Environmental Health & Safety

Botulism (Clostridium Botulinum)

General Information

Botulism is a rare but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium Botulinum. Clostridium Botulinum is the name of a group of bacteria that is frequently found in soil; these rod-shaped organisms grow best in low oxygen conditions. There are seven types of botulism toxin designated A through G. TSRI's Institutional Biosafety Committee has classified Botulinum as a category A pathogen; as such, immunization is required for individuals who plan to work with known cultures and purified Botulinum toxins.

Pentavalent (ABCDE) Botulinum Toxoid

Licensure

Botulinum Toxoid is NOT a U.S. Food and Drug Administration (FDA) licensed/approved product and is distributed as an Investigational New Drug in accordance with the requirements of the FDA.

Sponsor

The pentavalent (A, B, C, D, E) Botulinum toxoid is manufactured by the Michigan Biologic Products Institute and is distributed by the Centers for Disease Control.

Composition

Pentavalent (ABCDE) Botulinum toxoid Aluminum Phosphate Adsorbed is a combination of aluminumphosphate-adsorbed toxoid derived from formalin-inactivated, purified type ABCD and E Botulinum toxins.

Indications

The Botulinum toxoid should be administered only to healthy men and women between the ages of 18 and 65 years working in high-risk research laboratories that are actively working or expect to be working with known Botulinum cultures and/or purified Botulinum toxins. The effects of the toxoid during pregnancy or on individuals outside the 18 to 65 years of age population have not been studied.

Reactions

Since 1970, over 16,000 injections of the toxoid have been administered to recipients who were subsequently observed for adverse reactions. The rate of moderate and severe local reactions was 5.6% for the initial series of shots and 12.3% for booster shots. In addition, there was a low (4.5%) incidence of systemic reactions for both the initial series and the booster shots. The systemic reaction was generally mild consisting of pain and soreness, fever, tiredness, headache, rashes, and muscle pain. Systemic reactions were often concurrent with local reactions. Moderate local reactions include erythema, edema, and induration. All such reactions reach a peak in 24 hours, then gradually subside and should resolve completely within 48 to 72 hours.

Procedure and Dosage*

1. Upon receiving your instruction sheet, patient information sheet, and consent form from Environmental Health and Safety (4-8240), contact Sharp Rees-Stealy Medical Center, (858) 616-8400. Request an appointment with Dr. Stephen Munday for the administration of the Botulinum Toxoid. At least 48 hours prior to your scheduled appointment, be sure to thoroughly review the patient information sheet and sign the consent form. Dr. Munday's office is located at 2020 Genesee Ave. San Diego, CA 92123; his phone number is (858) 616-8400. [see attached map here]
2. Each 0.5-ml injection administered deep subcutaneously.
3. The administration and follow-up regime is as follows:
   T=0 (initial injection)
   T=0+2 weeks(second injection)
   T=0+12 weeks(third injection)
   T=0+24 weeks (fourth injection)
   
   Individuals may begin to work with Clostridium Botulinum cultures and/or Botulinum toxins following the third injection.
4. T=0+12 months (first booster)
5. T=0+24 months, 36 months, 48 months, etc.(annual boosters)

Efficacy:

Preliminary primate studies for Botulinum A indicate that the vaccine is effective against inhalation exposure. After completion of the initial vaccination series and the first booster, more than 90 percent of recipients develop protective antitoxin levels.

* Only individuals who have been specifically identified on an approved Microbiologic Hazard Registration Document specifying the active use of known Botulinum cultures or purified Botulinum toxins will be authorized to receive the Botulinum Toxoid.