Guideline #12

Use of Freund's Complete Adjuvant (FCA)

1. Reference: Immunization Procedures and Adjuvant Products. ILAR Journal, Vol. 45 No. 5, 2005; pp. 271-274 & 282-285.

2. Purpose/Scope: The purpose of this policy is to provide guidance to principle investigators who may request to use Freund’s complete adjuvant (FCA) for antibody (Ab) production in laboratory animals.

3. General: The IACUC is responsible for ensuring that investigators consider alternatives to any procedures that cause more than momentary or slight pain or distress, provide a written narrative description of the methods and sources used to search for alternatives to such procedures, and justify why alternatives that are less painful/distressful cannot be used. Whereas FCA is an effective adjuvant for use with most all types of antigens (Ag) to stimulate immune responses (Ab production) in laboratory animals, the improper use of Freund’s Complete Adjuvant (FCA) may cause more than slight momentary and/or transient pain or distress depending on species and route of administration due to excessive inflammation and swelling, abscess formation, ulceration, and tissue necrosis. This guideline outlines the procedures and practices that must be strictly followed in order to minimize the potential for pain/distress and adverse side effects associated with the use of FCA in laboratory animals.

4. Freund’s Complete Adjuvant (FCA):

4.1. An AV Consult is required prior to IACUC review for all proposed use of FCA in laboratory animals.

4.2. The use of FCA for initial immunizations must be scientifically justified and approved by the IACUC. FCA should only be used for the first (priming) antigenic dose.
NOTE: A search for alternatives is required and the use of other commercially available adjuvants must be considered (e.g., Montanide, RIBI, Titermax, etc.).

4.3. The use of FCA for booster immunizations (any route) is prohibited except when scientifically justified and approved by the IACUC. Freund’s Incomplete Adjuvant (FIA) may be used for booster immunizations.

4.4. Injection sites shall be aseptically prepped (i.e., fur clipped/shaved and skin injection site aseptically disinfected with surgical scrub followed by alcohol).

4.5. FCA injections shall be administered SC (most common/preferred route). ID injections may be used in larger species. IM, IP, IV, or footpad injections of FCA are prohibited except when scientifically justified and approved by the IACUC.

4.6. FCA shall be injected at 1 site using the smallest volume possible (see table below). A maximum of up to 4 injection sites may be used if scientifically justified and approved by the IACUC. If multiple injection sites are approved the injection sites shall be adequately separated to avoid coalescence.

 

LAST REVIEWED AND ADOPTED BY THE IACUC: December 21, 2023