Safety and immunogenicity of a new chromatographically purified rabies vaccine in comparison to the human diploid cell vaccine

Journal of Travel Medicine

Volumn 11, Issue 4, 2004, Pages 195-200

  Arora, Ashoni ^a,b   Moeller, Larry ^a   Froeschle, James ^a  

^a KANSAS STATE UNIVERSITY   (United States)

^b NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHROMATOGRAPHICALLY PURIFIED RABIES VACCINE; DIPLOID CELL VACCINE; NEW DRUG; RABIES IMMUNOGLOBULIN; RABIES VACCINE; UNCLASSIFIED DRUG;

ADULT; ANTIBODY TITER; ARTICLE; CHROMATOGRAPHY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; ERYTHEMA; FEMALE; HUMAN; IMMUNOGENICITY; INFECTION; INJECTION SITE; INJECTION SITE PAIN; MALE; MYALGIA; NORMAL HUMAN; PAIN; PHASE 3 CLINICAL TRIAL; PROTEIN PURIFICATION; RABIES; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SEROCONVERSION; SKIN INDURATION; STUDENT; SYSTEMIC DISEASE; VACCINATION;

EID: 4043060659     PISSN: 11951982     EISSN: None     Source Type: Journal    
DOI: 10.2310/7060.2004.19001     Document Type: Article

References (22)

1. Plotkin S. Rabies. Clin Infect Dis 2000; 30:4-12.2.
2. World Health Organization. Wkly Epidemiol Rec 2002; 77:109-120.
3. Haupt W. Rabies - risk of exposure and current trends in prevention of human cases. Vaccine 1999; 17:1742-1749.
4. Centers for Disease Control. Human rabies prevention - United States. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1999; 48(RR-1):1-21.
5. Wiktor TJ, Plotkin SA, Koprowski H. Development and clinical trials of the new human rabies vaccine of tissue culture (human diploid cell) origin. Dev Biol Stand 1978; 40:3-9.
6. Centers for Disease Control. Systemic allergic reactions following immunization with human diploid cell rabies vaccine. MMWR 1984; 133:185-187.
7. Dreesen DW, Bernard KW, Parker RA, et al. Immune complex-like disease in 23 persons following a booster dose of rabies human diploid cell vaccine. Vaccine 1986; 4:45-49.
8. Anderson MC, Baer H, Frazier DJ, Quinnan GV. The role of specific IgE and β-propiolactone in reactions resulting from booster doses of human diploid cell rabies vaccine. J Allergy Clin Immunol 1987; 80:816-818.
9. Swanson MC, Rosanoff E, Gurwith M, et al. IgE and IgG antibodies to β-propiolactone and human serum albumin associated with urticarial reactions to rabies vaccine. J Infect Dis 1987; 155:909-913.
10. Fishbein DB, Yenne KM, Dreesen DW, et al. Risk factors for systemic hypersensitivity reactions after booster vaccinations with human diploid cell rabies vaccine: a nationwide prospective study. Vaccine 1993; 11:1390-1394.
11. Jaiiaroensup W, Lang J, Thipkong P, et al. Safety and efficacy of purified vero cell rabies vaccine given intramuscularly and intradermally. (Results of a prospective randomized trial.) Vaccine 1998; 16:1559-1562.
12. WHO Expert Committee on Biological Standardization. 46th Report. WHO Tech Rep Ser 1998; 872:1-90.
13. Montagnon BJ, Fanget B, Nicolas AJ. The large-scale cultivation of vero cells in microcarrier culture for virus vaccine production: preliminary results for killed poliovirus vaccine. Dev Biol Stand 1981; 47:55-64.
14. Sabchareon A, Lang J, Attanath P, et al. A new vero cell rabies vaccine: results of a comparative trial with human diploid cell rabies vaccine in children. Clin Infect Dis 1999; 29:141-149.
15. Lang J, Cetre JC, Picot N, et al. Immunogenicity and safety in adults of a new chromatographically purified vero-cell rabies vaccine (CPRV): a randomized, double-blind trial with purified vero-cell rabies vaccine (PVRV). Biologicals 1998; 26:299-308.
16. Quiambao BP, Lang J, Vital S, et al. Immunogenicity and effectiveness of post-exposure rabies prophylaxis with a new chromatographically purified vero-cell rabies vaccine (CPRV): a two-stage randomized clinical trial in the Philippines. Acta Trop 2000; 75:39-52.
17. Jones RL, Froeschle JE, Atmar RL, et al. Immunogenicity, safety and lot consistency in adults of a chromatographically purified Vero-cell rabies vaccine: a randomized, double-blind trial with human diploid cell rabies vaccine, Vaccine 2001; 19:4635-4643.
18. World Health Organization. WHO recommendations on rabies postexposure treatment and the correct technique of intradermal immunization against rabies. Document No. WHO/ZOO 96.6. Geneva: World Health Organization, 1997.
19. Smith JS, Yager PA, Baeer GM. A rapid tissue culture test for determining rabies neutralizing antibodies. WHO Monogr Ser 1973; 23:354-357.
20. Plotkin SA, Rupprecht CE, Koprowski H. Rabies vaccine. In: Plotkin SA, Orenstein WA, eds. Vaccines, 3rd edn. Philadelphia: WB Saunders Company, 1999; 743-766.
21. Schneiweiss F, Uthoff VA. Sample size and postmarketing surveillance. Drug Information J 1985; 19:13-16.
22. Collett D. Modeling binary data, 1st edn. London: Chapman & Hall, 1991:24.