Randomized, double-blind, placebo-controlled phase 3 trial of the safety and tolerability of IC51, an inactivated Japanese encephalitis vaccine

Journal of Infectious Diseases

Volumn 198, Issue 4, 2008, Pages 493-499

  Tauber, E ^a   Kollaritsch, H ^b   Von Sonnenburg, F ^c   Lademann, M ^d   Jilma, Bernd ^a   Firbas, C ^a   Jelinek, T ^e   Beckett, C ^g   Knobloch, J ^f   McBride, W J H ⁱ   Schuller, E ^a   Kaltenbock A ^a   Sun, W ^h   Lyons, Arthur G ^h  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

^c UNIVERSITY OF MUNICH   (Germany)

^d UNIVERSITY OF ROSTOCK   (Germany)

^e Berlin Center for Travel and Tropical Medicine   (Germany)

^f UNIVERSITY OF TÜBINGEN   (Germany)

^g NAVAL MEDICAL RESEARCH CENTER   (United States)

^h WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

ⁱ JAMES COOK UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM HYDROXIDE; CETIRIZINE; IC 51; INACTIVATED VACCINE; JAPANESE ENCEPHALITIS VACCINE; PLACEBO;

ABSCESS; ACUTE CORONARY SYNDROME; ADNEXA DISEASE; ADULT; AGED; ALLERGIC REACTION; APPENDICITIS; ARTICLE; BACKACHE; BRONCHITIS; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CYST RUPTURE; CYSTITIS; DERMATOMYOSITIS; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPIDEMIC ENCEPHALITIS; FACE FRACTURE; FACE INJURY; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; FOLLOW UP; GASTROENTERITIS; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; IMMUNIZATION; INFECTION; INFESTATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJURY; INTOXICATION; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; MYALGIA; NAUSEA; NEUROLOGIC DISEASE; OVARY CYST; OVARY DISEASE; OVARY TORSION; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROCTALGIA; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RECTUM HEMORRHAGE; RESPIRATORY TRACT DISEASE; RHINITIS; RHINOPHARYNGITIS; SHOCK; SINUSITIS; SKIN ALLERGY; SKIN DISEASE; SORE THROAT; SUBCUTANEOUS TISSUE DISORDER; SYMPTOM; THORAX DISEASE; THORAX PAIN; ULNA FRACTURE; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; UROLITHIASIS; URTICARIA; VERO CELL; VOMITING;

ADULT; AGED; DOUBLE-BLIND METHOD; ENCEPHALITIS VIRUS, JAPANESE; ENCEPHALITIS, JAPANESE; FEMALE; HUMANS; JAPANESE ENCEPHALITIS VACCINES; MALE; MIDDLE AGED; PLACEBOS; SAFETY; VACCINES, INACTIVATED;

EID: 48749089355     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/590116     Document Type: Article

References (30)

1. Advisory Committee on Immunization Practices. Prevention and control of influenza: part I, vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 1993; 42(RR-6):1-14.
2. Simpson T, Meiklejohn G. Sequelae of Japanese B encephalitis. Am J Trop Med Hyg 1947; 27:727-31.
3. Oya A, Kurane I. Japanese encephalitis for a reference to international travelers. J Travel Med 2007; 14:259-68.
4. Solomon T, Vaughn DW. Pathogenesis and clinical features of Japanese encephalitis and West Nile virus infections. Curr Top Microbiol Immunol 2002; 267:171-94.
5. Solomon T. Control of Japanese encephalitis - within our grasp? N Engl J Med 2006; 355:869-71.
6. Tsarev SA, Sanders ML, Vaughn DW, Innis BL. Phylogenetic analysis suggests only one serotype of Japanese encephalitis virus. Vaccine 2000; 18(Suppl 2):36-43.
7. Centers for Disease Control and Prevention. Travelers' health: yellow book. Chapter 4. Prevention of specific infectious diseases: Japanese encephalitis. 2007. Available at: http://wwwn.cdc.gov/travel/ yellowBookCh4-JapaneseEncephalitis.aspx. Accessed 11 January 2008.
8. Berg SW, Mitchell BS, Hanson RK, et al. Systemic reactions in U.S. Marine Corps personnel who received Japanese encephalitis vaccine. Clin Infect Dis 1997; 24:265-6.
9. Summary of product characteristics: JE-VAX.
10. Kamin W, Staubach P, Klär-Hlawatsch B, Erdnüss F, Knuf M. Anaphylaxis after vaccination due to hypersensitivity to gelatin. Klin Padiatr 2006; 218:92-4.
11. Robinson HC, Russell ML, Csokonay WM. Japanese encephalitis vaccine and adverse effects among travellers. Can Dis Wkly Rep 1991; 17:173-4, 7.
12. World Health Organization. WHO report of the bi-regional meeting on Japanese encephalitis (WHO SEA/WPR and PATHs JE Project). Bangkok, Thailand. 2005.
13. RxList: the Internet drug index. San Clemente. Je-Vax. Available at: http://www.rxlist.com/cgi/generic/jevax.htm. Accessed 10 January 2008.
14. Tsai TF. New initiatives for the control of Japanese encephalitis by vaccination: minutes of a WHO/CVI meeting, Bangkok, Thailand, 13-15 October 1998. Vaccine 2000; 18(Suppl 2):1-25.
15. Global Advisory Committee on Vaccine Safety, 9-10 June 2005. Wkly Epidemiol Rec 2005; 80(28):242-8. Available at: http://www.who.int/wer/ 2005/wer8028.pdf. Accessed 11 January 2008.
16. Srivastava AK, Putnak JR, Lee SH, Hong SP, Moon SB, Barvir DA, et al. A purified inactivated Japanese encephalitis virus vaccine made in Vero cells. Vaccine 2001; 19:4557-65.
17. Lyons A, Kanesa-thasan N, Kuschner RA, et al. A phase 2 study of a purified, inactivated virus vaccine to prevent Japanese encephalitis. Vaccine 2007; 25:3445-53.
18. Tauber E, Kollaritsch H, Korinek M, et al. Safety and immunogenicity of a Vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial. Lancet 2007; 370:1847-53.
19. Eckels KH, Yu YX, Dubois DR, Marchette NJ, Trent DW, Johnson AJ. Japanese encephalitis virus live-attenuated vaccine, Chinese strain SA14-14-2; adaptation to primary canine kidney cell cultures and preparation of a vaccine for human use. Vaccine 1988; 6:513-8.
20. Plesner AM, Ronne T. Allergic mucocutaneous reactions to Japanese encephalitis vaccine. Vaccine 1997; 15:1239-43.
21. Plesner A, Ronne T, Wachmann H. Case-control study of allergic reactions to Japanese encephalitis vaccine. Vaccine 2000; 18:1830-6.
22. Takahashi H, Pool V, Tsai TF, Chen RT. Adverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States. The VAERS Working Group. Vaccine 2000; 18:2963-9.
23. Andersen MM, Ronne T. Side-effects with Japanese encephalitis vaccine. Lancet 1991; 337:1044.
24. Ruff TA, Eisen D, Fuller A, Kass R. Adverse reactions to Japanese encephalitis vaccine. Lancet 1991; 338:881-2.
25. Sakaguchi M, Inouye S. Two patterns of systemic immediate-type reactions to Japanese encephalitis vaccines. Vaccine 1998; 16:68-9.
26. Ohtaki E, Murakami Y, Komori H, Yamashita Y, Matsuishi T. Acute disseminated enceahalomyelitis after Japanese B encephalitis vaccination. Pediatr Neurol 1992; 8:137-9.
27. Hennessy S, Liu Z, Tsai TF, et al. Effectiveness of live-attenuated Japanese encephalitis vaccine (SA14-14-2): a case-control study. Lancet 1996; 347:1583-6.
28. Liu ZL, Hennessy S, Strom BL, et al. Short-term safety of live attenuated Japanese encephalitis vaccine (SA14-14-2): results of a randomized trial with 26,239 subjects. J Infect Dis 1997; 176:1366-9.
29. Sohn YM, Park MS, Rho HO, Chandler LJ, Shope RE, Tsai TF. Primary and booster immune responses to SA14-14-2 Japanese encephalitis vaccine in Korean infants. Vaccine 1999; 17:2259-64.
30. Centers for Disease Control and Prevention. Inactivated Japanese encephalitis virus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 1993; 42(RR-1):1-15.