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U.S. Army Medical Materiel Development Activity

Special Immunizations Program

Mission:

Offer selected Investigational New Drug (IND) vaccines to both military and civilian personnel at risk for pathogen and toxin exposure. Vaccines are offered on a volunteer basis under FDA-approved protocols as adjunct protection to other safety measures. Additionally, the program serves as a potential platform to introduce new IND products in support of military operations and other government agencies.

Vision:

Right Solution, Right Place, Right Time!


Western Equine Encephalitis (WEE)

Western Equine Encephalitis Virus (WEEV) is an alphavirus that is closely related to Eastern Equine Encephalitis and Venezuelan Equine Encephalitis viruses. It was first isolated in 1930 from very ill horses in the San Joaquin Valley in California. There is no treatment for WEE other than supportive care, meaning prophylactic vaccination is the best approach for those who may be exposed.

Primarily found in the U.S. and Canada, west of the Mississippi River, it was an important human and veterinary pathogen in the early to mid-20th century. However, as the 20th century progressed, human WEE incidence in the U.S. and Canada declined precipitously, with the last case in North America reported in 1998.

Naturally acquired WEEV (by mosquito bite) is less virulent for adult humans than for infants and the elderly. Symptoms usually begin with malaise, headache and fever, followed by nausea and vomiting. Over the next few days, drowsiness or delirium progresses into coma. Patients with the most severe disease usually die within the first week of clinical illness, with case fatalities averaging 10 percent. Most adults recover completely, but it may take months to years to fully recuperate from chronic fatigue, recurrent headaches, emotional issues and impaired concentration.

Licensed vaccinations are available for equines, but not for human use. The only vaccine approved for use in humans has been offered on a limited, voluntary basis in the SIP as an IND product under FDA and IRB approval. This IND vaccine is scheduled to be inactivated soon due to lack of interest and funding for further development or manufacture.

Sources: https://www.health.state.mn.us/diseases/weencephalitis/wee.html

MEDICAL COUNTERMEASURES, Chapter 21, by Janice M. Rusnak, MD; Ellen F. Boudreau, MD; Matthew J. Hepburn, MD; James W. Martin, MD, FACP; and Sina Bavari, PhD.

Product information

  • Western Equine Encephalitis (WEE) vaccine, inactivated, IND 2013

The inactivated WEE vaccine (TSI-GSD 210) is a lyophilized inactivated vaccine originally manufactured by the National Drug Company. The current product was manufactured at the Salk Institute in 1991. It has been administrated to at-risk personnel at Fort Detrick, Maryland, since the 1970s under IND 2013.

Publication

  1. Keshtkar-Jahromi M, Reisler RB, Haller JM, et al. The Western Equine Encephalitis Lyophilized, Inactivated Vaccine: An Update on Safety and Immunogenicity. Front Immunol. 2020 Nov 9;11:555464. PMID: 33240257.
  2. Turell MJ, O'Guinn ML, Parker MD. 2003. Limited potential for mosquito transmission of genetically engineered, live-attenuated western equine encephalitis virus vaccine candidates. Am J Trop Med Hyg 68:218-221.

Venezuelan Equine Encephalitis (VEE)

Venezuelan Equine Encephalitis Virus (VEEV) is an alphavirus that is closely related to Western Equine Encephalitis and Eastern Equine Encephalitis viruses. It was first isolated in the Guajira peninsula of Venezuela in 1938. The virus is most commonly spread to humans by mosquitoes who have bitten an infected animal. There is no treatment for VEE other than supportive care, meaning prophylactic vaccination is the best approach for those who may be exposed.

It is primarily found in Central and South America. An outbreak of VEE occurred in Venezuela in 1995, beginning in the northwest region of Venezuela, spreading to the Guajira peninsula and then to Colombia. The resulting epidemic resulted in an estimated 13,000 plus cases in humans and an unknown number of equine deaths.

VEE may cause severe flu-like symptoms, including general malaise, spiking fevers, chills, severe headache, photophobia (sensitivity or intolerance to light) and muscle pain for one to three days. Nausea, vomiting, cough, sore throat and diarrhea may follow. Illness may be further complicated by convulsions and other neurological symptoms. Inflammation of the brain develops in a small percentage of those infected (less than four percent of children, less than one percent of adults).

Licensed vaccinations are available for equines, but none for humans. The only vaccines approved for use in humans have been offered on a limited, voluntary basis in the SIP as an IND product under FDA and IRB approval. This IND vaccine is scheduled to be inactivated soon due to lack of interest and funding for further development or manufacture.

Source: http://www.cfsph.iastate.edu/DiseaseInfo/disease.php?name=venezuelan-equine-encephalomyelitis&lang=en

Source: https://www.cdc.gov/mmwr/preview/mmwrhtml/00039070.htm

MEDICAL COUNTERMEASURES, Chapter 21, by Janice M. Rusnak, MD; Ellen F. Boudreau, MD; Matthew J. Hepburn, MD; James W. Martin, MD, FACP; and Sina Bavari, PhD.

Product information

  • Venezuelan Equine Encephalitis (VEE) TC-83 vaccine, live attenuated, IND 142
  • Venezuelan Equine Encephalitis (VEE) C-84 vaccine, inactivated, IND 914

Both a live attenuated VEE vaccine (TC-83) and an inactivated VEE vaccine (C-84) are available under INDs 142 and 914 respectively. TC-83 was manufactured at the National Drug Company in Swiftwater, Pennsylvania in 1965. At-risk laboratory workers at Fort Detrick, Maryland, have received the TC-83 vaccine since 1963. The C-84 formalin inactivated vaccine is made from the TC-83 production seed. The vaccine is then inactivated with formalin and, like TC-83, the resultant product is freeze-dried. C-84 vaccine has been used in at-risk laboratory workers at Fort Detrick as a booster for those individuals who had received the TC-83 vaccine and had lower than expected immune-response.

Publication

  1. Pittman PR, Makuch RS, et al. Long-term duration of detectable neutralizing antibodies after administration of live-attenuated VEE vaccine and following booster vaccination with inactivated VEE vaccine. Vaccine. 1996 Mar; 14 (4):337-43. PMID: 8744562.
  2. Engler RJ, Mangiafico JA, Jahrling P, et al. Venezuelan equine encephalitis-specific immunoglobulin responses: live attenuated TC-83 versus inactivated C-84 vaccine. J Med Virol. 1992 Dec; 38 (4):305-10. PMID: 1474379.
  3. Edelman R, Ascher MS, Oster CN, Ramsburg HH, Cole FE, Eddy GA. Evaluation in humans of a new, inactivated vaccine for Venezuelan equine encephalitis virus (C-84). J Infect Dis. 1979 Nov; 140 (5):708-15. PMID: 528788.
  4. Rusnak JM, Glass PJ, Weaver SC, et al. Approach to strain selection and the propagation of viral stocks for Venezuelan equine encephalitis virus vaccine efficacy testing under the animal rule. Viruses. 2019; 11 (9):pii E807.
  5. Erwin-Cohen RA, Porter AI, Pittman PR, Rossi CA, DaSilva L. 2017. Human transcriptome response to immunization with live-attenuated Venezuelan equine encephalitis virus vaccine (TC-83): Analysis of whole blood. Human Vaccines & Immunotherapeutics 13:169-79.
  6. Erwin-Cohen RA, Porter AI, Pittman PR, Rossi CA, DaSilva L. Host responses to live-attenuated Venezuelan equine encephalitis virus (TC-83): Comparison of naive, vaccine responder and nonresponder to TC-83 challenge in human peripheral blood mononuclear cells. Human Vaccines and Immunotherapeutics 2012 Aug, 8 (8): 1053-1065.

Q fever (“Query” Fever, from when the cause was unknown)

Q fever is a highly infectious disease caused by a bacteria called Coxiella burnetii. Humans are infected by breathing in dust contaminated by infected animal feces, urine, milk and birth products, typically from cattle, sheep or goats. People may also get Q fever by eating contaminated, unpasteurized dairy products. Q fever is most commonly found in Australia, but has been a nationally notifiable disease in the U.S. since 1999.

Q fever infection can be mild to severe and is characterized by flu-like symptoms. In more severe cases, pneumonia or hepatitis may develop and the patient may suffer from an ongoing, chronic disease. Chronic disease may manifest many months or years after the primary infection, with the most frequent and serious side effect being endocarditis, an infection of the heart’s inner lining and/or valves, which can be fatal if not treated correctly.

No FDA-licensed vaccine is currently available for vaccination against Q fever in the U.S. However, a vaccine approved in Australia (Q-Vax, manufactured by CSL Ltd, Parkville, Victoria, Australia, and currently owned by Seqirus) has been demonstrated to be safe and effective for preventing Q fever. Q-Vax was developed from a similar IND vaccine (NDBR 105) that has been used in at-risk researchers at Fort Detrick, Maryland, since 1965. NDBR 105 vaccinations have been offered on a limited, voluntary basis in the Special Immunization Program as an IND product under FDA approval. This IND vaccine is scheduled to be inactivated soon due to lack of interest and funding for further development or manufacture.

Source: https://www.cdc.gov/qfever/index.html

MEDICAL COUNTERMEASURES, Chapter 21, by Janice M. Rusnak, MD; Ellen F. Boudreau, MD; Matthew J. Hepburn, MD; James W. Martin, MD, FACP; and Sina Bavari, PhD

Production Information

  • Q Fever vaccine, inactivated, IND 610

The NDBR 105 Q fever vaccine is an inactivated, lyophilized vaccine. It has been used for at-risk laboratory workers under IND 610. Skin testing is required before vaccination to identify persons with prior exposure to Q fever by injecting a small amount of diluted NDBR 105 intradermally (within or between layers of the skin) in the forearm. Vaccination with Q fever should not be used in persons with a positive skin test due to the risk of severe reaction at the vaccine site.

Tularemia

Tularemia is caused by the bacterium Francisella tularensis. While Tularemia can infect both animals and people, rabbits, hares, and rodents are the most susceptible. Humans can acquire tularemia through skin contact of infected animals; bites of infected arthropods (deerflies, mosquitoes, or ticks); ingestion of contaminated food or water (less commonly); or inhalation of aerosolized agent such as dust from infected animal secretions. Tularemia is not transmissible person-to-person.

Tularemia disease can range from mild to severe, and symptoms vary depending on how the bacteria was able to enter the body. Most cases of naturally occurring tularemia are ulceroglandular disease, involving an ulcer at the infection sites and swollen lymph glands. All types of Tularemia cause fever, but also other symptoms such as chills, headache, sore throat, tonsillitis, inflammation in the eye and general malaise. Occasionally, patients with tularemia present with a fever and a systemic illness without evidence of an infection site. Pulmonary disease can also occur naturally. In the U.S., 93 to 314 cases of tularemia have been reported yearly from 2008 to 2018, with a recent uptick over the last four years, ranging from 229 to 314.

Tularemia disease is relatively rare and can be difficult to diagnose, but administration of antibiotics and early treatment is effective for naturally acquired disease. Licensed vaccinations against infection are not available. The only vaccine approved for use in humans has been offered on a limited, voluntary basis in the Special Immunization Program as an IND product under FDA approval. This IND vaccine is scheduled to be inactivated soon due to lack of interest and funding for further development or manufacture.

Source: https://www.cdc.gov/tularemia/index.html

MEDICAL COUNTERMEASURES, Chapter 21, by Janice M. Rusnak, MD; Ellen F. Boudreau, MD; Matthew J. Hepburn, MD; James W. Martin, MD, FACP; and Sina Bavari, PhD.

Product Information

  • Tularemia vaccine, live attenuated, IND 157

The live attenuated tularemia vaccine, Live Vaccine Strain (LVS), was administrated to at-risk laboratory personnel in Fort Detrick, Maryland, between 1959 and 1969. In 1961, commercial production of LVS was initiated by the National Drug Company, Swiftwater, Pennsylvania. This vaccine was designated NDBR 101, and is given as an investigational drug under IND 157.

The live attenuated NDBR 101 tularemia vaccine is administered by scarification, with 15 to 30 pricks in the forearm using a forked needle.

Publication:

Tularemia Publications:

  1. M Hepburn, B Purcell, et al. Live Vaccine Strain Francisella tularensis Is Detectable at the Inoculation Site but Not in Blood after Vaccination against Tularemia, Clinical Infectious Diseases, Volume 43, Issue 6, 15 September 2006, pages 711-716.
  2. Burke DS. Immunization against tularemia: analysis of the effectiveness of live Francisella tularensis vaccine in prevention of laboratory-acquired tularemia, J Infect Dis, 1977, vol. 135 (pg. 55-60).
  3. Mulligan MJ, Stapleton JT, Keitel WA, Frey SE, et al. Tularemia vaccine: Safety, reactogenicity, "Take" skin reactions, and antibody responses following vaccination with a new lot of the Francisella tularensis live vaccine strain - A phase 2 randomized clinical Trial. DMID 08-0006 Tularemia Vaccine Study Group. Vaccine. 2017 Aug 24; 35 (36):4730-4737 PMID: 28750854.
  4. Green M, Choules G, et al. Efficacy of the live attenuated Francisella tularensis vaccine (LVS) in murine model of disease. Vaccine 23 (2005) 2680-2686.
  5. Rohmer, et al. (2006) Potential Source of Francisella tularensis Live Vaccine Strain Attenuation Determined by Genome Comparison. Infection and Immunity; Vol. 74, No. 12, Dec. 2006, p. 6895-6906.
  6. E. Salomonsson, et al. (2009) Reintroduction of Two Deleted Virulence Loci Restores Full Virulence to the Live Vaccine Strain of Francisella tularensis; Vol. 77, No. 8, Aug. 2009, p. 3424-3431.
  7. Hepburn MJ, Friedlander AM, Dembek ZF. Tularemia. In: Dembek ZF, ed. Medical Aspects of Biological Warfare, rev ed. Falls Church, VA: Office of the Surgeon General United States Army and Washington, DC: Borden Institute, Walter Reed Medical Center. 2007: 167-184.
  8. Fuller CL, Brittingham KC, Hepburn MJ, Martin JW, Pettit PL, Pittman PR, Bavari S. 2006. Dominance of human innate immune responses in primary Francisella tularensis live vaccine strain vaccination. Letter to the editor. J Allergy Clin Immunol 117:1186-1188.
  9. Hepburn M, Coyne SR, Norwood DA, Ulrich MP. 2005. Rapid diagnostic techniques for detecting Francisella tularensis live vaccine strain from whole blood and swab samples. Abstracts of the 105th General Meeting of the American Society for Microbiology, p. 136.
  10. Paranavitana C; Zelazowska E; Dasilva L; Pittman PR; Nikolich M. Th17 cytokines in recall responses against Francisella tularensis in humans. Journal of Interferon and Cytokine Research 2010 July; 30 (7): 471-6.
  11. Paranavitana C, DaSilva L, Vladimirova A, Pittman PR, Velauthapillai M, Nikolich M. Transcriptional profiling of recall responses to Francisella live vaccine strain. Pathog Dis. 2014;70 (2):141-52.


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Last Modified Date: 08/24/2021
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