FIGURE 1. Would You Guess This Goat Has Had CL For Years?
Since in some cases concepts presented in later sections of this website build upon concepts presented in earlier sections, the material on this website is most effective when all sections are read from start to finish in the order presented, as opposed to reading individual sections out of sequence and out of context.
Section 1.0: Introduction
Section 2.0: Goals of this Website
Section 3.0: Intended Audience
Section 4.0: Woefully Necessary Legal Disclaimers
Section 5.0: Treatment of CL
Section 5.1: Use of Strain-Specific Autogenous CL Vaccine to Limit New CL Abscess Occurrences
Section 5.1.1: Necessary Medical Definitions
Section 5.1.2: Capturing the Bacteria Needed For Isolate and Vaccine Development
Section 5.1.3: Use of Your Autogenous Vaccine
Section 5.2: Applicable USDA Regulations
Section 5.2.1: One-Time, One-Year Isolate Extension
Section 5.2.2: Permanent Isolate Extension
Section 6.0: Miscellaneous
Section 6.1: Is CL contagious between species? Can a person become infected from a CL-infected animal?
Section 6.2: What is the persistence of the CL-causing bacteria in the farm environment?
Section 6.3: Can stress negatively affect my CL-infected goat?
Section 7.0: Points of Contact
Section 8.0: Related Websites
Section 9.0: Special Thanks
Section 10.0: Permitted Use of Copyrighted Material
Section 11.0: MAKE A DONATION
It is my sincere hope that the information on this website will:
My feeling is that the information on this website would be of interest to anyone who is currently dealing with CL (caprine or non-caprine) in a farm or research environment, or has the potential to do so in the future.
Owners of CL-infected pet goats, operators of farm animal rescues, and farm veterinarians would probably be most directly able to apply the information on this website as it is currently presented with minimal adaptation.
Some adaptation of the information on this website may be needed for application to a commercial environment. Adaptation to a commercial environment is not specifically addressed on this website. However, the points of contact provided in Section 7.0, Points of Contact could potentially be of valuable assistance to commercial enterprises for this purpose.
The goal of the treatment described in this section is to prevent new CL abscesses from forming in an infected goat, thereby limiting the long-term negative health effects of CL on the infected animal, as well as exposure of uninfected animals and the farm to the CL-causing bacteria, Corynebacterium pseudotuberculosis, which lives in the pus within CL abscesses.
It is my understanding from conversations I have had with the farm animal rescue Farm Sanctuary, which uses a treatment method similar to that described below in their CL-infected goat and sheep herd, that they have observed some newly rescued farm animals that were suffering severe negative health effects from CL obtain some benefit and improvement from receiving the treatment. However, for the most part, the treatment is most effectively used to prevent future abscesses from forming, as opposed to treating an existing abscess or health damage that has already occurred. In addition to the treatment regimen described on this website, a farm veterinarian should be consulted to obtain potential additional recommendations for conventional treatment with regard to past and present abscesses and related detrimental health effects.
The vast majority of future CL abscess formations in a CL-infected goat can be prevented by periodically inoculating the infected animal with a custom-made CL vaccine developed from the specific strain of Corynebacterium pseudotuberculosis bacteria with which the goat is infected.
It is seemingly illogical and counterintuitive to use a vaccine to treat disease in an infected individual. Ordinarily, vaccines are used to prevent disease in an uninfected individual (the custom CL vaccine can and should, of course, be used for this more typical purpose as well). Perhaps that is why this CL vaccine treatment approach is little known, and where known, is often regarded with skepticism by veterinarians.
This section, Section 5.1, will discuss how such a custom CL vaccine is developed and used for the treatment of CL, and then later, in Section 5.2, Applicable USDA Regulations, the USDA regulations that relate to these types of vaccines will be discussed in order to ensure the custom CL vaccine is available on a long-term, consistent, and uninterrupted basis to CL-infected animals that require treatment, as well as uninfected animals that require protection from infection.
These concepts need not be understood in their entirety from the provided definitions here alone. Rather, the definitions
are provided here to serve as an introduction to the concepts only . The terms will be used in
context in further discussion below, where their meaning should become clearer.
There are many varieties, or strains, of Corynebacterium pseudotuberculosis bacteria. There are Corynebacterium pseudotuberculosis bacteria that infect goats. There are Corynebacterium pseudotuberculosis bacteria that infect sheep. There are Corynebacterium pseudotuberculosis bacteria that infect horses. And so on. For a particular species of animal, there are even multiple varieties, or strains, of Corynebacterium pseudotuberculosis bacteria that infect that species. There are over 20 strains of Corynebacterium pseudotuberculosis bacteria that infect goats. The first goal in establishing a successful vaccine-based CL treatment program is to capture a sample of the specific strain of Corynebacterium pseudotuberculosis bacteria with which the goats to be treated are infected. This is commonly referred to as harvesting the bacteria.
The Corynebacterium pseudotuberculosis bacteria are found in the pus of an active CL abscess. Therefore, an active external CL abscess is needed in order to start a vaccine-based treatment program. When one of the CL-infected animals has an active external abscess, contact a farm veterinarian to either lance and extract the pus from the active abscess or surgically remove it as a unit. Once a pus sample has been obtained, the farm veterinarian should send the sample to a custom vaccine manufacturer, where the pus sample will be tested for the presence of Corynebacterium pseudotuberculosis bacteria. If Corynebacterium pseudotuberculosis bacteria are detected, the lab will separate (isolate) the Corynebacterium pseudotuberculosis bacteria from the pus and develop it into an isolate suitable for vaccine production. It may take more than one attempt to successfully capture Corynebacterium pseudotuberculosis bacteria. Once the vaccine laboratory has the Corynebacterium pseudotuberculosis bacteria in isolate form, an order can be placed by the farm veterinarian with the vaccine manufacturer for the first batch of CL vaccine to be custom made for the infected farm. Because the CL vaccine for the farm's goats is manufactured from bacteria from the farm's goats, the vaccine is called autogenous vaccine.
For the purpose of treating an animal already infected with CL, it is critical that CL vaccine is used that is manufactured from an isolate of the specific strain of Corynebacterium pseudotuberculosis bacteria with which the animal to be treated is infected.
The best way to guarantee you treat your CL-infected animals with the most effective CL vaccine possible (and maximize protection of your uninfected animals from infection) is to capture a pus sample from one of the CL-infected animals on your farm and manufacture your CL vaccine from a bacterial isolate derived from that pus sample. Using over-the-counter CL vaccine (whenever one becomes commercially available specifically for goats) or autogenous CL vaccine developed for a friend or neighbor's herd (unless your animals have had direct or indirect physical contact with your friend or neighbor's CL-infected animals) will probably not give you good control of CL on your farm unless by sheer dumb luck the vaccine happens to have been manufactured from an isolate of the same strain of the bacteria that is on your farm.
Note 1:
If you have multiple strains of Corynebacterium pseudotuberculosis bacteria on your farm, to get good CL control you will ultimately need to obtain a pus sample containing each strain, so that an isolate for each strain can be developed at the vaccine lab for inclusion of each strain in your autogenous CL vaccine. If you have new animals frequently arriving at your farm (or if one of your animals came from a farm where new animals were frequently arriving), there is a good possibility that you could have multiple strains of Corynebacterium pseudotuberculosis bacteria on your farm. Based on the excellent response my CL-infected goat Picasso has had to treatment with my farm's autogenous CL vaccine, it is my belief that he is infected with a single strain of goat CL, and that I have a single bacterial strain on my farm. Farm Sanctuary has extensive experience in the use of autogenous CL vaccine in a farm environment where there are multiple strains of Corynebacterium pseudotuberculosis present. If you suspect you may have multiple strains on your farm (for example, if you aren't getting good treatment results from an autogenous CL vaccine manufactured from a single isolate from your farm), you may consider seeking additional advice from Farm Sanctuary regarding the handling of multiple strains. Contact information for Farm Sanctuary is provided in Section 7.0, Points of Contact.
Note 2:
It is possible over time for bacteria to naturally evolve from its current strain into a new strain, necessitating reharvesting of bacteria and development of a new isolate for the newly evolved strain. After over two years of being treated with my farm's autogenous CL vaccine, my CL-infected goat Picasso remains free of any detrimental CL health effects. Therefore, to date I am continuing to use my original Corynebacterium pseudotuberculosis isolate for vaccine production. I am, however, always vigilant for any sign of a decrease in the effectiveness of my current autogenous CL vaccine's ability to control Picasso's CL, which could indicate that the current strain of Corynebacterium pseudotuberculosis on my farm may have evolved into a new strain. If at some point in the future Picasso again begins to develop abscesses, I will consider reharvesting and updating my vaccine at that time.
Note 3:
I use MVP Laboratories in Omaha, Nebraska for my autogenous CL vaccine production. Isolate development, a batch of autogenous CL vaccine, and 2-day shipping using MVP Laboratories will cost approximately $850. Shipping costs will vary with the size of your order, but at MVP the cost of a batch of vaccine is the same no matter how many vials are ordered or what size they are. MVP Laboratories, upon request, can produce vials of vaccine as small as 20 ml. This is of importance to me, since I have a small number of goats on my farm. The larger minimum vaccine vial sizes which other labs often produce are more appropriate for larger herds. Long-term storage and re-use of a vaccine vial once its sterile seal has been pierced by a hypodermic needle are not recommended medical practices, so in addition to cost, also consider the availability of the most appropriate vaccine batch size and vial size for your farm when selecting an autogenous vaccine laboratory. U.S. residents should check with your state's Department of Agriculture to see if there are any regulations specific to your state that may influence your selection of an autogenous vaccine lab (Non-U.S. residents should check for the existence of applicable regional statutes in your country of residence). For example, it is my understanding from conversations I have had with PHL Associates, an autogenous vaccine manufacturer in Davis, California, that for isolates originating in California, California state law permits use of an isolate for three years, one year longer than the two-year limit permitted under Federal regulations (discussed in Section 5.2, Applicable USDA Regulations). Therefore, California residents may wish to consider using an autogenous vaccine laboratory within the state of California in order to take advantage of this. All autogenous vaccine laboratories in the U.S. are licensed by the USDA.
Note 4:
It is worthwhile to have your autogenous vaccine lab run an Antibiotic Susceptibility Test (sometimes also called an Antibiotic Sensitivity Test) using your isolate to determine the antibiotics to which your particular Corynebacterium pseudotuberculosis strain is most responsive. It is an inexpensive test, and this is critical information for your farm veterinarian to have on hand in the event there is a need to treat a CL-related infection with antibiotics at some point in an animal's life. Antibiotics in general are not an effective means to treat CL, but if the occasion arises when antibiotics must be used, your farm veterinarian will know the most effective antibiotics to use against the specific CL strain on your farm.
The life-long autogenous CL vaccine control and treatment program used on my farm is provided below. Note that the dosage, method, and frequency of vaccination of CL-infected animals on your farm may vary from that described below based on the recommendations of the specific laboratory developing your autogenous CL vaccine, as well as those of your farm veterinarian.
The only side effect of the use of the autogenous CL vaccine that I have ever observed is localized swelling at the vaccination site. In my goat Picasso, the swelling is fairly significant, and lasts as long as 7-12 months. In my goat Esmeralda, the swelling is much less, and lasts about 21 days. Since the swelling at the vaccination sites in some goats can last for as much as a year, it is a good idea to make a record of the location of each vaccination site, so that local vaccination-related reactions can be differentiated from an actual CL abscess occurrence (since both look like lumps).
Uninfected animals should also be routinely protected from infection using the same autogenous CL vaccine. Vaccine laboratory and farm veterinarian recommendations for routine vaccination of uninfected animals living on a farm where CL is known to be present should be followed. For simplicity, my farm veterinarian revaccinates my infected and uninfected animals on the same vaccination schedule (described above).
As you can see, it's fairly trivial to implement an autogenous CL vaccine treatment program, and while it is not a cure, the use of autogenous vaccine helps reduce the frequency, size, and growth rate of CL abscesses that occur dramatically, improving the quality of life for both goats and goat owners alike, and minimizing exposure of the farm to CL-causing Corynebacterium pseudotuberculosis bacteria.
The next section, Section 5.2, Applicable USDA Regulations, discusses in detail the USDA regulations that relate to autogenous vaccines. In order to ensure an uninterrupted supply of your farm's vaccine for your CL-infected and uninfected animals, anyone considering starting an autogenous CL vaccine treatment program should become thoroughly familiar with these USDA regulations.
U.S. Residents: In addition to USDA regulations discussed in this section, some state regulations in the home state of your vaccine lab may also be relevant to your isolate and your autogenous vaccine; ask your vaccine lab regarding state-specific isolate and vaccine regulations that may affect you. Also, since your farm veterinarian is licensed by your state, there may possibly be some state regulations in your home state that may be relevant to your isolate and your vaccine; ask your farm veterinarian regarding state-specific isolate and vaccine regulations that may affect you. Also contact your state's Department of Agriculture to determine if there are other state-specific regulations that may apply.
In order to most effectively use the autogenous CL vaccine treatment approached described above in Section 5.1, Use of Strain-Specific Autogenous CL Vaccine to Limit New CL Abscess Occurrences, you need to have a basic working knowledge of the USDA regulations that apply to autogenous vaccines. More specifically, you need to be aware that the isolate from which your autogenous vaccine is produced has an expiration date which you must be proactively involved in extending if you wish to have an uninterrupted supply of your vaccine continuously available for the treatment of your CL-infected animals and the protection of your uninfected animals.
The USDA regulation that defines the law with regard to isolates and autogenous vaccines is 9 CFR Part 113.113, Autogenous Biologics, where CFR stands for Code of Federal Regulations. A link to the complete text of 9 CFR Part 113.113 has been included in Section 8.0, Related Websites. As a USDA-licensed entity, your vaccine lab is very familiar with this Federal regulation, but it is worthwhile for you to have a fundamental knowledge as well.
The only parts of 9 CFR Part 113.113 that will be discussed on this website are the parts that relate to ensuring your isolate expiration date gets extended so that the isolate will be available for autogenous CL vaccine production. For any questions you may have related to anything else in 9 CFR Part 113.113, contact your autogenous vaccine lab. If after consulting with your vaccine lab you still need or would like additional information, you can contact the USDA Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics (CVB), which is the body within the USDA that is responsible for inspection, compliance, licensing, and policy related to 9 CFR Part 113.113 and autogenous biologics. Contact information for the USDA APHIS CVB is provided in Section 7.0, Points of Contact, and a link to its website is provided in Section 8.0, Related Websites.
The isolate expiration date differs from (is typically shorter than) the expiration date of the vials of autogenous CL vaccine manufactured from the isolate. 9 CFR Part 113.113 requires the vials of vaccine produced from an isolate to have an expiration date not exceeding 18 months. 9 CFR Part 113.113 requires an isolate to expire 15 months from the date of isolation or 12 months from the date of the isolate's first use in vaccine production, whichever comes first. Since the purpose of developing the isolate in the first place was to produce vaccine from it, more than likely it is the 12-month isolate expiration date that will apply to your isolate. If you do not proactively extend the isolate expiration date, the isolate will expire before your first batch of vaccine does, and you will not be able to produce a second batch of vaccine from the isolate when the first batch of vaccine expires. Ask your vaccine lab what the exact date is when your isolate will expire, as well as when the lab recommends submission of paperwork to the USDA to extend the date. Keep in mind that vaccine lab personnel are very busy and deal with many isolates over the course of a year; do not count on your vaccine lab to remind you when it's time to extend your isolate.
As opposed to extending an isolate's expiration date, some people consider it preferable to allow an isolate to expire and to reharvest bacteria for a new isolate as described in Section 5.1.2, Capturing the Bacteria Needed For Isolate and Vaccine Development. Reharvesting has the advantages of relative ease, low cost, and obtaining a sample of the "latest" version of the Corynebacterium pseudotuberculosis bacteria that may have naturally evolved on your farm for use in your next batch of autogenous CL vaccine. Reharvesting has the disadvantages of allowing nature and USDA regulations to dictate what isolates are available for use in your vaccine, and risking re-exposure of your farm to CL, since an active external CL abscess is needed in order to reharvest. Reharvesting is also painful for the goat from which new pus is to be acquired, since it requires lancing of the abscess so that pus can be collected.
In order to give you an understanding of all your options related to isolate expiration date extension, the specific process involved in extending your isolate will be discussed in detail in Section 5.2.1, One-Time, One-Year Isolate Extension, and Section 5.2.2, Permanent Isolate Extension. With this information, you can then decide what options you do and do not want to pursue for your farm. In addition, for those of you who suspect you may have multiple strains of CL on your farm, I would also suggest you contact Farm Sanctuary, which uses autogenous CL vaccine to treat its CL-infected goat and sheep herd, and has multiple known strains of CL on its New York and California farms. Farm Sanctuary may be able to give you additional advice regarding management of isolates and autogenous vaccine for multiple strains of CL. Contact information for Farm Sanctuary is provided in Section 7.0, Points of Contact, and its website is provided in Section 8.0, Related Websites.
Extending the use of the isolate to 24 months from the date of isolation is an easy, straightforward process. Your vaccine lab will send a form entitled Request For Authorization To Produce Additional Serials (or something equivalent) to your farm veterinarian. Your farm veterinarian fills out the form, essentially providing justification to the USDA as to why continued availability of the isolate for vaccine production is needed. Justification derives from the fact that you are using the autogenous CL vaccine made from your isolate for long-term treatment of CL-infected animals, as opposed to a more traditional strictly preventative use of the vaccine in uninfected animals. The form is then returned by your farm veterinarian to your vaccine lab, which then formally submits the extension request to the USDA (specifically to the USDA APHIS Center For Veterinary Biologics Inspection and Compliance Unit [CVB-IC]).
In general the paperwork for this extension process should be started about two months before your isolate's effective expiration date, but check with your specific vaccine lab to see how much lead time before expiration of your isolate that they recommend to start this process. Keep in mind that vaccine lab personnel, your farm veterinarian, and USDA personnel are all busy people, so allow time for that fact. Given the straightforward nature of the paperwork and process for extending use of the isolate for up to 24 months from the date of isolation, with proper planning the extension can be accomplished with little difficulty.
Without question, obtaining a permanent extension is more challenging than the simple submission of a request form to the USDA, as was necessary to obtain the initial one-year extension of the use of your isolate as described in Section 5.2.1, One-Time, One-Year Isolate Extension. To obtain a permanent extension, 9 CFR Part 113.113 requires formal testing to be conducted. It is my hope that one day 9 CFR Part 113.113 will be modified to exclude from this testing autogenous CL vaccine users who have no intention of selling their vaccine, as it my opinion that the formal testing requirement deters most autogenous CL vaccine users from seeking isolate extension past 24 months, and is, therefore, counterproductive to the control of CL, since reharvesting bacteria for a new isolate requires an active external CL abscess, which risks re-exposure of both the farm and the animals on it to CL. Unfortunately, at this point in time, whether you are a pet goat owner, non-profit farm rescue, small family business, or large corporation you are required to conduct formal testing to extend use of your isolate past 24 months from the date of isolation. Fortunately, within the scope of current regulations, CVB-PEL has some flexibility in defining the nature and extent of formal testing that needs to be conducted.
My vaccine lab initially told me that to conduct the formal testing required to extend the use of my isolate past 24 months from the date of isolation
would cost tens of thousands of dollars. I was heartbroken. My beloved CL-infected goat, Picasso, had responded so well to the autogenous CL
vaccine treatment described in Section 5.1.3, Use of Your Autogenous Vaccine, and in every way was enjoying the same quality
of life that a goat that is not infected with CL enjoys. And now, because of a USDA regulation, Picasso was going to be robbed of what is,
in my opinion, the only available effective treatment for CL. It was in this state of complete desperation that in January 2009 I wrote to
the USDA APHIS CVB, explaining in my letter:
The truth is, at the time that I wrote to the USDA, I considered it an exercise in futility, an act of final desperation. I needed to know in my heart that I had tried everything in my power to preserve Picasso's good health and quality of life, so I didn't have to watch him suffer the ill effects of a disease that I had successfully controlled in his body for years. I held out little hope that the USDA would even hear my plea, much less help me. I couldn't have been more wrong. I cannot speak highly enough of the response I received from the CVB. CVB personnel facilitated a teleconference between the CVB, my vaccine lab, and myself. They helped to devise a scaled-down test regimen that would meet the letter of regulatory law, but which I could afford to conduct. In short, they found a cost-effective way for me to extend use of my isolate permanently, for Picasso to continue to get his life-preserving autogenous CL vaccine, and for my farm to not be needlessly re-exposed to CL.
Before you give up on seeking permanent extension of the use of your isolate because of what you have heard from your vaccine lab, your friends, or your other associates, write the CVB and give them an opportunity to work with you and your vaccine lab. They may or may not be able to find a solution for your specific situation that both you and your vaccine lab consider satisfactory, but it is my opinion that the personnel at the CVB are some of the finest individuals I have ever encountered, and that they will make every effort in their power to work with you to find an affordable way for you to conduct the formal testing required to renew your isolate permanently.
Even though it may appear contrary to formal test methodology your vaccine lab was required to use in the past under 9 CFR Part 113.113, your vaccine lab, as a USDA-licensed entity, will follow whatever guidelines the CVB sets forth for use in your formal test, so if you are interested in pursuing permanent extension of the use of your Corynebacterium pseudotuberculosis isolate, in my opinion, the CVB is the place to start (CVB-PEL specifically). USDA APHIS CVB points of contact are provided in Section 7.0, Points of Contact.
Dr. Brian Erdahl of USDA APHIS CVB-PEL informed me that I was the first individual (non-business) in USDA history to pursue, and be granted, a permanent isolate extension. If I can do it, you can do it.
Note: USDA regulations require autogenous vaccine laboratories to remove expired isolates from their licensed premises. This is accomplished by some vaccine labs by destroying the isolate. However, this need not be the case. If you wish to pursue a permanent isolate extension, and your isolate will expire prior to the completion of formal testing, you can request your vaccine lab to temporarily move your expiring isolate to off-site unlicensed storage. Autogenous vaccine labs routinely do this, and will ordinarily have such a storage facility already identified. After successful completion of formal testing and being granted a permanent isolate extension, your vaccine lab is then permitted to move your isolate back to its licensed premises, so that it available for future vaccine production.
This section discusses a variety of CL-related topics which my experience has shown me to be largely misrepresented within the goat community.
I have read in numerous places on the Internet that CL is contagious between animal species, even to people. This often directly results in a sense of complete fear and panic when CL first appears on a farm. I know it did for me. When I discovered Picasso had CL, and read on the Internet that it was contagious to other species, including people, I thought that Picasso, all the other animals on my farm, and I were all going to die from it.
Here's what I know:
So if CL were truly contagious between species, why haven't people with extensive experience with CL in a real farm environment seen examples of it?
I have read in numerous places on the Internet that Corynebacterium pseudotuberculosis, the CL-causing bacteria, can survive (persist) for years on a farm.
I read a goat-based Corynebacterium pseudotuberculosis persistence veterinary study using infected pus on common barnyard materials:
Table 1 in the article documents overall results from this persistence study and leads to the following conclusions for the temperature range and materials used in the study:
That said, I feel the above-referenced study falls short in two areas:
Based on this one study at least, it does not appear that claims of the bacteria persisting for years in the farm environment are valid, and that the greater likelihood is that the farm environment is being constantly re-exposed/re-infected by CL-infected animals on the farm, as opposed to the original bacteria to which the farm was exposed actually persisting for years. However, I would like to see additional information on this topic for the study areas that I cited above as lacking before I feel comfortable reaching any definitive conclusion.
The autogenous vaccine treatment described in Section 5.1, Use of Strain-Specific Autogenous CL Vaccine to Limit New CL Abscess Occurrences, uses the vaccine to stimulate the CL-infected animal's immune system against the CL bacteria with which its body is infected. Therefore, in my opinion, anything that has the potential to negatively affect the goat's immune system will also potentially negatively affect your control of its CL. Conversely, anything that has the potential to positively affect the goat's immune system will also potentially positively affect your control of its CL.
For example:
Websites related to the use of autogenous CL vaccines:
Other Shambhala Farm websites:
I would like to express my sincere thanks to the following individuals who have had a significant role in the continued good health of my CL-infected goat, Picasso:
All text and photographs on this website are copyrighted by the author, but may be freely reproduced for strictly non-profit purposes. Any intended for-profit use of the material on this website must be expressly approved in advance of use in writing by the author.
Please help as little or as much as you can. All contributions are appreciated.