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Promising new rabies vaccine passes phase 3 test

NCT ID NCT03965962

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tested a new rabies vaccine (VRVg-2) in 640 healthy adults in France. Participants received the vaccine along with rabies immune globulin, mimicking a real post-exposure scenario. The study found that VRVg-2 produced protective antibody levels as effectively as two existing rabies vaccines. The results suggest VRVg-2 could be a safe and effective option for preventing rabies after exposure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Purified Vero Rabies Vaccine - Serum Free (VRVg-2)
What this could lead to
If successful, this could provide a new, safe, and effective rabies vaccine option for people exposed to the virus.
What could go wrong
This trial was completed in healthy adults in France, so results may not apply to everyone. Rabies is rare in developed countries, and the vaccine's performance in real-world exposure settings may differ.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

640 people

The number who actually took part.

Started

Jul 2019

Finished

Jul 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * Men or women aged \>=18 years on the day of inclusion (\>= 18 years means from the day of the 18th birthday onwards, with no upper age limit). * Able to attend all scheduled visits and to comply with all trial procedures. * Body Mass Index (BMI): 18.5 kilograms per square meter (kg/m\^2) less than or equal to (\<=) BMI \<=30 kg/m\^2. Exclusion criteria: * Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. * Participation at the time of study enrollment or, planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 7. * Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccines or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * At high risk for rabies exposure during the trial (veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies was enzootic). * Known systemic hypersensitivity to any of the vaccine or HRIG components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Self-reported thrombocytopenia, contraindicating IM vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. * Current alcohol or substance abuse that, in the opinion of the investigator, might interfere with the trial conduct of completion. * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \>=38.0 degree Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Personal history of Guillain-Barré syndrome. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Investigational Site Number 2500001

    Rennes, 35000, France

  • Investigational Site Number 2500002

    Gières, 38610, France

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