Studies of Rabies Immune Globulin (Human) 29 IMOGAM^® RABIES given with the first of five doses of Pasteur Mérieux Sérums et Vaccins S. A. HDCV ¹ confirmed that passive immunization with 20 IU/kg of Rabies Immune Globulin (Human) provides maximum circulating antibody with minimum interference of active immunization by HDCV.

A double-blind randomized trial 30 was conducted to compare the safety and antibody levels achieved following intramuscular injection of IMOGAM^® RABIES - HT (heat treated) and Rabies Immune Globulin (Human), IMOGAM ^® RABIES (non-heat treated). Each immune globulin was administered on day 0, either alone or in combination with the human diploid cell Rabies Vaccine (IMOVAX^® RABIES) using the standard post-exposure prophylactic schedule of day 0, 3, 7, 14, and 28.

Sixty-four healthy veterinary student volunteers were randomized into four parallel groups of 16 each to receive the following immune globulin and vaccine regimens.

The dosage corresponded to the post- exposure recommended dose of 20 IU/ kg of rabies immune globulin and was administered in three, equally divided IM injections of under 5 mL in either gluteus. Serum rabies antibody levels were assessed before treatment and on days 3, 7, 14, 28, 35, and 42 by the Rabies Fluorescent Focus Inhibition Test (RFFIT).

Serum antibody levels were similar in the IMOGAM ^® RABIES - HT and IMOGAM ^® RABIES groups. By day three, 60% of each group had detectable antibody titers of > 0.05 IU/mL. By day 14, the geometric mean titers (with 95% confidence interval) were 19 IU/mL (11-38) in the IMOGAM ^® R.B.E. - HT + vaccine group and 31 IU/mL (20-48) in the IMOGAM ^® R.B.E. + vaccine group. These differences were not statistically different.

Two subjects reported severe headaches, one in the IMOGAM ^® R.B.E. - HT + placebo group and one in the IMOGAM ^® Rabies + IMOVAX ^®Rabies group. One third of the volunteers had moderate systemic (headache and malaise) reactions. These were equally distributed among the 4 treatment groups with no significant differences between the groups.

Both IMOGAM ^® RABIES - HT and IMOGAM ^® R.B.E. were safe and without serious adverse events or allergic reactions. The safety profile did not differ between groups, although IMOGAM ^® RABIES - HT produced fewer and milder local reactions such as pain or tenderness at the injection site.

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