Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Impaired healing, Injection site erythema, Injection site induration, Injection site scab, Intensive care
Clinical narrative: This case was initially received on 03 March 2009 and follow-up was received on 05 March 2009. Additional follow-up was received on 10 March 2009. A 20 year-old male military service member was diagnosed with acute myelogenous leukemia (AML) on 28 January 2009. The patient received smallpox vaccine (manufacturer and lot numb not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Chemical Biological Medical System's Joint Vaccine Acquisition Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 March 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The Centers for Disease Control and Prevention (CDC) are coordinating viral load and serologic immune response testing. Physicians from the military and the CDC are collaborating on the patient's care plan. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. This follow-up report was received from a healthcare provider at a hospital on 30 March 2009. The patient was diagnosed with progressive vaccinia on 03 March 2009. He was initially hospitalized on 25 January 2009 in a civilian facility and was transferred to a military facility on 28 January 2009. He remains hospitalized and is still undergoing treatment. He was neutropenic on his initial admission. He was presumably neutropenic prior to admission but actual date of onset is unknown. A bone marrow biopsy was consistent with AML, MO. PCR and culture from the primary vaccination site and surrounding satellite lesions were positive for vaccinia virus (testing performed by the CDC Poxvirus Program). A copy of the the SF600 Smallpox Vaccination Screening Form was included iwth the followup report. According to this form, the date of administration of smallpox vaccine was 13 January 2009 and the lot number reported as "W04003A". This follow-up report was received from a healthcare provider at a medical center on 11 May 2009. The patient remains hospitalized. The patient had bilateral below-knee amputation (BKA) secondary to dry gangrene which was a result of the multiple vasopressors the patient received during his treatment in the Intensive Care Unit. The patient's vaccinia lesion appears to be resolving by clinical and laboratory parameters. The following information was obtained from a literature article received on 19 May 2009. The patient's date of vaccination was confirmed as 13 January 2009. The diagnosis was further clarified as acute myelogenous leukemia MO (AML MO). After the diagnosis, the patient underwent two rounds of chemotherapy (30 January 2009 and 13 February 2009) with cytrarbine, idarubicin, and dexamethasone. Prior to the initial chemotherapy treatment, the smallpox vaccination site was reported to have a central crust, and measured approximately 1 cm in diameter with some surrounding erythema. By 02 March 2009, the smallpox vaccine site had failed to heal and had progressed in size to approximately 4 x 4 cm with minimal erythema and induration. Blood serum tests showed equivocal to absent levels of anti-orthopoxvirus immunoglobulin G (IgG) and immunoglobulin M (IgM) by enzyme - linked immunosorbent assay. On 03 March 2009, the patient's smallpox vaccination site was treated with imiquimod which was applied directly to the site. The patient received subsequent treatments with imiquimod (5%, 12.5 mg) daily from 24 March 2009 to 12 May 2009. The patient received Vaccinia Immune Globulin Intravenous (Human) (VIGIV) (Cangene Corporation) (dose 6,000 U/kg) on 04 March 2009. Subsequent treatments with VIGIV were administered once per day as follows: 6,000 U/kg on 11 March, 20 March, 1 April, 3 April, 6 April, 8 April, and 18 April 2009; 18,000 U/kg on 9 April 2009; and 24,000 U/kg on 24 March, 14 April, 23 April, 28 April and 8 May 2009. The patient was also treated with oral and topical ST-246 (Siga Technologies) under an Emergency Investigational New Drug (E-IND) application. Treatment with oral ST-246 began on 05 March 2009. The initial dose was 400 mg administered daily. The dose was increased to 800 mg on 20 March 2009 and to 1200 mg on 25 March 2009. The dose was increased to obtain more optimal drug levels. Topical ST-246 (1%, 0.5 ml) was first administered on 06 March 2009. Subsequent treatments were administered twice daily from 07 March 2009 to 20 April 2009 and then once daily from 21 April 2009 to 12 May 2009. On 02 March 2009, the patient became septic Pseudomonas aeruginosa, likely from a perirectal abscess. He was intubated with maximal vasopressor support and received multiple antibiotics and stress dose corticosteroids. He developed multiorgan failure and had venovenous hemodialysis. The patient did improve over the next 12 days. The size of lesion at the patient's vaccination had remained unchanged, but the crust had separated. As the patient's steroid dose was decreasing, satellite lesions appeared around the vaccination site and on 18 March 2009, viral DNA was detected in the patient's blood. On 26 March 2009, 200 mg of CMX001 (Chimerix, Inc.) was administered under a second E-IND. The patient received subsequent treatments with 100 mg of CMX001 on 1 April, 7 April, 13 April, 20 April and 27 April 2009. From 24 March 2009, the lesions continued to crust and the scabs separated. Blood viral DNA resolved on 29 March 2009. On 10 April 2009, methicillin-resistant Staphylococcus aureus was cultured from a biopsy of the lesions. By 01 May 2009, most of the scabs had separated (or were removed manually) and displayed healing. The patient was on contact isolation from 21 February 2009 until 05 May 2009 for both Clostridium difficile infection and progressive vaccinia infection. No cases of contact transmission of vaccinia virus occurred in health care workers treating the patient or other close contacts. Multiple clinical specimens were sent to CDC for evaluation during the course of the patient's hospitalization. After 23 April 2009, swabs from the vaccination site and satellite lesions showed significantly reduced or absent levels of viral DNA and no viable virus was detected after 2 April 2009. List of Documents held by sender: DoD SF600 Smallpox Vaccination Screening Form.