVX70120 low dose level, AVX70120 middle dose level and AVX70120 high dose level
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesBelgium
- Study dates
- 16 Jun 2024to 26 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Body Mass Index <18.0 or >32.0 kg/m2
- 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
Show all 21Show fewer
- 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
- Note: other protocol-defined inclusion / exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Centre for the Evaluation of Vaccination (CEV)
Antwerp
University Hospital Ghent - Centrum voor Vaccinologie (CEVAC)
Ghent
About this study
Official title: 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
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.
- Conditions
- Yellow Fever, Rabies
- Being tested
- AVX70120 low dose level, AVX70120 middle dose level, AVX70120 high dose level, AVX70481 low dose level, AVX70481 middle dose level
- Medical subject headings
- Yellow Fever, Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVX70120 low dose levelBiological
Low dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70120 middle dose levelBiological
Middle dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70120 high dose levelBiological
High dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever
AVX70481 low dose levelBiological
Low dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
AVX70481 middle dose levelBiological
Middle dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
AVX70481 high dose levelBiological
High dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AVX70120 low dose level | Experimental | Participants in this arm receive AVX70120 low dose level at Day 1 Receives: Biological: AVX70120 low dose level |
| AVX70120 middle dose level | Experimental | Participants in this arm receive AVX70120 middle dose level at Day 1 Receives: Biological: AVX70120 middle dose level |
| AVX70120 high dose level | Experimental | Participants in this arm receive AVX70120 high dose level at Day 1 Receives: Biological: AVX70120 high dose level |
| AVX70481 low dose level | Experimental | Participants in this arm receive AVX70481 low dose level at Day 1 Receives: Biological: AVX70481 low dose level |
| AVX70481 middle dose level | Experimental | Participants in this arm receive AVX70481 middle dose level at Day 1 Receives: Biological: AVX70481 middle dose level |
| AVX70481 high dose level | Experimental | Participants in this arm receive AVX70481 high dose level at Day 1 Receives: Biological: AVX70481 high dose level |
| Placebo | Placebo comparator | Participants in this arm receive Placebo at Day 1 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited adverse events
Measured: During a 14-day follow-up period after vaccination
Occurrence of unsolicited adverse events
Measured: From Day 1 up to 1 month after vaccination
Occurrence of hematological and biochemical laboratory abnormalities
Measured: From Day 1 up to 6 months after vaccination
Occurrence of adverse events of special interest
Measured: From Day 1 up to 1 year after vaccination
Occurrence of serious adverse events
Measured: From Day 1 up to 1 year after vaccination
Secondary outcomes (1)
Humoral immune response following administration of the investigational vaccines
Measured: From Day 1 up to 1 year after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start16 Jun 2024
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yellow FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstriVax Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998004
- Sponsor's protocol ID
- AVX1248-101
- Other IDs
- 2024-511194-29-00
- Acronym
- SAFYR
- Status last verified
- Apr 2026
- First submitted
- 22 May 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06998004
- Acronym / sponsor ID
- SAFYR / AVX1248-101
- Conditions
- Yellow Fever, Rabies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- AstriVax TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| AVX70120 low dose level | Experimental | Biological: AVX70120 low dose levelParticipants in this arm receive AVX70120 low dose level at Day 1 |
| AVX70120 middle dose level | Experimental | Biological: AVX70120 middle dose levelParticipants in this arm receive AVX70120 middle dose level at Day 1 |
| AVX70120 high dose level | Experimental | Biological: AVX70120 high dose levelParticipants in this arm receive AVX70120 high dose level at Day 1 |
| AVX70481 low dose level | Experimental | Biological: AVX70481 low dose levelParticipants in this arm receive AVX70481 low dose level at Day 1 |
| AVX70481 middle dose level | Experimental | Biological: AVX70481 middle dose levelParticipants in this arm receive AVX70481 middle dose level at Day 1 |
| AVX70481 high dose level | Experimental | Biological: AVX70481 high dose levelParticipants in this arm receive AVX70481 high dose level at Day 1 |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm receive Placebo at Day 1 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- Body Mass Index <18.0 or >32.0 kg/m2
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVX70120 low dose levelLow dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever | Biological | AVX70120 low dose level |
| AVX70120 middle dose levelMiddle dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever | Biological | AVX70120 middle dose level |
| AVX70120 high dose levelHigh dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever | Biological | AVX70120 high dose level |
| AVX70481 low dose levelLow dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies | Biological | AVX70481 low dose level |
| AVX70481 middle dose levelMiddle dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies | Biological | AVX70481 middle dose level |
| AVX70481 high dose levelHigh dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies | Biological | AVX70481 high dose level |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Occurrence of solicited adverse events
Time frame: During a 14-day follow-up period after vaccination
Occurrence of unsolicited adverse events
Time frame: From Day 1 up to 1 month after vaccination
Occurrence of hematological and biochemical laboratory abnormalities
Time frame: From Day 1 up to 6 months after vaccination
Occurrence of adverse events of special interest
Time frame: From Day 1 up to 1 year after vaccination
Occurrence of serious adverse events
Time frame: From Day 1 up to 1 year after vaccination
1 secondary outcome
Humoral immune response following administration of the investigational vaccines
Time frame: From Day 1 up to 1 year after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVX70120 low dose level, AVX70120 middle dose level and AVX70120 high dose level in people with Yellow Fever and Rabies, run by AstriVax Therapeutics at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited adverse events (time frame: During a 14-day follow-up period after vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.