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

NCT06998004 | Completed Phase 1

• 2 other identifiers: AVX1248-1012024-511194-29-00
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Yellow Fever; Rabies

Outcome Measures

Primary Outcomes (5)

• Occurrence of solicited adverse events

  During a 14-day follow-up period after vaccination

• Occurrence of unsolicited adverse events

  From Day 1 up to 1 month after vaccination

• Occurrence of hematological and biochemical laboratory abnormalities

  From Day 1 up to 6 months after vaccination

• Occurrence of adverse events of special interest

  From Day 1 up to 1 year after vaccination

• Occurrence of serious adverse events

  From Day 1 up to 1 year after vaccination

Secondary Outcomes (1)

• Humoral immune response following administration of the investigational vaccines

  From Day 1 up to 1 year after vaccination

Study Arms (7)

AVX70120 low dose level

EXPERIMENTAL

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

Biological: AVX70120 low dose level

AVX70120 middle dose level

EXPERIMENTAL

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

Biological: AVX70120 middle dose level

AVX70120 high dose level

EXPERIMENTAL

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

Biological: AVX70120 high dose level

AVX70481 low dose level

EXPERIMENTAL

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

Biological: AVX70481 low dose level

AVX70481 middle dose level

EXPERIMENTAL

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

Biological: AVX70481 middle dose level

AVX70481 high dose level

EXPERIMENTAL

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

Biological: AVX70481 high dose level

Placebo

PLACEBO COMPARATOR

Participants in this arm receive Placebo at Day 1

Other: Placebo

Interventions

AVX70120 low dose level BIOLOGICAL

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

AVX70120 low dose level

AVX70120 middle dose level BIOLOGICAL

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

AVX70120 middle dose level

AVX70120 high dose level BIOLOGICAL

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

AVX70120 high dose level

AVX70481 low dose level BIOLOGICAL

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

AVX70481 low dose level

AVX70481 middle dose level BIOLOGICAL

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

AVX70481 middle dose level

AVX70481 high dose level BIOLOGICAL

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

AVX70481 high dose level

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AstriVax Therapeutics: lead

Study Sites (2)

Centre for the Evaluation of Vaccination (CEV)

Antwerp, Belgium

Location

University Hospital Ghent - Centrum voor Vaccinologie (CEVAC)

Ghent, Belgium

Location

MeSH Terms

Conditions

Yellow Fever; Rabies

Interventions

Floors and Floorcoverings

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Rhabdoviridae Infections; Mononegavirales Infections

Intervention Hierarchy (Ancestors)

Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 16, 2024
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

BE (2)