Field Test of GonaCon™ Immunocontraceptive Vaccine in Free-Ranging Female White-Tailed Deer

Gionfriddo, James P.; Eisemann, John D.; Sullivan, Kevin; Healey, Ronald S.; Miller, Lowell A.

doi:10.5070/v422110148

Cited by 4 publications

(3 citation statements)

References 7 publications

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“…In a 7-year review of GonaCon studies in various species (using AdjuVac as the adjuvant), Miller et al (2008) state "The most common report is that there is no visible injection site reaction, or that there is a non-visible but palpable lump underneath the skin at the site of the injection." Two field studies using the same vaccine in white-tailed deer resulted in similar findings as well as "considerable injection-site reaction deep in the muscle" when the site was dissected (Gionfriddo et al 2006). These findings are similar to ours where injection site reactions were more readily visible during necropsy.…”

Section: Discussionsupporting

confidence: 85%

Effects of two porcine zona pellucida immunocontraceptive vaccines on ovarian activity in horses

et al. 2013

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Feral horse population growth rates as high as 25% are of concern to those responsible for managing range lands as well as conservation groups. Current methods to control these populations include adoption and long-term holding, which are both costly and controversial. Porcine zona pellucida (pZP) immunocontraception may have the greatest potential to control fertility because it has proven to be effective in other studies and vaccines are easy and safe to administer. One pZP vaccine formulation, SpayVac 1 (ImmunoVaccine Technologies, Inc., Halifax, NS, Canada), has demonstrated single-dose, multi-year contraceptive efficacy in other wildlife species, which would make it both practical and economical for field application. Over a 7-month period during the breeding season, we assessed the effect on ovarian activity of 2 formulations of SpayVac, 1 non-aqueous with modified Freund's adjuvant (MFA) and the other, an aqueous emulsion with MFA, compared to controls (n ¼ 7 per group). Comparative reproductive parameters included serum concentrations of progesterone (P 4 ) determined by enzyme-linked immunosorbent assay (ELISA), ovarian activity assessed by transrectal ultrasound and palpation, as well as gross and histological examination of ovaries upon necropsy (n ¼ 9 or 3 mares from each group) or after ovariectomy (n ¼ 12 or 4 mares from each group). We determined serum antibody titers using ELISA. Mean serum concentrations of P 4 were less in the non-aqueous MFA treatment group compared to control mares (P < 0.025). Ovaries collected from control mares weighed more (P ¼ 0.002) and had greater variation (P ¼ 0.003) than those from either vaccinated group. Both treatment groups also had smaller ovaries and fewer follicles compared to controls (P < 0.001). Three to 4 months after vaccination, 93% of SpayVac-injected mares ceased cycling; whereas all control mares continued to cycle throughout the study. Relatively constant antibody titers were reached by week 6 post-vaccination, although we found appreciable variation within treatment groups, especially 4-8 weeks post-vaccination. Based on our study, the SpayVac formulations impair ovarian function but do not affect other major organ systems, and could provide a safe and effective immunocontraceptive option for mares. Additional research to elucidate the vaccine's mechanism of action, actual contraceptive efficacy, and long-term effects are still needed. Ó 2013 The Wildlife Society.

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Section: Discussionsupporting

confidence: 85%

Effects of two porcine zona pellucida immunocontraceptive vaccines on ovarian activity in horses

et al. 2013

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“…Efficacy data will be required for the end-use formulation. This requirement will be met by submission of data from pen studies with white-tailed deer at Pennsylvania State University (Miller et al 2000;Miller and Killian 2001) and from a field trial conducted in Maryland under Good Laboratory Practices (Gionfriddo et al 2006). The pen studies showed 90-100% effectiveness in reducing fertility during the first year and~70% effectiveness during the second year.…”

Section: Development and Registration Of Gonaconmentioning

confidence: 99%

Registration of wildlife contraceptives in the United States of America, with OvoControl and GonaCon immunocontraceptive vaccines as examples

et al. 2008

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Overabundant wildlife populations have the potential to adversely affect wildlife habitats or pose risks to human health and safety through disease transmission and collisions with vehicles and aircraft. Traditional methods for reducing overabundant wildlife, such as hunting and trapping, are often restricted or infeasible in urban and suburban areas. Additional management options are needed. For the past 15 years, scientists with the US Department of Agriculture’s (USDA) Wildlife Services’ National Wildlife Research Center have been developing and testing contraceptive agents. This research has resulted in the development of several reproductive inhibitors and has forced regulatory bodies to determine where the regulatory authority for wildlife contraceptives will reside. The regulatory authority for contraceptives for wildlife and feral animals has recently been moved from the US Food and Drug Administration (FDA) to the US Environmental Protection Agency (EPA). The first contraceptive registered by the EPA since this move was OvoControl-G for reducing the hatchability of Canada goose eggs. OvoControl was registered in 2005 by Innolytics, LLC working in cooperation with the National Wildlife Research Center. A similar product, OvoControl-P, was registered in 2007 as a contraceptive technique for pigeons. Another product developed by the National Wildlife Research Center, GonaCon immunocontraceptive vaccine, is in the registration process for managing white-tailed deer populations. This manuscript will describe the products that have been and are currently undergoing registration as contraceptives in the United States of America, and the data required for those products.

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“…), it appears that if a visible reaction occurs, it is because there has been a previous T cell response to a killed bacteria in a vaccine, or the animal has a bacterial infection which can cause the T cell response to our vaccine. In two field studies with white-tailed deer, there were no visible injection site reactions on the surface; however, when the injection site is dissected, there was considerable injection-site reaction deep in the muscle (Gionfriddo 2006). This is in contrast to the target safety study at Penn State (Killian et al 2006b), where there was no visible injection-site reaction and the granulomas at the dissected injection site were minimal.…”

Section: Injection Site Reactionsmentioning

confidence: 86%

Immune Mechanisms and Characterization of Injection Site Reactions Involved in the Multi-Year Contraceptive Effect of the GonaCon™ Vaccine

Miller¹,

Fagerstone²,

Kemp³

et al. 2008

vertebrate_pest_conference

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The term "vaccine" has traditionally been associated with establishing immunity (antibodies) to a disease. This immunity is usually developed following administration of killed microorganisms. Disease vaccines typically require 1 to 3 injections, depending on the antigen design and efficacy of the vaccine. The effectiveness of the disease vaccine depends on the immune response developed by the host following exposure to the disease organism. The immunocontraceptive vaccine GonaCon ™ is designed to produce immunity to the "self" hormone (GnRH), which is essential to reproductive activity in the mammal. Antibodies to GnRH reduce its biological activity resulting in infertility of both sexes. GonaCon ™ 's effectiveness as a single-injection immunocontraceptive wildlife vaccine depends on 4 factors. The first is the use of a large foreign mollusk protein in the GnRH conjugate. Second is the design of mollusk/GnRH protein conjugate that presents the GnRH antigen in a repetitious fashion. This design mimics the "danger signal" found in bacterial pathogens to which the animal has been previously exposed. Third is the addition to the vaccine of micrograms of Mycobacterium avium, which is ubiquitous in the environment and activates memory cells. The fourth factor is use of a water-in-oil emulsion, which provides a depot at the injection site, allowing a slow release of the vaccine. With this formulation, the vaccine is presented to the body as a "chronic infection", even though it is not infectious. The granuloma that normally develops at the injection site plays a prime role in the host's defense against this "chronic infection". A WHO report on the use of the alum adjuvant in human vaccines states that "development of a small granuloma is inevitable with vaccines adjuvanted with aluminum, and is to be considered necessary to the efficacy of the adjuvant." Researching GonaCon ™ for use in companion animals, NWRC has looked at many different adjuvants intended to reduce the injection site reaction while at the same time retaining an effective vaccine. This paper reports on the role of the adjuvant and the injection site on the effectiveness of the vaccine.

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Field Test of GonaCon™ Immunocontraceptive Vaccine in Free-Ranging Female White-Tailed Deer

Cited by 4 publications

References 7 publications

Effects of two porcine zona pellucida immunocontraceptive vaccines on ovarian activity in horses

Effects of two porcine zona pellucida immunocontraceptive vaccines on ovarian activity in horses

Registration of wildlife contraceptives in the United States of America, with OvoControl and GonaCon immunocontraceptive vaccines as examples

Immune Mechanisms and Characterization of Injection Site Reactions Involved in the Multi-Year Contraceptive Effect of the GonaCon™ Vaccine

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