Phase 2
N=320
Immunogenicity and Safety of a Purified Vero Rabies Vaccine
Rabies Virus
Bottom Line
View on ClinicalTrials.gov: NCT03145766 ↗Enrolled (actual)
320
Serious AEs
0.3%
Results posted
Jan 2021
Primary outcome: Primary: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 — 0.101; 0.100; 0.102; 0.101 international units per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VRVg 2 (Biological); VRVg 1 (Biological); Imovax Rabies (Biological); Human Rabies Immunoglobulins (HRIG) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0 |
0.101; 0.100; 0.102; 0.101; 0.100 | — |
| PRIMARY Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 14 |
1.28; 1.79; 2.52; 1.38; 1.56 | — |
| PRIMARY Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 28 |
3.22; 4.64; 6.81; 3.04; 4.86 | — |
| PRIMARY Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Day 42 |
8.14; 9.68; 15.6; 6.98; 8.99 | — |
| PRIMARY Rabies Virus Neutralizing Antibody Geometric Mean Titers Against Rabies Virus at Month 7 |
0.894; 0.971; 1.58; 0.939; 1.01 | — |
| PRIMARY Percentage of Participants With Rabies Virus Neutralizing Antibody Titer Greater Than or Equal to (>=) 0.2 IU/mL and >=0.5 IU/mL at Day 0 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 14 |
93.1; 96.0; 97.2; 97.1; 97.1; 75.0 | — |
| PRIMARY Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 28 |
98.5; 98.6; 100; 96.6; 100; 93.9 | — |
| PRIMARY Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Day 42 |
100; 98.6; 100; 96.7; 100; 100 | — |
| PRIMARY Percentage of Participants With RVNA Titers >=0.2 IU/mL and >=0.5 IU/mL at Month 7 |
93.4; 93.0; 100; 92.6; 87.1; 70.5 | — |
| PRIMARY Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody 7 Days Following Vaccination 3 (Day 14/Day 0) |
12.7; 17.9; 24.8; 13.7; 15.6 | — |
| PRIMARY Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 4 (Day 28/Day 0) |
31.9; 46.4; 67.0; 30.0; 48.6 | — |
| PRIMARY Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 14 Days Following Vaccination 5 (Day 42/Day 0) |
80.7; 96.8; 153; 69.0; 89.9 | — |
| PRIMARY Geometric Mean Titer Ratio of Rabies Virus Neutralizing Antibody 6 Months Following Last Vaccination (Month 7/Day 0) |
8.86; 9.71; 15.5; 9.27; 10.1 | — |
| PRIMARY Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 0 |
0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 14 |
79.2; 89.3; 93.0; 82.9; 85.3 | — |
| PRIMARY Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 28 |
92.8; 94.6; 98.6; 100; 93.9 | — |
| PRIMARY Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Day 42 |
97.1; 93.2; 94.1; 100; 93.9 | — |
| PRIMARY Percentage of Participants With Complete Virus Neutralization at Starting Dilution (1/5) of Rapid Fluorescent Focus Inhibition Test Assay at Month 7 |
95.1; 88.7; 100; 85.2; 93.5 | — |
| PRIMARY Number of Participants With Immediate Unsolicited Adverse Events |
0; 1; 0; 0; 2; 0 | — |
| PRIMARY Number of Participants With at Least One Solicited Injection Site Reactions |
29; 32; 38; 14; 24; 13 | — |
| PRIMARY Number of Participants With at Least One Solicited Systemic Reactions |
0; 1; 2; 0; 0; 0 | — |
| PRIMARY Number of Participants With at Least One Unsolicited Adverse Events |
11; 11; 20; 10; 18 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
0; 0; 1; 0; 0 | — |
Summary
This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.
Eligibility Criteria
Inclusion Criteria
An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- Aged 18 to less than 65 years on the day of inclusion.
- Informed consent form had been signed and dated.
- Able to attend all scheduled visits and to complied with all trial procedures.
- Body Mass Index (BMI): 18.5 kilograms per meter square (Kg/m^2) less 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.
- 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.
- History of Guillain-Barré syndrome.
Data sourced from ClinicalTrials.gov (NCT03145766). 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.