High immunogenicity of measles AIK-C vaccine produced in Vietnam

Abstract

Abstract. The goal of measles elimination has been set for 2012 in the WHO Western Pacific Region. To achieve this goal, an enhanced immunization strategy is required, and measles vaccines have been provided through the Expanded Programme on Immunization (EPI) in Vietnam. A large quantity of vaccines should be supplied for a two-dose immunization schedule with a supplementary catch-up campaign. The live measles vaccine AIK-C strain was produced in Vietnam through technical transfer from the Kitasato Institute, Japan. PolyVac I was produced from bulk materials imported from Japan and PolyVac II from the AIK-C seed. Two clinical trials were conducted using three vaccines: PolyVac I, and II, and the EPI vaccine (Rouvax) for the control. A total of 160 subjects were examined for the immunogenicity of PolyVac I and 57 for that of the EPI vaccine. All subjects became sero-converted in PolyVac I groups for three different Lots, but 54 (94.7%; 88.9-100%) of 57 recipients of the EPI vaccine became sero-positive. For PolyVac II, 118 initially sero-negatives became sero-converted. Whereas, 107 (95.5%; 91.7-99.3%) of 112 initially sero-negatives in the EPI group showed sero-conversion. The mean titers of post-immunization sera of sero-converted subjects receiving PolyVac I and II were lower than that for the EPI vaccine. No significant difference was observed in the incidence of adverse clinical events. Essentially the same results were obtained using PolyVac I and II, showing higher sero-conversion rates than the EPI vaccine, and PolyVac measles AIK-C will be favorable in Vietnam and Southeast Asian countries.

Key words: live attenuated measles vaccine, clinical trial, technical transfer

Keywords

• live attenuated measles vaccine, clinical trial, technical transfer

References

1. WHO-UNICEF joint statement on strategies to reduce measles mortality worldwide. Wkly Epidemiol Rec 2002; 77: 224-228.
2. WHO. Progress in global measles control and mortality reduction, 2000-2006. Wkly Epidemiol Rec 2007; 82: 418-424.
3. WHO. Progress in global measles control and mortality reduction, 2000-2007. Wkly Epidemiol Rec 2008; 83: 441-448.
4. Rota JS, Rota PA, Redd SB, et al. Genetic analysis of measles viruses isolated in the United States, 1995-1996. J Infect Dis 1998; 177: 204-208.
5. Rota PA, Liffick SL, Rota JS, et al. Molecular epidemiology of measles viruses in the United States, 1997-2001. Emerg Infect Dis 2002; 8: 902- 908.
6. Meissner HC, Strebel PM, Orenstein WA. Measles vaccines and the potential for worldwide eradication of measles. Pediatrics 2004; 114: 1065-1069.
7. CDC. Multistate measles outbreak associated with an international youth sporting event--Pennsylvania, Michigan, and Texas, August-September 2007. MMWR Morb Mortal Wkly Rep 2008; 57: 169-173.
8. CDC. Outbreak of measles--San Diego, California, January-February 2008. MMWR Morb Mortal Wkly Rep 2008; 57: 203-206.

9. WHO. Progress in reducing global measles deaths: 1999-2004. Wkly Epidemiol Rec 2006; 81: 90-94.
10. Makino S, Sasaki K, Nakamura N, Nakagawa M, Nakajima S. Studies on the modification of the live AIK measles vaccine. II. Development and evaluation of the live AIK-C measles vaccine. Kitasato Arch Exp Med 1974; 47: 13-21.
11. Makino S. Development and characteristics of live AIK-C measles virus vaccine: a brief report. Rev Infect Dis 1983; 5: 504-505.
12. Sasaki K. Studies on the modification of the live AIK measles vaccine. I. adaptation of the further attenuated AIK measles virus (the strain AIK-L33) to chick embryo cells. The kitasato Arch Exp Med 1974; 47: 1-12.
13. Tidjani O, Grunitsky B, Guérin N, et al. Serological effects of Edmonston-Zagreb, Schwarz, and AIK-C measles vaccine strains given at ages 4-5 or 8-10 months. Lancet 1989; 2: 1357-1360.
14. Bolotovski VM, Grabowsky M, Clements CJ, et al. Immunization of 6 and 9 month old infants with AIK-C, Edmonston-Zagrab, Leningrad-16 and Schwarz strains of measles vaccine. Int J Epidemiol 1994; 23: 1069-1077.
15. Nkrumah FK, Osei-Kwasi M, Dunyo SK, Koram KA, Afari EA. Comparison of AIK-C measles vaccine in infants at 6 months with Schwarz vaccine at 9 months: a randomized controlled trial in Ghana. Bull. World Health Organ 1998; 76: 353-359.
16. Tsai HY, Huang LM, Shih YT, et al. Immunogenicity and safety of standard-titer AIK-C measles vaccine in nine-month-old infants. Viral Immunol 1999; 12: 343-348.
17. Nakayama T, Onoda K. Vaccine adverse events reported in post marketing study of the Kitassato Institute from 1994 to 2004. Vaccine 2007; 25: 570- 576.
18. Fujino M, Yoshida N, Kimura K, et al. Development of a new neutralization test for measles virus. J Virol Method 2007; 142: 15-20.
19. WHO. Measles vaccines. WHO position paper. Wkly Epidemiol Rec 2009; 84: 349-360.
20. Nakayama T, Komase K, Uzuka R, Hoshi A, Okafuji T. Leucine at position 278 of the AIK-C measles virus vaccine strain fusion protein is responsible for reduced syncytium formation. J Gen Virol 2001; 82: 2143-2150.
21. Komase K, Nakayama T, IijimaM, et al. The phosphoprotein of attenuated measles AIK-C vaccine strain contributes to its temperature- sensitive phenotype. Vaccine 2006; 24: 826-834.
22. Nakayama T, Urano T, Osano M, et al. Evaluation of live trivalent vaccine of measles AIK-C strain, mumps Hoshino strain and rubella Takahashi strain, by virus-specific interferon-gamma production and antibody response. Microbiol Immunol 1990; 34: 497-508.
23. Pabst HF, Spady DW, Carson MM, et al. Cell- mediated and antibody immune responses to AIK-C and Connaught monovalent measles vaccine given to 6 month old infants. Vaccine 1999; 17: 1910- 1918.
24. Nakayama T, Aizawa C, Kuno-Sakai H. A clinical analysis of gelatin allergy and determination of its causal relationship to the previous administration of gelatin-containing acellular pertussis vaccine combined with diphtheria and tetanus toxoids. J Allergy Clin Immunol 1999; 103: 321-325.
25. Sakaguchi M, Ogura H, Inouye S. IgE antibody to gelatin in children with immediate-type reactions to measles and mumps vaccines. J AllergyClin Immunol 1995; 96: 563-565.
26. Kelso JM, Jones RT, Yunginger JW. Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gelatin. J Allergy Clin Immunol 1993; 91: 867-872.
27. Nakayama T, Aizawa C. Change in gelatin content of vaccines associated with reduction in reports of allergic reactions. J Allergy Clin Immunol 2000; 106: 591-592.
28. Pool V, Braum MM, Kelso JM, et al. Prevalence of anti-gelatin IgE antibodies in people with anaphylaxis after measles-mumps-rubella vaccine in the United States. Pediatrics 2002; 110: 171.