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Wu J.,Centers for Disease Control and Prevention | Li W.,National Institute for the Control of Pharmaceuticals and Biological Products | Wang H.-Q.,Centers for Disease Control and Prevention | Chen J.-T.,Sinovac Biotech | And 15 more authors.
Journal of Infectious Diseases | Year: 2010

A double-blind, randomized, controlled trial involving 706 adults was conducted to evaluate the immunogenicity and safety of different dosages of whole-virion or split-virion H1N1 influenza vaccines with or without aluminum adjuvant. A rapid and strong immune response was induced at day 14 after the first injection. The seroprotection rates ranged from 72.7% (95% confidence interval [CI], 62.7%-81.1%) for 5-μg wholevirion aluminum formulation to 97.0% (95% CI, 90.9%- 99.7%) for 30-μg split-virion nonaluminum formulation. All formulations were well tolerated. The incidences of mild, moderate, and severe reactions were 71 (10.1%), 15 (2.1%), and 1 (0.1%) of 706 reactions, respectively. The 15-μg split-virion formulation had the best immunogenicity and safety. © 2010 by the Infectious Diseases Society of America.


Liang X.-F.,U.S. Center for Disease Control and Prevention | Wang H.-Q.,U.S. Center for Disease Control and Prevention | Wang J.-Z.,National Institute for the Control of Pharmaceuticals and Biological Products | Fang H.-H.,National Institute for the Control of Pharmaceuticals and Biological Products | And 19 more authors.
The Lancet | Year: 2010

Background: The current influenza pandemic calls for a safe and effective vaccine. We assessed the safety and immunogenicity of eight formulations of 2009 pandemic influenza A H1N1 vaccine produced by ten Chinese manufacturers. Methods: In this multicentre, double-blind, randomised trial, 12 691 people aged 3 years or older were recruited in ten centres in China. In each centre, participants were stratified by age and randomly assigned by a random number table to receive one of several vaccine formulations or placebo. The study assessed eight formulations: split-virion formulation containing 7·5 μg, 15 μg, or 30 μg haemagglutinin per dose, with or without aluminium hydroxide adjuvant, and whole-virion formulation containing 5 μg or 10 μg haemagglutinin per dose, with adjuvant. All formulations were produced from the reassortant strain X-179A (A/California/07/2009-A/PR/8/34). We analysed the safety (adverse events), immunogenicity (geometric mean titre [GMT] of haemagglutination inhibition antibody), and seroprotection (GMT ≥1:40) of the formulations. Analysis was by per protocol. Two sites registered their trial with ClinicalTrials.gov, numbers NCT00956111 and NCT00975572. The other eight studies were registered with the State Food and Drug Administration of China. Findings: 12 691 participants received the first dose on day 0, and 12 348 participants received the second dose on day 21. The seroprotection rate 21 days after the first dose of vaccine ranged from 69·5% (95% CI 65·9-72·8) for the 7·5 μg adjuvant split-virion formulation to 92·8% (91·9-93·6) for the 30 μg non-adjuvant split-virion formulation. The seroprotection rate was 86·5% (796 of 920; 84·1-88·7) in recipients of one dose of the 7·5 μg non-adjuvant split-virion vaccine compared with 9·8% (140 of 1432; 8·3-11·4) in recipients of placebo (p<0·0001). One dose of the 7·5 μg non-adjuvant split-virion vaccine induced seroprotection in 178 of 232 children (aged 3 years to <12 years; 76·7%, 70·7-82·0), 211 of 218 adolescents (12 years to <18 years; 96·8%, 93·5-98·7), 289 of 323 adults (18-60 years; 89·5%, 85·6-92·6), and 118 of 147 adults older than 60 years (80·3%, 72·9-86·4), meeting the European Union's licensure criteria for seroprotection in all age-groups. In children, a second dose of the 7·5 μg formulation increased the seroprotection rate to 97·7% (215 of 220, 94·8-99·3). Adverse reactions were mostly mild or moderate, and self-limited. Severe adverse effects occurred in 69 (0·6%, 0·5-0·8) recipients of vaccine compared with one recipient (0·1%, 0-0·2) of placebo. The most common severe adverse reaction was fever, which occurred in 25 (0·22%; 0·14-0·33) recipients of vaccine after the first dose and four (0·04%; 0·01-0·09) recipients of vaccine after the second dose compared with no recipients of placebo after either dose. Interpretation: One dose of non-adjuvant split-virion vaccine containing 7·5 μg haemagglutinin could be promoted as the formulation of choice against 2009 pandemic influenza A H1N1 for people aged 12 years or older. In children (aged <12 years), two 7·5 μg doses might be needed. Funding: Sinovac Biotech, Hualan Biological Bacterin, China National Biotec Group, Beijing Tiantan Biological Products, Changchun Institute of Biological Products, Changchun Changsheng Life Sciences, Jiangsu Yanshen Biological Technology Stock, Zhejiang Tianyuan Bio-Pharmaceutical, Lanzhou Institute of Biological Products, Shanghai Institute of Biological Products, and Dalian Aleph Biomedical. © 2010 Elsevier Ltd. All rights reserved.


Liao G.,Peking Union Medical College | Li R.,U.S. Center for Disease Control and Prevention | Li C.,National Institute for the Control of Pharmaceuticals and Biological Products | Sun M.,Peking Union Medical College | And 4 more authors.
Journal of Infectious Diseases | Year: 2012

Background. The production of Sabin inactivated poliovirus vaccine (IPV) can reduce biosafety requirements in the posteradication/post-oral poliovirus vaccine (OPV) era. We conducted a phase II, randomized, positive-controlled trial to assess the safety and immunogenicity of Sabin IPV. Methods. The test groups (A, B, and C) received 3 doses of high, middle, and low D antigen (D Ag) of Sabin IPV at ages 2, 3, and 4 months, respectively. Infants in 2 control groups, group D and group E, received 3 doses of trivalent OPV and conventional IPV (cIPV), respectively, on the same schedule as that of groups A, B, and C. Serum samples were collected before and 30 days after the administration of the third dose. Results. In total, 500 infants were randomly assigned to 5 groups, and 449 infants completed the vaccine series. No serious adverse events were associated with vaccinations. After 3 doses, the seroconversion rates in groups A, B, C, D, and E were 100%, 97.8%, 96.6%, 100%, and 90.1%, respectively, for type 1 poliovirus; 97.7%, 95.7%, 78.7%, 100%, and 90.1%, respectively, for type 2; and 98.8%, 98.9%, 93.3%, 100%, and 97.8%, respectively, for type 3. Conclusions. Sabin IPV has good safety characteristics. The seroconversion rates for type 1 poliovirus (most appropriate concentration, 15 D Ag units [DU]), type 2 (32 DU), and type 3 (45 DU) Sabin IPV were similar to those of the OPV and cIPV control groups. Clinical Trials Registration. NCT01056705. © 2011 The Author.


Zhu F.-C.,U.S. Center for Disease Control and Prevention | Zhang J.,Xiamen University | Zhang X.-F.,U.S. Center for Disease Control and Prevention | Zhou C.,National Institute for the Control of Pharmaceuticals and Biological Products | And 19 more authors.
The Lancet | Year: 2010

Background Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial. Methods Healthy adults aged 16-65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 μg of purified recombinant hepatitis E antigen adsorbed to 0·8 mg aluminium hydroxide suspended in 0·5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov, number NCT01014845. Findings 11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86) participants in the vaccine group and 48 663 participants (86) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100·0 (95 CI 72·1-100·0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted. Interpretation HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16-65 years. Funding Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars. © 2010 Elsevier Ltd.


PubMed | CAS Shanghai Institutes for Biological Sciences, U.S. Center for Disease Control and Prevention, Shanghai Institute of Biological Products and National Institute for the Control of Pharmaceuticals and Biological Products
Type: | Journal: Results in immunology | Year: 2013

The aim of this study is to investigate the long-term immunogenicity of inactivated split-virion 2009 pandemic influenza A H1N1 vaccine after a single immunization. We recruited 480 adults, aged 18-60 years, for a placebo-controlled, observer-masked, single-center clinical study. We randomly assigned subjects into four groups: 15g, 30g and 45g of hemagglutinin (HA) dosage groups, and a placebo control group. Finally, 259 subjects completed the entire study. The rates of seroconversion and seroprotection and the geometric mean increase (GMI) fulfilled the criteria of the European Medicines Agency (EMEA) for influenza vaccine for 180 days after vaccination in all three dosage groups. However, the seroprotection rates of all dosage groups were below 70% at day 360 post vaccination, while the seroconversion rates and the GMI continued to meet the licensure criteria at this time point. In conclusion, a single dose of 15g HA vaccine could induce a protective immune response persisting for at least six months in adults. This study could be beneficial for the future development of influenza vaccines conferring long-term immunity.


Wu J.,Beijing Centers for Diseases Control and Prevention | Liu S.-Z.,National Institute for the Control of Pharmaceuticals and Biological Products | Dong S.-S.,Sinovac Biotech | Dong X.-P.,U.S. Center for Disease Control and Prevention | And 14 more authors.
Vaccine | Year: 2010

Objective: Highly pathogenic avian influenza A virus H5N1 has the potential to cause a pandemic. Many prototype pandemic influenza A (H5N1) vaccines had been developed and well evaluated in adults in recent years. However, data in children are limited. Herein we evaluate the safety and immunogenicity of adjuvanted split-virion and whole-virion H5N1 vaccines in children. Methods: An open-labelled phase I trial was conducted in children aged 3-11 years to receive aluminum-adjuvated, split-virion H5N1 vaccine (5-30μg) and in children aged 12-17 years to receive aluminum-adjuvated, whole-virion H5N1 vaccine (5-15μg). Safety of the two formulations was assessed. Then a randomized phase II trial was conducted, in which 141 children aged 3-11 years received the split-virion vaccine (10 or 15μg) and 280 children aged 12-17 years received the split-virion vaccine (10-30μg) or the whole-virion vaccine (5μg). Serum samples were collected for hemagglutination-inhibition (HI) assays. Findings: 5-15μg adjuvated split-virion vaccines were well tolerated in children aged 3-11 years and 5-30μg adjuvated split-virion vaccines and 5μg adjuvated whole-virion vaccine were well tolerated in children aged 12-17 years. Most local and systemic reactions were mild or moderate. Before vaccination, all participants were immunologically naïve to H5N1 virus. Immune responses were induced after the first dose and significantly boosted after the second dose. In 3-11 years children, the 10 and 15μg split-virion vaccine induced similar responses with 55% seroconversion and seroprotection (HI titer ≥1:40) rates. In 12-17 years children, the 30μg split-virion vaccine induced the highest immune response with 71% seroconversion and seroprotection rates. The 5μg whole-virion vaccine induced higher response than the 10μg split-virion vaccine did. Interpretation: The aluminum-adjuvanted, split-virion prototype pandemic influenza A (H5N1) vaccine showed good safety and immunogenicity in children and 30μg dose induced immune response complying with European Union licensure criteria. [ClinicalTrials.gov identifiers: NCT00900588 and NCT00900991]. © 2010 Elsevier Ltd.

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