Safety and pharmacokinetic evaluation of intravenous vaccinia immune globulin in healthy volunteers

Clinical Infectious Diseases

Volumn 39, Issue 6, 2004, Pages 759-766

  Hopkins, Robert J ^a,f   Kramer, William G ^b   Blackwelder, William C ^c   Ashtekar, Minal ^a   Hague, Lynda ^a   Winker La Roche, Salome D ^a   Berezuk, Gregory ^d   Smith, David ^a   Leese, Philip T ^e  

^a DynPort Vaccine Company   (United States)

^b Kramer Consulting   (United States)

^c Biologics Consulting Group   (United States)

^d BAXTER HEALTHCARE CORPORATION   (United States)

^e Lenexa Phase 1 Unit   (United States)

^f Emergent Biosolutions   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN; UNCLASSIFIED DRUG; VACCINIA IMMUNOGLOBIN;

ABDOMINAL PAIN; ADULT; AGED; ANTIBODY TITER; ARTHRALGIA; ARTICLE; BACKACHE; BONE DISEASE; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTACT DERMATITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SAFETY; DYSPNEA; ERYTHEMA; FEASIBILITY STUDY; FEMALE; FLUSHING; FREEZE DRYING; GASTROINTESTINAL DISEASE; GEOMETRY; HEADACHE; HUMAN; HUMAN EXPERIMENT; INJECTION PAIN; MALE; MUSCULOSKELETAL DISEASE; NAUSEA; NORMAL HUMAN; NOSE CONGESTION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN DISEASE; SOMNOLENCE; SORE THROAT; THORAX DISEASE; TISSUE INJURY; TOOTH PAIN; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; VASCULAR DISEASE;

ANTIBODIES, VIRAL; FEASIBILITY STUDIES; FEMALE; HUMANS; IMMUNOGLOBULINS; IMMUNOGLOBULINS, INTRAVENOUS; INJECTIONS, INTRAMUSCULAR; MALE; VACCINIA; VACCINIA VIRUS;

EID: 4544367738     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/422998     Document Type: Article

References (26)

1. Dryvax Product Insert. Available at http://www.fda.gov/cber/label/ smalwye102502LB.pdf. Accessed 20 February 2004.
2. Rosenthal SR, Merchlinsky M, Kleppinger C, Goldenthal KL. Developing new smallpox vaccines. Emerg Infect Dis 2001; 7:920-6.
3. Weltzin R, Liu J, Pugachev KV, et al. Clonal vaccinia virus grown in cell culture as a new smallpox vaccine. Nat Med 2003; 9:1125-30.
4. Kempe CH. Studies on smallpox and complications of smallpox vaccination. Pediatrics 1960; 26:176-89.
5. Vaccinia immune globulin (human). In: Immunofacts. St. Louis, MO: Facts and Comparisons, Wolters Kluwer, 2004:236-8.
6. Barbero GJ, Gray A, Scott TF, et al. Vaccinia gangrenosa treated with hyperimmune vaccinal gamma globulin. Pediatrics 1955; 16:609-18.
7. Kozinn PJ, Siegel MM, Gorrie RA. Progressive vaccinia associated with a gamma-globulinemia and defects in immune mechanism. Pediatrics 1955; 16:600-8.
8. Douglas RG, Lynch EC, Spira M. Treatment of progressive vaccinia: use of methisazone, vaccinia immune serum globulin, and surgical debridement. Arch Intern Med 1972; 129:980-3.
9. Seth V, Malaviya AN, Gopalan PR, Ghai UP. Progressive vaccinia successfully treated with vaccinia immune globulin. Indian Pediatr 1978; 15:67-72.
10. Funk EA, Strausbaugh LJ. Vaccinia necrosum after smallpox vaccination for herpes labialis. South Med J 1981; 74:383-4.
11. Center for Disease Control and Preventions. Epidemiologic notes and reports disseminated vaccinia infection in a college student in Tennessee. MMWR Morb Mortal Wkly Rep 1982; 31:682-3.
12. RedfieJd RR, Wright DC, James WD, Jones TS, Brown C, Burke DS. Disseminated vaccinia in a military recruit with human immunodeficiency virus (HIV) disease. N Engl J Med 1987; 316:673-6.
13. Kesson AM, Ferguson JK, Rawlinson WD, Cunningham AL. Progressive vaccinia treated with ribavirin and vaccinia immune globulin. Clin Infect Dis 1997; 25:911-4.
14. Vaccinia (smallpox) vaccine: recommendations of the Immunization Practices Advisory Committee. MMWR Morb Mortal Wkly Rep 1991; 40(RR-14):1-10. Erratum in: MMWR Morb Mortal Wkly Rep 1992; 41:31.
15. Lane JM, Reuben FL, Neff JM, Millar JD. Complications of smallpox vaccination,1968: results of ten statewide surveys. J Infect Dis 1970; 122:303-9.
16. Greenberg M. Complications of vaccination against smallpox. Am J Dis Child 1947; 3:355-70.
17. Centers for Disease Control and Prevention (CDC) home page, smallpox vaccination and adverse events training module. Available at: http: //www.bt.cdc.gov/training/smallpoxvaccine/reactions/sitemap.htm. Accessed 20 February, 2004.
18. Lane JM, Ruben FL, Neff JM, Millar JD. Complications of smallpox vaccination, 1968: national surveillance in the United States. N Engl J Med 1969; 281:1201-8.
19. Morrell A, Schurch B, Ryser D, Hofer F, Skvaril F, Barandun S. In vivo behavior of gamma globulin preparations. Vox Sang 1980; 38:272-83.
20. Cytogam [package insert]. Gaithersburg, MD: MedImmune, 2004. Available at: http://www.medimmune.com/products/cytogam.asp. Accessed 20 February 2004.
21. Respigam [package insert]. Gaithersburg, MD: MedImmune, 2004. Available at: http://www.medimmune.com/products/respigam/index.asp. Accessed 20 February 2004.
22. Finlayson JS, Tankersley DL. Availability of intramuscular immunoglobulin. Lancet 1984; 2:296-7.
23. Gibaldi M, Perrier D. One-compartment model. In: Pharmacokinetics. 2nd ed. New York: Marcel Dekker, 1982:27-32.
24. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997; 8:1788-94.
25. Cantu TG, Hoehn-Saric EW, Burgess KM, et al. Acute renal failure associated with immunoglobulin therapy. Am J Kidney Dis 1995; 25: 228-34.
26. Hansen-Schmidt S, Silomon J, Keller F. Osmotic nephrosis due to high-dose immunoglobulin therapy containing sucrose (but not glycine) in a patient with immunoglobulin A nephritis. Am J Kidney Dis 1996; 28:451-3.