A clinical study to assess the immunogenicity and safety of a monovalent 2009 influenza A (H1N1) vaccine in an area with low-level epidemics of pandemic influenza

Kung, Hsiang Chi; Huang, Kuo Chin; Kao, Tsui Mai; Lee, Yi Chien; Chang, Feng Yee; Wang, Ning Chi; Liu, Yung Ching; Lee, Wen Sen; Liu, Hsing Jin; Chen, Chin I.; Chen, Chien Hui; Huang, Li Min; Hsieh, Szu‐Min

doi:10.1016/j.vaccine.2010.08.073

Cited by 16 publications

(22 citation statements)

References 12 publications

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“…Several studies have assessed the immunogenicity and safety of various formulations of 2009 H1N1 vaccine, comparing a wide variety of doses with or without different adjuvants [8], [9], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19], [20], [21], [22], [23], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39]. Although no major harms were noted for any of the vaccine formulations, the immunogenicity varied and several issues remain about the relative merits of each formulation that are very difficult to address examining single trials.…”

Section: Introductionmentioning

confidence: 99%

Meta-Analysis of the Immunogenicity and Tolerability of Pandemic Influenza A 2009 (H1N1) Vaccines

et al. 2011

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BackgroundAlthough the 2009 (H1N1) influenza pandemic officially ended in August 2010, the virus will probably circulate in future years. Several types of H1N1 vaccines have been tested including various dosages and adjuvants, and meta-analysis is needed to identify the best formulation.MethodsWe searched MEDLINE, EMBASE, and nine clinical trial registries to April 2011, in any language for randomized clinical trials (RCTs) on healthy children, adolescents, adults and the elderly. Primary outcome was the seroconversion rate according to hemagglutinination-inhibition (HI); secondary outcomes were adverse events. For the primary outcome, we used head-to-head meta-analysis and multiple-treatments meta-analysis.ResultsEighteen RCTs could be included in all primary analyses, for a total of 76 arms (16,725 subjects). After 2 doses, all 2009 H1N1 split/subunit inactivated vaccines were highly immunogenic and overcome CPMP seroconversion criteria. After 1 dose only, all split/subunit vaccines induced a satisfactory immunogenicity (> = 70%) in adults and adolescents, while only some formulations showed acceptable results for children and elderly (non-adjuvanted at high-doses and oil-in-water adjuvanted vaccines). Vaccines with oil-in-water adjuvants were more immunogenic than both nonadjuvanted and aluminum-adjuvanted vaccines at equal doses and their immunogenicity at doses < = 6 µg (even with as little as 1.875 µg of hemagglutinin antigen) was not significantly lower than that achieved after higher doses. Finally, the rate of serious vaccine-related adverse events was low for all 2009 H1N1 vaccines (3 cases, resolved in 10 days, out of 22826 vaccinated subjects). However, mild to moderate adverse reactions were more (and very) frequent for oil-in-water adjuvanted vaccines.ConclusionsSeveral one-dose formulations might be valid for future vaccines, but 2 doses may be needed for children, especially if a low-dose non-adjuvanted vaccine is used. Given that 15 RCTs were sponsored by vaccine manufacturers, future trials sponsored by non-industry agencies and comparing vaccines using different types of adjuvants are needed.

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Section: Introductionmentioning

confidence: 99%

Meta-Analysis of the Immunogenicity and Tolerability of Pandemic Influenza A 2009 (H1N1) Vaccines

et al. 2011

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“…After the second dose, seroprotection increased only to 98.3% (5). Another study also showed that neither 2 doses of 15 g nor 2 doses of 30 g produced greater immunity than a single 15-g dose (14). Likewise, we found that the seroprotection rates with 15 g HA on day 21 were 77.1% in the elderly and 87.8 to 92.7% in adults 3 weeks after vaccination; these rates changed to 72.3% in the elderly and 90.2% in the adults 3 weeks after the second vaccination.…”

Section: Discussionmentioning

confidence: 98%

“…Most studies on the immunogenicity of H1N1 vaccine were conducted 42 days postvaccination (5,14,30). In China, Zhu et al showed that subjects 18 years old or older who received 15 g of nonadjuvant vaccine exhibited seroprotection rates of 79.1 to 97.1% on day 21 after the first dose; rates increased to 93.3 to 97.1% on day 35, 14 days after the second dose (30).…”

Section: Discussionmentioning

confidence: 99%

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Persistence of Immunogenicity of a Monovalent Influenza Virus A/H1N1 2009 Vaccine in Healthy Volunteers

Lai

Yang

Hsieh

et al. 2012

Clin. Vaccine Immunol.

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ABSTRACTAfter WHO declared H1N1 pandemic, global vaccination was carried out immediately after much research. However, the data on long-term immunogenicity were lacking. We aimed to investigate the long-term immunogenicity of different H1N1 vaccine dosage groups 24 weeks after vaccination by a randomized clinical trial. A total of 218 participants were stratified into adult (≤60 years old) and elderly (>60 years old) groups. The adults were randomized in a 1:1:1 ratio. The first group received a single dose of vaccine with 15 μg hemagglutination antigen (HA). The other two groups received two doses with 15 μg or 30 μg HA triweekly. The elderly were randomized 1:1 for two doses of 15 or 30 μg HA. We evaluated serologic responses at prevaccination and weeks 3, 6, and 24. We also examined possible associated factors of immunogenicity by multivariate logistic regression analyses. At week 24, seroprotection (anti-HA antibody level ≥ 1:40) remained at 76.8% and 46.2% in the adult and elderly groups, respectively. The adult group had a higher seroprotection rate (odds ratio of 2.98, 95% confidence interval [CI]: 1.21 to 7.36) than the elderly group. There was no statistical difference in seroprotection and seroconversion rates between different adult and elderly dosage groups. Lower immunogenicity in the elderly than in the adults 24 weeks after the vaccination was observed. However, there was no statistically significant difference among different dose groups. Therefore, we suggest only a single vaccination dose of 15 μg HA for adults and two doses of 15 μg HA for the elderly in the future.

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“…However, the influenza A(H1N1) vaccine is a relatively newly licensed vaccine in China. Although its immunogenicity has been effective (8,16,19,20), there are very few prospective reports addressing the safety of the vaccine in pregnant women in China. Our study indicated that the seroconversion rate in the vaccinated pregnant women was 90.4% (95% CI, 82.6% to 95.5%) and was not significantly different from that in adults 18 to 60 years old in 2 other studies carried out in China (8,21).…”

Section: Discussionmentioning

confidence: 99%

Prospective Cohort Study of the Safety of an Influenza A(H1N1) Vaccine in Pregnant Chinese Women

Ma¹,

Zhang²,

Jiang³

et al. 2014

Clin. Vaccine Immunol.

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To monitor and evaluate the safety of the influenza A(H1N1) vaccine in pregnant women and its influence on the fetus and neonate, we performed a prospective study in which 122 pregnant Chinese women who received the influenza A(H1N1) vaccine and 104 pregnant women who did not receive any vaccine (serving as controls) were observed. The results indicated that the seroconversion rate in the vaccinated group was 90.4% (95% confidence interval [CI], 82.6% to 95.5%). The rate of adverse events following immunization in the pregnant women who received the influenza A(H1N1) vaccine was 3.3%. The spontaneous abortion rates in the vaccinated group and the unvaccinated group were 0.8% and 1.9%, respectively (exact probability test, P ‫؍‬ 0.470), the prolonged-pregnancy rates were 8.2% and 4.8%, respectively ( 2 ‫؍‬ 1.041, P ‫؍‬ 0.308), the low-birth-weight rates were 1.6% and 0.95%, respectively (exact probability test, P ‫؍‬ 1.000), and the spontaneous-labor rates were 70.5% and 75%, respectively ( 2 ‫؍‬ 0.573, P ‫؍‬ 0.449). All newborns who have an Apgar score of >7 are considered healthy; Apgar scores of >9 were observed in 38.5% and 57.7% of newborns in the vaccinated group and the unvaccinated group, respectively ( 2 ‫؍‬ 8.274, P ‫؍‬ 0.004). From these results, we conclude that the influenza A(H1N1) vaccine is safe for pregnant women and has no observed adverse effects on fetal growth. (This study has been registered at ClinicalTrials.gov under registration no. NCT01842997.)

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A clinical study to assess the immunogenicity and safety of a monovalent 2009 influenza A (H1N1) vaccine in an area with low-level epidemics of pandemic influenza

Cited by 16 publications

References 12 publications

Meta-Analysis of the Immunogenicity and Tolerability of Pandemic Influenza A 2009 (H1N1) Vaccines

Meta-Analysis of the Immunogenicity and Tolerability of Pandemic Influenza A 2009 (H1N1) Vaccines

Persistence of Immunogenicity of a Monovalent Influenza Virus A/H1N1 2009 Vaccine in Healthy Volunteers

Prospective Cohort Study of the Safety of an Influenza A(H1N1) Vaccine in Pregnant Chinese Women

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