https://scholars.lib.ntu.edu.tw/handle/123456789/535567
標題: | A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine | 作者: | ARISTINE CHENG Fung C.-P. Liu C.-C. Lin Y.-T. Tsai H.-Y. SHAN-CHWEN CHANG Chou A.-H. Chang J.-Y. Jiang R.-H. Hsieh Y.-C. Su I.-J. Chong P.C.S. SZU-MIN HSIEH |
公開日期: | 2013 | 卷: | 31 | 期: | 20 | 起(迄)頁: | 2471-2476 | 來源出版物: | Vaccine | 摘要: | Background: Large-scale outbreaks of enterovirus 71 (EV71) infections have occurred in Asia-Pacific regions. Severe complications include encephalitis and poliomyelitis-like paralysis, cardiopulmonary collapse, and death, necessitating an effective vaccine against EV71. Methods: In this randomized Phase I study, we evaluated the safety and immunogenicity of an inactivated alum-adjuvanted EV71 whole-virus vaccine produced on Vero cell cultures. Sixty healthy volunteers aged 20-60 years received two doses of vaccine, administered 21 days apart. Each dose contained either 5. μg of EV71 antigen with 150. μg of adjuvant (Group A05) or 10. μg of EV71 antigen with 300. μg of adjuvant (Group B10). Serologic analysis was performed at baseline, day 21, and day 42. Results: There were no serious adverse events. Mild injection site pain and myalgia were the most common adverse events with either vaccine formulation. The immunogenicity data showed that 90% of vaccine recipients have a 4-fold or greater increase in neutralization antibody titers (NT) after the first dose, without a further increase in NT after the second dose. The seroconversion rates on day 21 and day 42 were 86.7% and 93.1% respectively, in Group A05, and 92.9% and 96.3%, respectively, in Group B10. Thus, 5. μg and 10. μg of the EV71 vaccine can induce a remarkable immune response in healthy adults after only the first vaccination. Conclusion: The 5. μg and 10. μg adjuvanted EV71 vaccines are generally safe and immunogenic in healthy adults. (ClinicalTrials.gov number, NCT01268787). ? 2013 Elsevier Ltd. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84877072126&doi=10.1016%2fj.vaccine.2013.03.015&partnerID=40&md5=ba10c1e10941908b564f1487b4a8c2cc https://scholars.lib.ntu.edu.tw/handle/123456789/535567 |
ISSN: | 0264-410X | DOI: | 10.1016/j.vaccine.2013.03.015 | SDG/關鍵字: | Enterovirus 71 vaccine; immunoglobulin G; inactivated virus vaccine; neutralizing antibody; unclassified drug; abdominal pain; adult; antibody titer; article; controlled study; creatine kinase blood level; decreased appetite; diarrhea; dizziness; dose response; drug dose comparison; drug formulation; drug safety; Enterovirus 71; fatigue; female; flatulence; human; human experiment; immunogenicity; influenza; injection site pain; male; muscle weakness; myalgia; nausea; normal human; nose obstruction; oropharynx pain; outcome assessment; phase 1 clinical trial; priority journal; randomized controlled trial; rash; seroconversion; side effect; virus neutralization; xerostomia; Adjuvants, Immunologic; Adult; Alum Compounds; Animals; Antibody Formation; Cercopithecus aethiops; Enterovirus; Enterovirus Infections; Female; Healthy Volunteers; Humans; Male; Middle Aged; Vaccination; Vaccines, Inactivated; Vero Cells; Viral Vaccines; Young Adult |
顯示於: | 醫學系 |
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