Publication: Immunogenicity and safety of an inactivated pandemic H1N1 vaccine provided by the Thai ministry of public health as a routine public health service
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2012-11-05
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01251562
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2-s2.0-84868098164
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Mahidol University
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Southeast Asian Journal of Tropical Medicine and Public Health. Vol.43, No.3 (2012), 680-686
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Opart Kankawinpong, Chariya Sangsajja, Arjin Cholapand, Weerawat Manosuthi, Varaporn Thientong, Naviya Nuntapanich, Pantip Rompotal, Pilaipan Puthavathana Immunogenicity and safety of an inactivated pandemic H1N1 vaccine provided by the Thai ministry of public health as a routine public health service. Southeast Asian Journal of Tropical Medicine and Public Health. Vol.43, No.3 (2012), 680-686. Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/14541
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Immunogenicity and safety of an inactivated pandemic H1N1 vaccine provided by the Thai ministry of public health as a routine public health service
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A prospective study was conducted among 252 participants to study the immunogenicity of unadjuvanted inactivated H1N1 influenza vaccine, using a hemagglutination inhibition (HAI) assay, conducted on Days 0 and 21 following immunization. Adverse events (AEs) were monitored for by interview. The mean age of participants (±SD) was 45 (±11) years. Seventy percent of participants had no history of major medical problems, 28% had a chronic illness and 2% were pregnant women. The HAI assay geometric mean titer (GMT) was 6.9 on Day 0 and 33.4 on Day 21 (4.8 times, p < 0.001). The proportion of participants who had a HAI assay titers ≥40 was 7% (19/252) on Day 0. Those who had a titer ≥40 and/or a 4-fold rise in their HAI titer on Day 21 was 62% (155/ 252) (p < 0.001). Fifty-six percent (142/252) had a four-fold increase in their HAI assay titer. Of the 19 subjects with a Day 0 HAI assay titer > 40, 10 (53%) had a four-fold increases in their HAI assay titer after vaccination. On multivariate analysis, only "older age" was associated with a lower probability of immune response (OR 0.5; 95%CI 0.3-0.8). No serious systemic AEs were reported. Mild erythema and local reaction on Day 2 were reported in 9% (23 of 252). The antibody response after a single dose of inactivated monovalent H1N1 vaccination in this study was relatively low, especially in the older age group. A booster H1N1 vaccine dose may be needed. The vaccine was safe and well tolerated.