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From: Derek Moody on 5 Mar 2007 04:27
http://spayvac.org/index.html

SpayVac� is a contraceptive vaccine that has proven highly effective
in deer and can be used to control populations. Deer overabundance has
become extreme in many parts of the US, and as communities struggle
with this problem, many wish for an effective, non-lethal solution.
SpayVac�-for-Wildlife, Inc., (SFW) is a not-for-profit corporation
that has been formed to make this vaccine available.

About SpayVac�

History
In the early 1990s, researchers at Dalhousie University (Halifax, Nova
Scotia) undertook the challenge of developing a contraceptive vaccine
for potential use on seals. Knowing from the outset that seals would
not be accessible for more than a single inoculation, the Dalhousie
team set their minds to creating a single-dose, long-lasting vaccine.
They developed a unique means of delivering the PZP antigens to the
immune system in liposomes, which are submicroscopic, multi-layered
vesicles. This liposome technology is responsible for the
extraordinary efficacy of SpayVac�. The work that began at Dalhousie
is being continued by ImmunoVaccine Technologies, Inc. (IVT).

For more information about IVT's liposome technology, visit
www.immunovaccine.com and open the VacciMax� link.
Unparalleled Performance
Independent trials have shown that a single dose of SpayVac� can
contracept deer for at least 3 years. No treated deer became pregnant
over 3 years in trials on Fallow Deer by TerraMar Environmental
Research Ltd., or on White-tailed Deer by the USDA�s National Wildlife
Research Center conducted at Penn State University.

The long-lasting, single-dose efficacy contrasts sharply with the
results of other PZP vaccines, which require frequent boosting. When
other vaccines are used, previously treated animals have to be
relocated before each breeding season and given a booster dose,
usually with a dart. Repeated boosting exposes the animals to
increased stress and greatly increases the cost and technical
difficulty of implementing IC to control deer populations. SpayVac�
removes these impediments.

How SpayVac� Works

Biology
The porcine zona pellucida (PZP) antigens in contraceptive vaccines
such as SpayVac� cause a treated female mammal to produce antibodies
that adhere to the surface of her own eggs and prevent sperm from
binding, thus blocking fertilization.

Field Use
Because SpayVac� is long lasting, it can be administered whenever
fieldwork is most efficiently conducted and when animals can be
captured safely and easily. To avoid treating animals repeatedly,
which would expose them to stress and potential injury, animals can be
marked with ear tags, collars, tattoos, and/or microchip tags. In
hunting areas, these marks enable hunters to discriminate between
treated and untreated animals.


Controlling Wildlife Populations
Controlling overabundant populations of wildlife requires more than
just effective fertility control:
a large proportion of the population must be treated to result in a
decline. As a rule-of-thumb for deer populations, treating 80% of the
reproductive females is necessary. Research on deer populations at the
Fire Island National Seashore, New York(4), and the National Institute
of Standards and Technology campus, Maryland(5), have proven that
populations of deer can be controlled with IC. These and other studies
have also shown that PZP is safe for contracepted deer.

Although SpayVac� meets the requirement for a single-dose,
long-lasting vaccine, successful use also requires the ability to
treat a large enough proportion of the population to be able to
control the number of animals.

(4) Naugle, R.E., et al. 2002. Field testing of immunocontraception on
white-tailed deer (Odocoileus virginianus) on Fire Island National
Seashore, New York, USA. Reproduction Supplement 60:143-153.
(5) Rutberg, A.T., et al. in press. Effects of immunocontraception on
a
suburban population of white-tailed deer Odocoileus virginianus.
Biological Conservation.


Answers to Frequently Asked Questions About Wildlife Applications for
SpayVac�
How does SpayVac� work?
The antigens in SpayVac�, porcine (pig) zona pellucida (PZP) proteins,
cause a treated female mammal to produce antibodies that adhere to the
surface (zona pellucida) of her own ova (eggs) and prevent sperm from
binding, thus blocking fertilization.

What is SpayVac� composed of?
SpayVac� is made up of three components: the antigen (PZP extracted
and purified from pigs ovaries), liposomes (cholesterol and lecithin),
and an adjuvant, to stimulate the immune response. Except for the PZP
antigen, all other components have been previously approved in other
vaccines. However, PZP has been incorporated into research vaccines
for >20 years.

Does SpayVac� affect the well-being of treated animals?
Because SpayVac� results only in antibodies that block sperm binding,
the effects on treated animals are minimal. The largest changes relate
to the fact that most treated animals will not become pregnant, and in
some species (e.g., White-tailed Deer), repeated estrous cycles result
in repeated matings. The result may be an extended breeding period and
increased mating activity. Increased longevity of treated wild horses
has been also been reported. PZP vaccines have been used in wildlife
and zoo animals for about 20 years and are generally regarded as safe.

Is SpayVac� environmentally safe?
Unlike hormone contraceptives, which can find their way into the food
chain, PZP protein antigens and the resulting antibodies are harmless
to the environment. PZP antigens and antibodies are digested like any
other proteins by humans, predators, scavengers, and microbes.

How much experience is there with SpayVac�?
SpayVac� was developed in the early 1990s by scientists from Dalhousie
University in Halifax, Nova Scotia, Canada. It was first tested on
several species of seals, and much experimental work was conducted
using laboratory rabbits. In Grey Seals, SpayVac� has provided
contraception for at least 10 years. In 3-year studies of Fallow Deer
and White-tailed Deer, SpayVac� has been 100 % effective. Studies
involving Domestic Cats, Barbary Sheep, Horses, Grizzly Bears, and
Wolves are underway or have been concluded. Over the past 20 years,
conventional PZP vaccines have been tried successfully in many other
mammalian species. [For a complete account of the Fallow Deer study,
see Fraker et al. 2002. Long-lasting, single-dose immunocontraception
of feral fallow deer in British Columbia. Journal of Wildlife
Management 66(4):1141-1147.].

How often do treated individuals have to be inoculated to maintain
contraception?
In long-term experiments with Grey Seals, SpayVac� has been effective
for at least 10 years with only a single inoculation. SpayVac� has
been 100% effective for 3 years in both Fallow and White-tailed Deer.
Experiments with other species have not yet extended beyond 1 year. We
expect that SpayVac� will have multi-year effectiveness in many
species of mammal, but the exact duration probably will vary according
to species. Only testing for many years can accurately assess
effective duration.

Is there any particular time of year when SpayVac� should be
administered?
SpayVac� can be administered whenever fieldwork is most conveniently
conducted and when animals can be captured easily and safely. For
example, with deer, capture and treatment should not occur immediately
prior to fawning, when does and their unborn fawns might be especially
vulnerable to injury, nor in the few weeks following fawning, when
dependent fawns might become separated from their dams. At present,
our limited experience suggests that antibody titers should rise to
contraceptive levels within about 60 days post treatment. Thus, if it
is hoped that deer are to be effectively contracepted before a
particular rutting season, they should be inoculated at least 60 days
prior.

What is the difference between SpayVac� and conventional PZP vaccines?
Conventional vaccines use PZP proteins (antigens) and an adjuvant
(immune response stimulant). SpayVac� uses exactly the same antigens
and often the same adjuvant as do conventional vaccines. The critical
difference is that the PZP proteins in SpayVac� are encapsulated in
liposomes, which protect them while they are being carried to the
immune system. Liposomes have been used for many years and are
recognized as safe components of therapeutics.

In practical terms, the most important difference between SpayVac� and
the conventional PZP vaccine is performance. SpayVac� is the only
vaccine to achieve multi-year contraception with just one
administration. The conventional vaccine initially requires a primary
inoculation followed by 1 or 2 boosters within a few weeks, with
annual boosters afterwards. Although the conventional vaccine has been
used in trials on deer at a number of locations, the need to hold
animals for extended periods to administer initial boosters (or
relocate and �dart� free-ranging animals) and to administer annual
boosters makes the conventional vaccine generally impractical.

Because only a single administration is required, SpayVac� will be
much less expensive to use than conventional vaccines and will involve
much less stress for treated animals. The greatest expense in
implementing fertility control is incurred for catching and holding
animals. Each capture treatment involves stress and a risk of injury
to both animals and workers.

What is an adjuvant and which adjuvant is used in SpayVac�?
Adjuvants are materials that are incorporated into vaccines to enhance
the immune response. Trials of the conventional PZP vaccines have
routinely used Freund�s Complete Adjuvant (FCA), which is recognized
as the �gold standard� of adjuvants and is used widely in vaccine
research. FCA has also been used in trials of SpayVac�. Although FCA
is a very powerful adjuvant, some individual animals may respond
adversely, and vaccines containing FCA cannot obtain regulatory
approval. Fortunately, SpayVac� performs well with another adjuvant,
AdjuVac, which has regulatory approval. Although we may continue to
use FCA for research, other adjuvants, with regulatory approval, such
as AdjuVac, would be used in SpayVac� formulations intended for
routine use.
Are there limitations to using SpayVac� to manage wildlife fertility?
Yes. For the foreseeable future, it will be practical to treat only
small populations that are isolated and accessible. The present
state-of-the-art requires that all treated animals be captured and
marked before being treated, and this will be difficult to achieve in
many situations. By itself, contraception cannot quickly reduce the
size of a population of concern.

Must SpayVac�-treated animals be marked? How?
In most cases, Yes, with at least ear tags and often with marking
collars or radio collars, tattoos, and/or microchip tags, which are
methods that are routinely and safely used in wildlife research. In
field use, the primary reason for this is to avoid treating the same
individuals more than once, which would expose animals to potential
injury from darts or other capture methods. In areas where hunting
occurs, marking animals would allow hunters to discriminate between
treated and untreated animals. While SpayVac� is undergoing scientific
trials, positive identification of individual animals is also
necessary.

Can SpayVac� be safely administered to pregnant animals?
Yes. SpayVac�-elicited antibodies affect only unfertilized eggs. There
is no effect on pregnancies already in progress.

Does SpayVac� have any effect on the DNA of treated animals?
No. As with any other immune response, there is no effect on the genes
of treated animals.

Does SpayVac� works on males as well as on females?
No. SpayVac� will elicit antibody production in males, but because
males do not have ovaries, they do not possess eggs or zona pellucida
proteins. Thus SpayVac� has no useful effect on males.

How much does SpayVac� cost?
At present, SpayVac� is not in commercial production and a price has
not yet been set. However, the most expensive part of any wildlife
contraception program is securing the animals to be treated, and
because SpayVac� requires only a single administration, overall costs
will be much less than those involved with the conventional vaccine.

How can I obtain SpayVac� for use on deer or other wildlife in my
area?
The responsibility for wildlife management generally rests with state
or provincial wildlife agencies. Thus, an early step should be to
consult with the appropriate people within the responsible management
agency. If there is a desire to try SpayVac�, this may be possible
under the provisions for field trials contained in Food and Drug
Administration (FDA) rules in the USA, Health Canada rules in Canada,
or the rules of the appropriate agency elsewhere.

ImmunoVaccine Technologies Inc. (IVT), Halifax, Nova Scotia, Canada,
is commercializing SpayVac� for use on companion animals and wildlife.
TerraMar Environmental Research Ltd., Sidney, BC, Canada, is the
�strategic partner� with IVT for research and development of SpayVac�
for wildlife applications.

When will SpayVac� be commercially available?
In early 2003, SpayVac�-for-Wildlife, Inc., a not-for-profit
corporation, was formed in Princeton, New Jersey. Its primary purposes
are to:

1. Take SpayVac�-for-Deer through the regulatory process of the US
Food and Drug Administration, and

2. Produce and market SpayVac�-for-Deer at low cost

Meeting the regulatory requirements will require an investment of
perhaps as much as US$5 million. Because the estimated market is
small, SpayVac�-for-Wildlife, Inc., is seeking charitable
contributions to cover the regulatory-approval costs.

The time required before SpayVac�-for-Deer will be commercially
available will depend to a large degree on the availability of funds
to accomplish various tasks. Under favorable conditions,
SpayVac�-for-Deer could be on the market by 2008.

SpayVac�-for-Wildlife, Inc., can be contacted through its President,
Mark Fraker (250-656-3972) or its Vice-President, Robert Cervelli
(902-492-1819).

On what species has SpayVac� been tested?
The following species have been tested as of May 2001: Fallow Deer
(Dama dama), White-tailed Deer (Odocoileus virginianus), Black-tailed
Deer (Odocoileus hemionus columbianus), Horses (Equus caballus),
Barbary Sheep (Ammotragus lervia), Grizzly Bears (Ursus arctos),
Wolves (Canis lupus), Grey Seals (Halichoerus grypus), Hooded Seals
(Cystophora cristata), Harp Seals (Phoca groenlandica), and Laboratory
Rabbits (Oryctolagus cuniculus).

Who can I contact for more information?

Wildlife Applications:
Mark A. Fraker, President
SpayVac�-for-Wildlife, Inc. and
TerraMar Environmental Research Ltd.
Sidney, British Columbia, Canada
tel: 250-656-3972
fax: 250-656-3474
e-mail: maf(a)spayvac.org

SpayVac� Product Information:
Robert Cervelli, Vice-President
SpayVac�-for-Wildlife, Inc. and
ImmunoVaccine Technologies Inc.
Halifax, Nova Scotia, Canada
tel: 902-492-1819
fax: 902-492-0888
e-mail: rlc(a)spayvac.org

The way forward

The Project Team
In pursuing FDA approval for SpayVac�, SFW is undertaking the same
type of job that a pharmaceutical company would undertake. To achieve
our goal, we will employ an experienced team of specialists 1) to
provide ongoing scientific expertise and 2) to assist in negotiating
the maze of regulatory requirements. In addition to the involvement of
scientists who have been key in the research and development of
SpayVac�, we are in discussion with a consulting group that has the
critical pharmaceutical development and registration expertise. Key
project team members are:
SpayVac�-for-Wildlife, Inc. (SFW):

Mark A. Fraker (M.A., Zoology, Botany, Chemistry, President /
Treasurer, SFW) conducted the Fallow Deer research in Canada and
helped to initiate trials of SpayVac� on White-tailed Deer in several
US locations. A practicing biologist for >30 years, Mr. Fraker will
have overall responsibility for coordinating the SpayVac� Team,
developing a fund-raising program to cover the costs of regulatory
trials, and developing cooperative arrangements with potential
collaborators.
Robert L. Cervelli, (M.Sc. Forestry, Botany, Vice-President /
Secretary, SFW) is a founder and VP, Product Development, for IVT.
With over 16 years� experience as a life sciences business executive
and a successful track record in biotechnology company management, Mr.
Cervelli will oversee the commercialization of SpayVac�, including
manufacturing, distribution, and market acceptance, as well as
assisting with public relations and fund raising.
ImmunoVaccine Technologies, Inc.:

Robert G. Brown (B.Sc., Ph.D., Microbiology) was George S. Campbell
Professor of Cellular Biology at Dalhousie University and is currently
Chief Science Officer, IVT. As leader of the original research team,
Dr. Brown has participated in all aspects of SpayVac��s development,
including vaccine formulation, field trials, and basic studies of the
liposome technology that underlies SpayVac��s extraordinary
performance.
Pharmaceutical Industry Consultants:
The consulting group selected will be thoroughly experienced regarding
FDA requirements and pharmaceutical industry manufacturing and testing
practices.

Funding Sources
To keep the cost of SpayVac� low enough to encourage its use, we are
seeking charitable contributions to fund the FDA-approval process.
Potential sources include:

Foundations with an interest in animal welfare and/or biodiversity,
Insurance companies, which pay millions of dollars in deer-collision
claims,
Interested individuals in communities with overabundant deer,
Animal health companies interested in good will generated by such a
project, and
Government agencies, such as the USDA�s National Wildlife Research
Center.


From: Derek Moody on 5 Mar 2007 07:13
In article <1gonu2l7oku69ksa1vr1ns79fsa9rp0kkf(a)4ax.com>, Derek Moody
<URL:mailto:thisistheBDC(a)derekmoody.con> wrote:

Not one of mine. Pete the troll forged it.

> SpayVac� is a contraceptive vaccine that has proven highly effective

As Pete never reads what he posts and desires only to provoke argument
it is safest to assume that anything he espouses is at least unsafe
and probably malicious.

Cheerio,

--

>> derek(a)farm-direct.co.uk
>> http://www.farm-direct.co.uk/

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