Immunogenicity and Safety of a Purified Vero Rabies Vaccine

Sanofi

Status and phase: Completed; Phase 2

Conditions: Rabies Virus

Treatments: Biological: Human Rabies Immunoglobulins (HRIG); Biological: Imovax Rabies; Biological: VRVg 1; Biological: VRVg 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03145766

VRV11

U1111-1174-4976 (Other Identifier)

Details and patient eligibility

About

This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.

Full description

This study assessed different formulations of the modified formulation of VRVg (VRVg 2- formulations 1 [low], 2 [medium] and 3 [high]) tested in parallel to the initial VRVg formulation (VRVg-1) and Imovax Rabies. Immune responses were assessed at Day 14, Day 28, Day 42, and at Month 7. Safety events were also reported.

Enrollment: 320 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:

1. Aged 18 to less than 65 years on the day of inclusion.
2. Informed consent form had been signed and dated.
3. Able to attend all scheduled visits and to complied with all trial procedures.
4. Body Mass Index (BMI): 18.5 kilograms per meter square (Kg/m^2) less than or equal to (<=) BMI <= 30 Kg/m^2.

Exclusion criteria

An individual fulfilling any of the following criteria was to be excluded from trial enrollment:

1. Participant was 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.
2. 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.
3. Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 6.
4. Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine.
5. Receipt of immune globulins, blood or blood-derived products in the past 3 months.
6. 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).
7. At high risk for rabies infection during the trial (e.g., veterinarians and staff, animal handlers, rabies researchers, or any others whose activities may bring them into frequent contact with rabies virus or animals who had the rabies virus).
8. Known systemic hypersensitivity to any of the vaccine or human rabies immunoglobulins (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.
9. Self-reported thrombocytopenia, contraindicating IM vaccination.
10. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
11. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
12. Current alcohol abuse or drug addiction.
13. Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion (e.g., cardiac disorders, renal disorders, auto immune disorders, diabetes, psychiatric disorders or chronic infection).
14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to [>=] 100.4 Fahrenheit >=38.0 Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
15. 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 (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
16. History of Guillain-Barré syndrome.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 5 patient groups

Group 1: VRVg-2 Formulation 1

Experimental group

Description:

VRVg-2 formulation 1, intramuscular (IM) injection on Days 0, 3, 7, 14 and 28. Concomitant administration of human rabies immunoglobulins (HRIG) on Day 0.

Treatment:

Biological: Human Rabies Immunoglobulins (HRIG)

Biological: VRVg 2

Biological: VRVg 2

Biological: VRVg 2

Group 2: VRVg-2 Formulation 2

Experimental group

Description:

VRVg-2 formulation 2, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.

Treatment:

Biological: Human Rabies Immunoglobulins (HRIG)

Biological: VRVg 2

Biological: VRVg 2

Biological: VRVg 2

Group 3: VRVg-2 Formulation 3

Experimental group

Description:

VRVg-2 formulation 3, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.

Treatment:

Biological: Human Rabies Immunoglobulins (HRIG)

Biological: VRVg 2

Biological: VRVg 2

Biological: VRVg 2

Group 4: VRVg-1

Experimental group

Description:

VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.

Treatment:

Biological: Human Rabies Immunoglobulins (HRIG)

Biological: VRVg 1

Group 5: Imovax Rabies

Active Comparator group

Description:

Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0.

Treatment:

Biological: Imovax Rabies

Biological: Human Rabies Immunoglobulins (HRIG)