Imovax® Rabies Vaccine 2023
Imovax® Rabies is an inactivated vaccine from an attenuated rabies virus prepared from the WISTAR Rabies PM/WI 38 1503-3M strain. Sanofi Pasteur SA produces the virus from infected human diploid cells, MRC-5 strain, concentrated by ultrafiltration and inactivated by beta-propiolactone.
The finished, freeze-dried vaccine is provided for intramuscular administration in a single-dose vial containing no preservative. After reconstitution, immediately administer the full 1.0 mL amount of vaccine. The potency of one dose (1.0 mL) of the Imovax Rabies vaccine is equal to or greater than 2.5 international units of rabies antigen.
On May 6, 2022, the U.S. CDC published: Use of a Modified Preexposure Prophylaxis Vaccination Schedule to Prevent Human Rabies: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022. These CDC updates are as efficacious as previous recommendations and might facilitate improved adherence to vaccination recommendations.
Imovax Indication
Imovax Rabies is a vaccine indicated for preexposure and post-exposure prophylaxis against rabies. Imovax Rabies vaccine is approved for use in all age groups. Post-exposure efficacy of the Imovax Rabies vaccine was successfully proven during a clinical experience in Iran in which six 1.0 mL doses were given on days 0, 3, 7, 14, 30, and 90, in conjunction with antirabies serum. Forty-five persons severely bitten by rabid dogs and wolves received the Imovax Rabies vaccine within hours of and up to 14 days after the bites. All individuals were fully protected against rabies.
Imovax Dosage
Imovax Rabies is administered as an intramuscular injection containing no preservativesThehe Imovax Rabies vaccine should be administered to the deltoid musc for adults and older childrenleThehe anterolateral aspect of the thigh is also acceptable for infants and younger children, depending on age and body mass. One dose of reconstituted vaccine contains less than 100 mg of human albumin, less than 150 mcg of neomycin sulfate, and 20 mcg of phenol red indicator. Beta-propiolactone, a residual component of the manufacturing process, is present in less than 50 parts per million.
Imovax Availability
Call Sanofi Pasteur at 1-800-VACCINE if IMOVAX is unavailable from your wholesaler or distributor.
Imovax News
May 10, 2022 - British Columbia health warned about the consequences of bat encounters. According to the Interior Health Authority, between four and eight percent of bats that come into contact with people in B.C. are then found to be carriers of the rabies virus.
Imovax Clinical Trials
Clinical Trial NCT02956746: A Comparison of the Safety, PD, and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines (RabiesMab). This is a single-site, randomized, blinded comparison of the immunogenicity of Imovax (RVi) and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023, RVi+RIG, RVa+SYN023, and RVa+RIG. The initial dose of RVi and RVa will be co-administered with either RIG or SYN023). Rabies virus neutralizing activity (RVNA) and blood levels of SYN023 will be measured for the remainder of the trial while the rest of the five RVi and RVa doses are given. The study will last 112 days addition, s. SYN023 concentrations and anti-SYN023 antibodies will also be measured.
Clinical Trial NCT01930357: Phase 2 Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Preexposure Prophylaxis Regimen. To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of the proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i,.e. 14 days after the last vaccination. To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97% in the VRVg group.
