APPLICATION FOR ANTISERA PRODUCTION
(type all responses)
Submit an electronic version to CompMed@research.usf.edu for veterinary pre-review prior to
submission to the University of South Florida, Institutional Animal Care & Use Committee,
MDC 35, phone 974-7106, fax 974-7091, email IACUC@research.usf.edu
PHS #A4100-01; USDA #58-R-0015; AAALAC #000434
IACUC#: S_________________
1. TITLE OF PROJECT
(Note: The title of this IACUC application must match the title of the grant that supports this research. If the described activity involving animals
is supported by multiple grants with different titles, or a grant is awarded later, during the 3-year approval period of this protocol, that supports
this research, inform the IACUC by completing and submitting a Request to Amend an Animal Use Protocol form.)
2. PERSONNEL
Principal Investigator (including degrees)
Position
Email Address
Primary Animal Handler
Phone
Department
Campus Address
Phone
3. QUALIFICATIONS
Name & Degree
Role
Years Experience/Rabbits
Cert#
(Note: Indicate role of involved personnel as either Principal (PI), or Secondary (SI) Investigators, or technicians/assistants (T). Indicate each
individual's years of experience with rabbits. Certification of orientation, training, and experience regarding the regulatory, occupational health
and safety, and care and use aspects of antisera production is required prior to IACUC review of this protocol, and is available from the IACUC
c/o the Division of Comparative Medicine, 974-9796. Certification numbers for each involved individual must be listed.)
4. FUNDING SOURCE
Agency:
Grant #:
(Indicate funding agency, grant #, and account #, if known.)
5. CERTIFICATION
A search for alternatives and alternative methods, including a search of at least two relevant databases (e.g., PubMed, SCIRUS)
indicated below, covering the indicated years (at least the last 10 yrs.), and using the indicated search term(s), demonstrates
that suitable alternatives to these procedures, and to aspects of these procedures which may cause pain or discomfort to
animals, or to this animal use are not available or applicable. The methods described will be used and continuously refined so
as to reduce animal discomfort and use. Conduct will be in accordance with the PHS policy, AWA, Guide, AAALAC guidelines,
DEA regulations, and IACUC Principles & Procedures. This project was designed with the consultation of a veterinarian. The
described animal use does not duplicate previous or existing studies. This description is complete and accurate. Implementing
changes to this description requires prior written IACUC approval. Current biomedical supplies will be used. Complete animal
procedural/surgical/testing records will be maintained. Personnel are certified as adequately trained and experienced, and have
complied with IACUC occupational health & safety procedures. Comparative Medicine will be notified whenever data from any
pre-clinical study involving animals is submitted to the Food & Drug Administration.
Identify ≥ 2 Databases:
Years:
Search
Terms:
(e.g., PubMed, SCIRUS)
__________________________________________________________________________________________________________________
Signature of Principal Investigator
CMDC #044.8
Effective 7/12
Date
1
6. EXPERIMENTAL PROCEDURES
Antiserum production using NZW rabbits by the Division of Comparative Medicine is the only method for which
animal use is requested. IACUC Principle & Procedure XVII will be adhered to without major exception. All
administrations, observations, phlebotomies, and treatments will be made and recorded by staff in the Division of
Comparative Medicine. Upon IACUC approval of this application, the PI will provide the immunizing antigen to the
Facility Manager, 974-9806, who will in turn coordinate and supervise the service.
A. Within the space below, briefly describe the antigen(s) of interest (e.g., IL-1 receptor), and its preparation (e.g.,
soluble, insoluble or particulate protein, or peptides conjugated to carrier proteins, or carbohydrates, etc.)
B. Indicate the number of rabbits requested. (Note: Only 2-4 rabbits/antigen are considered by the IACUC).
C. Methods for producing polyvalent antiserum, as described in IACUC Principles & Procedures XVII, will be
adhered to without exception:
Yes:
. Proceed to item #4.
No:
. Describe below the necessary minor deviations.
D. The applicant has reviewed IACUC Principles & Procedures XVII, and acknowledges that numerous adjuvant
systems and antisera production methods exist. Adjuvants known to produce less intense inflammatory
responses should be strongly considered as alternatives to Complete Freund’s Adjuvant (CFA). These
include TiterMax®, Ribi Adjuvant System (RAS®), Montanides®, Syntex Adjuvant Formulation (SAF®), aluminum
compounds (e.g., alum), and subcutaneously-implanted chambers. In many situations these alternatives are
capable of eliciting sufficient cellular and humoral antibody responses with fewer side effects than those commonly
seen with CFA. The following adjuvant system has been selected so that production of useful antisera is achieved
with the lowest possibility of causing animal discomfort:
TiterMax® Adjuvant System
Ribi Adjuvant System ®
E. If Complete Freund's Adjuvant is required for this research, Section 5, “Certification,” must clearly indicate that
the Principal Investigator has conducted a literature search for alternatives to painful /potentially painful procedures,
i.e., the use of CFA. To meet the requirements of the Public Health Service policies, the literature search should be
structured to ensure that the requirements have been addressed. “Search Terms” should include the terms
“anesthesia, exsanguination, polyclonal antibodies, adjuvant, pain, abscess, alternative adjuvants, RIBI®,
TiterMax®, MPL®, SAF® and early endpoint.” The information text box for Item E (below) of this Section should
provide information and justification for the use of complete Freund’s adjuvant.
Information and scientific justification for the use of Complete Freund’s Adjuvants:
(Note: Log entries describing all substance administrations, complications which develop as a consequence of substance administration to
nonrodent mammals, their treatment, the resolution of complications, and phlebotomies must be kept by staff of the Division of Comparative
Medicine.)
STOP here. This application is complete.
CMDC #044.8
Effective 6/12
2