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AzTrials

Rabies (Healthy Volunteers)Phase 3NCT04594551

Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland

A Phase 3 study testing Purified vero rabies vaccine - serum free, Purified inactivated rabies vaccine and Human rabies immunoglobulins in people with Rabies (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 3 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Rabies (Healthy Volunteers)
What is being tested?
Purified vero rabies vaccine - serum free, Purified inactivated rabies vaccine and Human rabies immunoglobulins
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
3 sitesThailand
Study dates
11 Oct 2020to 23 Jun 2021
Phase
Phase 3
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years on the day of inclusion
  • Able to attend all scheduled visits and to comply with all study procedures
  • Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2s

Who cannot join

  • Subject 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 and 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 7 (D90)
  • 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 without post-exposure prophylaxis
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
Show all 19Show fewer
  • 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
  • Known systemic hypersensitivity to any of the study/control vaccine components or to human rabies immunoglobulin (HRIG), 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 (IM) vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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 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 subject 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
  • Receipt of chloroquine or hydroxychloroquine up to 2 months prior to the study or through to study until Visit 7
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

  • Investigational site number 7640002

    Bangkok, 10330

  • Investigational site number 7640001

    Bangkok, 10400

  • Investigational site number 7640003

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) Using the Zagreb Regimen as Simulated Rabies Post-exposure Prophylaxis in Healthy Adults in Thailand

Primary Objective:

To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.

Secondary Objective:

Immunogenicity To describe the immune response induced by VRVg-2 and Verorab vaccines at D90 when co-administered with HRIG at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.

Safety To describe the safety profile of VRVg-2 and Verorab vaccines when co administered with HRIG at D0, after each vaccination.

Read the detailed description

The duration of each subject's participation in the study will be approximately 7 months (21 day-vaccination period followed by 6 months safety follow-up period).

Being tested
Purified vero rabies vaccine - serum free, Purified inactivated rabies vaccine, Human rabies immunoglobulins
Keywords
Rabies
Medical subject headings
Rabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Purified vero rabies vaccine - serum freeBiological

    Also called VRVg-2

    Pharmaceutical form:freeze-dried - Route of administration: intramuscular

  • Purified inactivated rabies vaccineBiological

    Also called Verorab

    Pharmaceutical form:freeze-dried - Route of administration: intramuscular

  • Human rabies immunoglobulinsBiological

    Also called HRIG

    Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular

Study groups in NCT04594551
Study groupRoleWhat they receive
Group 1: VRVg-2 + HRIGExperimentalVRVg-2 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 + HRIG at D0
Receives: Biological: Purified vero rabies vaccine - serum free; Biological: Human rabies immunoglobulins
Group 2: Verorab + HRIGActive comparatorVerorab 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 + HRIG at D0
Receives: Biological: Purified inactivated rabies vaccine; Biological: Human rabies immunoglobulins

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL

    RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)

    Measured: Day 14 (post-vaccination)

  2. Percentage of participants achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL

    RVNA titers will be measured by RFFIT

    Measured: Day 35 (post-vaccination)

  3. Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification

    RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL

    Measured: Day 14 (post-vaccination)

  4. Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification

    RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL

    Measured: Day 35 (post-vaccination)

  5. Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)

    RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 - RVNA ratios Day14/Day0 will be calculated

    Measured: Day 14 (post-vaccination

  6. Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)

    RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 35 - RVNA ratios Day35/Day0 will be calculated

    Measured: Day 35 (post-vaccination)

Secondary outcomes (8)

  1. Number of participants reporting immediate adverse events (AEs)

    Unsolicited (spontaneously reported) systematic AEs

    Measured: Within 30 minutes post-vaccination

  2. Percentage of participants reporting solicited injection site and systemic reactions

    Solicited injection site reactions:

    • pain, erythema, and swelling in adults (aged ≥ 18 years)

    Solicited systemic reactions:

    • fever, headache, malaise and myalgia in adults (aged ≥ 18 years)

    Measured: Within 7 days post-vaccination

  3. Number of participants reporting unsolicited injection site AEs

    Unsolicited injection site AEs

    Measured: Within 28 days post-vaccination

  4. Number of participants reporting unsolicited systemic AEs

    Unsolicited systemic AEs

    Measured: Between each vaccination and up to 28 days after the last vaccination

  5. Number of participants reporting serious adverse events (SAEs)

    SAEs, including adverse event of special interest (AESIs)

    Measured: Up to 6 months after last vaccination

  6. Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL

    RVNA titers will be measured by RFFIT

    Measured: Day 90 (post-vaccination)

  7. Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification

    RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL

    Measured: Day 90 (post-vaccination)

  8. Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)

    RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 - RVNA ratios Day90/Day0 will be calculated

    Measured: Day 90 (post-vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start11 Oct 2020
  3. Primary completion23 Jun 2021
  4. Study completion23 Jun 2021

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04594551
Sponsor's protocol ID
VRV00014
Other IDs
U1111-1238-1726
Status last verified
Sep 2025
First submitted
12 Oct 2020
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Purified vero rabies vaccine - serum free, Purified inactivated rabies vaccine and Human rabies immunoglobulins in people with Rabies (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 3 sites in Thailand.

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 3 inclusion and 19 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL (time frame: Day 14 (post-vaccination)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04594551.

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 19 Sep 2025.

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