Phase 3 N=640 Randomized Quadruple-blind Prevention

Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults

Rabies (Healthy Volunteers)

Bottom Line

View on ClinicalTrials.gov: NCT03965962 ↗

Enrolled (actual)

640

Serious AEs

1.7%

Results posted

Mar 2022

Primary outcome: Primary: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis — 99.6; 100; 98.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: VRVg-2 (Biological); Purified Inactivated Rabies Vaccine (Biological); Human Diploid Cell Vaccine (HDCV) (Biological); Rabies immune globulin (human) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sanofi Pasteur, a Sanofi Company
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis	99.6; 100; 98.7	—
SECONDARY Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL	0; 0; 0; 0; 92.5; 88.0	—
SECONDARY Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])	0; 0; 0; 0; 99.5; 100	—
SECONDARY Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus	0.100; 0.100; 0.100; 0.101; 2.40; 1.86	—
SECONDARY Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	24.0; 18.6; 18.3; 53.7; 64.8; 50.3	—
SECONDARY Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization	0.4; 0; 0; 1.4; 99.6; 100	—
SECONDARY Number of Participants With Immediate Unsolicited Adverse Events (AEs)	3; 0; 0; 1; 3; 0	—
SECONDARY Number of Participants With Solicited Injection Site Reactions	142; 37; 49; 44; 71; 19	—
SECONDARY Number of Participants With Solicited Systemic Reactions	4; 2; 4; 1; 0; 0	—
SECONDARY Number of Participants With Unsolicited Adverse Events	145; 46; 39; 42; 47; 22	—
SECONDARY Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	4; 4; 0; 3; 0; 2	—

Summary

Primary Objective: To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection. Secondary Objective: * To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection. * To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer >= 0.5 IU/mL at Day 28 was at least 95 percent (%). * To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).

Eligibility Criteria

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 ( =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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Data sourced from ClinicalTrials.gov (NCT03965962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.