New rabies vaccine shows promise in large trial
NCT ID NCT04127786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tested a new rabies vaccine (VRVg-2) in 1708 healthy children and adults in Thailand. The goal was to see if it works as well as two existing rabies vaccines when given before exposure to the virus. Participants received a series of shots, and some got a booster dose later. The study is complete, and results will show if the new vaccine is a safe and effective option.
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 safe and effective alternative rabies vaccine for pre-exposure prevention in both children and adults.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. The new vaccine must prove it is as good as existing ones, and rare side effects may still emerge.
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
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1,708 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Apr 2025
- 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
-
1 year and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Aged ≥1 year on the day of inclusion * Cohort 1 - pediatrics (\>1 to 17 years old) and adult (≥18 years old) * Cohort 2 - all adults (≥18 years old) * Informed consent form has been signed and dated by the participant and /or and parent(s) or legally acceptable representative (LAR) and by an independent witness (if required by local regulations), as necessary; and assent form has been signed and dated by the participant, as required * Participant (adult ≥18 years) or participant and parent/LAR (1 year to \<18 years) are able to attend all scheduled visits and to comply with all study procedures. Exclusion Criteria: * Participant is 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 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile. * Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 5 for pediatric participants and adult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort 2. * Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine. * Bite by, or exposure to a potentially rabid animal in the previous 6 months with or without post-exposure prophylaxis. * 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 study. * Known systemic hypersensitivity to any of the study/control vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. * Self-reported thrombocytopenia, contraindicating intramuscular vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion. * Chronic illness(1) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has 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. 1. Chronic illness may include, but is not limited to, neurological, cardiopulmonary, gastrointestinal, renal, genitourinary, metabolic, hematologic, auto-immune, or psychiatric disorders or infection
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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
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Investigational Site Number : 7640001
Bangkok, 10330, Thailand
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Investigational Site Number : 7640002
Khon Kaen, 40002, Thailand
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Investigational Site Number : 7640003
Bangkok, 10700, Thailand
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Investigational Site Number : 7640004
Bangkok, 10400, Thailand
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