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Trial record 1 of 1 for:    VRV00014
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Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594551
Recruitment Status : Completed
First Posted : October 20, 2020
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Rabies (Healthy Volunteers) Biological: Purified vero rabies vaccine - serum free Biological: Purified inactivated rabies vaccine Biological: Human rabies immunoglobulins Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : October 11, 2020
Actual Primary Completion Date : June 23, 2021
Actual Study Completion Date : June 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: VRVg-2 + HRIG

VRVg-2 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21

+ HRIG at D0

Biological: Purified vero rabies vaccine - serum free
Pharmaceutical form:freeze-dried - Route of administration: intramuscular
Other Name: VRVg-2

Biological: Human rabies immunoglobulins
Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular
Other Name: HRIG

Active Comparator: Group 2: Verorab + HRIG

Verorab 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21

+ HRIG at D0

Biological: Purified inactivated rabies vaccine
Pharmaceutical form:freeze-dried - Route of administration: intramuscular
Other Name: Verorab

Biological: Human rabies immunoglobulins
Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular
Other Name: HRIG




Primary Outcome Measures :
  1. 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) ]
    RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)

  2. Percentage of participants achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL [ Time Frame: Day 35 (post-vaccination) ]
    RVNA titers will be measured by RFFIT

  3. Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification [ Time Frame: Day 14 (post-vaccination) ]
    RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL

  4. Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification [ Time Frame: Day 35 (post-vaccination) ]
    RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL

  5. Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) [ Time Frame: Day 14 (post-vaccination ]
    RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 - RVNA ratios Day14/Day0 will be calculated

  6. Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) [ Time Frame: Day 35 (post-vaccination) ]
    RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 35 - RVNA ratios Day35/Day0 will be calculated


Secondary Outcome Measures :
  1. Number of participants reporting immediate adverse events (AEs) [ Time Frame: Within 30 minutes post-vaccination ]
    Unsolicited (spontaneously reported) systematic AEs

  2. Percentage of participants reporting solicited injection site and systemic reactions [ Time Frame: Within 7 days post-vaccination ]

    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)


  3. Number of participants reporting unsolicited injection site AEs [ Time Frame: Within 28 days post-vaccination ]
    Unsolicited injection site AEs

  4. Number of participants reporting unsolicited systemic AEs [ Time Frame: Between each vaccination and up to 28 days after the last vaccination ]
    Unsolicited systemic AEs

  5. Number of participants reporting serious adverse events (SAEs) [ Time Frame: Up to 6 months after last vaccination ]
    SAEs, including adverse event of special interest (AESIs)

  6. Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL [ Time Frame: Day 90 (post-vaccination) ]
    RVNA titers will be measured by RFFIT

  7. Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification [ Time Frame: Day 90 (post-vaccination) ]
    RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL

  8. Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) [ Time Frame: Day 90 (post-vaccination) ]
    RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 - RVNA ratios Day90/Day0 will be calculated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • 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

Exclusion criteria:

  • 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
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594551


Locations
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Thailand
Investigational site number 7640002
Bangkok, Thailand, 10330
Investigational site number 7640001
Bangkok, Thailand, 10400
Investigational site number 7640003
Bangkok, Thailand, 10700
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04594551    
Other Study ID Numbers: VRV00014
U1111-1238-1726 ( Other Identifier: UTN )
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sanofi:
Rabies
Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Infections
Vaccines
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs