ClinicalTrials.gg
CompletedNCT06998004SAFYRUpdated Apr 22, 2026

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 interventional study of AVX70120 low dose level and AVX70120 middle dose level in Yellow Fever and Rabies, sponsored by AstriVax Therapeutics. Completed at 2 sites in Belgium. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by AstriVax Therapeutics · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jun 2024, registered May 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Yellow Fever
  • Rabies

Browse trials for

03

In context

Yellow Fever

52 studies on the registry are indexed under Yellow Fever; 10 are open to participants now.

This study's enrollment of 112 is close to the median of 112 across 43 interventional studies indexed under Yellow Fever.

Browse Yellow Fever studies →

Lead sponsor

AstriVax Therapeutics is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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

Exclusion Criteria:

  • \<18.0 or >32.0 kg/m2
  • Use of any 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 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 disease
  • Personal or family history of thymic pathology
  • History of any neurological disorders or seizures
  • History of any reaction or likely to be exacerbated by any component of the investigational vaccines
  • 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 who is not utilising a highly effective 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.

Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    AVX70120 low dose level

    Participants in this arm receive AVX70120 low dose level at Day 1

    Biological: AVX70120 low dose level

  • Experimental
    AVX70120 middle dose level

    Participants in this arm receive AVX70120 middle dose level at Day 1

    Biological: AVX70120 middle dose level

  • Experimental
    AVX70120 high dose level

    Participants in this arm receive AVX70120 high dose level at Day 1

    Biological: AVX70120 high dose level

  • Experimental
    AVX70481 low dose level

    Participants in this arm receive AVX70481 low dose level at Day 1

    Biological: AVX70481 low dose level

  • Experimental
    AVX70481 middle dose level

    Participants in this arm receive AVX70481 middle dose level at Day 1

    Biological: AVX70481 middle dose level

  • Experimental
    AVX70481 high dose level

    Participants in this arm receive AVX70481 high dose level at Day 1

    Biological: AVX70481 high dose level

  • Placebo comparator
    Placebo

    Participants in this arm receive Placebo at Day 1

    Other: Placebo

Interventions

  • BiologicalAVX70120 low dose level

    Low dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever

  • BiologicalAVX70120 middle dose level

    Middle dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever

  • BiologicalAVX70120 high dose level

    High dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever

  • BiologicalAVX70481 low dose level

    Low dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies

  • BiologicalAVX70481 middle dose level

    Middle dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies

  • BiologicalAVX70481 high dose level

    High dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Occurrence of solicited adverse events

    Time frame: During a 14-day follow-up period after vaccination

  2. Occurrence of unsolicited adverse events

    Time frame: From Day 1 up to 1 month after vaccination

  3. Occurrence of hematological and biochemical laboratory abnormalities

    Time frame: From Day 1 up to 6 months after vaccination

  4. Occurrence of adverse events of special interest

    Time frame: From Day 1 up to 1 year after vaccination

  5. Occurrence of serious adverse events

    Time frame: From Day 1 up to 1 year after vaccination

Secondary outcomes

  1. Humoral immune response following administration of the investigational vaccines

    Time frame: From Day 1 up to 1 year after vaccination

07

Study locations

2 sites
  • Centre for the Evaluation of Vaccination (CEV)
    Antwerp, Belgium
  • University Hospital Ghent - Centrum voor Vaccinologie (CEVAC)
    Ghent, Belgium
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2024 to primary completion in Jan 2026, 19 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2025
First posted
May 31, 2025
StartActual
Jun 16, 2024
Primary completionActual
Jan 26, 2026
CompletionActual
Jan 26, 2026
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06998004
Lead sponsor
AstriVax Therapeutics
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Jun 16, 2024
Primary completion
Jan 26, 2026
Completion
Jan 26, 2026
Last update
Apr 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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