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IMMUNOGENICITY OF A LOCALLY PRODUCED HEPATITIS B VACCINE WITH THE BIRTH DOSE STORED OUTSIDE THE COLD CHAIN IN RURAL VIETNAM

The heat stability of hepatitis B vaccine (HepB vaccine) should enable its storage outside the cold chain (OCC), increasing access to the birth dose in areas lacking refrigeration. We compared the immunogenicity of a locally produced vaccine among infants who received three doses stored within the cold chain (n = 358) or for whom the first dose was stored OCC for up to one month (n = 748). Serum was collected from these infants at age 9–18 months. The vaccine was protective in 80.3% of all infants. There were no differences in the prevalence of a protective level of antibody or antibody titer among groups of infants according to storage strategy. Differences in antibody titer between certain groups of infants could be explained by different vaccination schedules. Where birth dose coverage will be improved, HepB vaccine can be taken OCC for up to one month without affecting its immunogenicity.

Received April 26, 2005. Accepted for publication September 9, 2005.

Acknowledgments: We gratefully acknowledge the support of the scientists and administrative staff at the National Institute of Hygiene and Epidemiology in Hanoi, the staff of the District and Commune Health Services in Quang Xuong and Ngoc Lac, Mirella Ozols (University of Melbourne), and the families of infants who participated in the study.

Financial support: This study was supported by the Australian Agency for International Development as part of the broader primary health care project "Strengthening Immunization and Malaria Control in Vietnam."

^* Address correspondence to Beverley-Ann Biggs, Department of Medicine (Royal Melbourne Hospital/Western Hospital), University of Melbourne, Royal Melbourne Hospital, Parkville 3050, Australia. E-mail: babiggs{at}unimelb.edu.au

Authors’ addresses: David B. Hipgrave, United Nations Children’s Fund Indonesia, Wisma Metropolitan II, Jalan Jend. Sudirman, Kav. 31, Jakarta 12920, Indonesia. Trung Nam Tran, Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Box 281, SE 171 77, Stockholm, Sweden, E-mail: dhipgrave{at}unicef.org. Vu Minh Huong and James E. Maynard, Program for Appropriate Technology in Health, Box 252, International Post Office, Hanoi, Vietnam. Do Tuan Dat, Nguyen Tuyet Nga, Hoang Thuy Long, and Nguyen Thu Van, National Institute of Hygiene and Epidemiology, 1 Yersin Street, Hanoi 10000, Vietnam. Beverley-Ann Biggs, Department of Medicine (Royal Melbourne Hospital/Western Hospital), University of Melbourne, Royal Melbourne Hospital, Parkville 3050, Australia, Telephone: 61-3-8344-3257, Fax: 61-3-9347-1863, E-mail: babiggs{at}unimelb.edu.au.

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