PMID- 29087761
OWN - NLM
STAT- MEDLINE
DCOM- 20190102
LR  - 20190102
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 14
IP  - 3
DP  - 2018 Mar 4
TI  - The safety of influenza vaccine in clinically cured leprosy patients in China.
PG  - 671-677
LID - 10.1080/21645515.2017.1390638 [doi]
AB  - BACKGROUND: Leprosy is an infectious disease caused by the bacterium 
      Mycobacterium leprae. Influenza vaccine is an important influenza prevention 
      strategy and the preparations used display good safety and tolerability profiles. 
      But the safety of applying influenza vaccine on the clinical cured leprosy 
      patients is unclear. METHODS: We conducted an observational clinical study, in 
      Wuhan between November 15, 2016 and March 1, 2017. Two groups of participants 
      >/=50 years of age received a 0.5 ml dose of the inactivated split-virion trivalent 
      influenza vaccine and a follow-up 28 days observation of any solicited and 
      unsolicited adverse events. RESULTS: A total of 134 subjects were included in the 
      study. The total rate of reactogenicity was 5.4% [2/37] in leprosy group and 
      15.5% [15/ 97] in control group, the difference of reactogenicity between two 
      groups was not significant (p = 0.1522). For solicited injection-sites adverse 
      events (AEs), 12.4% [12/ 97] participants in the control group reported of 
      itching, pain, erythema, swelling or induration, and no participants in leprosy 
      group reported of any solicited injection-sites AEs. For solicited systemic AEs, 
      7.2% [7 / 97] participants in the control group reported of fever, malaise or 
      headache, and 2.7% [1 / 37] participants in the leprosy group reported of fever, 
      statistic result showed that the difference was not significant (p = 0.4438). 
      Unsolicited AEs was reported by one male aged 76, 4 hours after vaccination 
      administration, his plantar ulcer area began bleeding. All AEs were grade 1 or 
      grade 2, and no recurrence of lepra reaction, AEs leading to early withdrawal 
      from the study, or deaths were reported in this study. CONCLUSIONS: To our 
      knowledge, the present study is the first clinical study to evaluate the safety 
      of influenza vaccine in clinically cured leprosy patients. We concluded that 
      clinically cured leprosy patients are relatively safe for influenza vaccine. More 
      importantly, our study make a positive and scientific efforts to 
      eradicate discrimination on leprosy. In our study, we described a patient with 
      plantar ulcer undergoing bleeding for 4 hours after vaccine administration. Based 
      on evidence we have, we interpret that this adverse event may probably associated 
      with vaccine, and patients with ulcer and leprosy need intensive attention after 
      vaccines administration.
FAU - Zheng, Yi
AU  - Zheng Y
AD  - a Department of Leprosy , Wuhan Institute of Dermatology and Venereology , Wuhan 
      , China.
FAU - Chen, Li
AU  - Chen L
AD  - b Department of Immunization , Jianghan Center for Disease Prevention and Control 
      , Wuhan , China.
FAU - Zou, Jie
AU  - Zou J
AD  - a Department of Leprosy , Wuhan Institute of Dermatology and Venereology , Wuhan 
      , China.
FAU - Zhu, Zheng-Gang
AU  - Zhu ZG
AD  - c Department of Immunization , Wuhan Center for Disease Prevention and Control , 
      Wuhan , China.
FAU - Zhu, Li
AU  - Zhu L
AD  - a Department of Leprosy , Wuhan Institute of Dermatology and Venereology , Wuhan 
      , China.
FAU - Wan, Jing
AU  - Wan J
AD  - a Department of Leprosy , Wuhan Institute of Dermatology and Venereology , Wuhan 
      , China.
FAU - Hu, Quan
AU  - Hu Q
AD  - a Department of Leprosy , Wuhan Institute of Dermatology and Venereology , Wuhan 
      , China.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Observational Study
DEP - 20171214
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Viral/immunology
MH  - China
MH  - Female
MH  - Hemagglutination Inhibition Tests/methods
MH  - Humans
MH  - Influenza Vaccines/*adverse effects/*immunology
MH  - Influenza, Human/*immunology/*prevention & control
MH  - Leprosy/*immunology/virology
MH  - Male
MH  - Middle Aged
MH  - Vaccination/methods
MH  - Vaccines, Inactivated/adverse effects/immunology
PMC - PMC5861811
OTO - NOTNLM
OT  - Influenza Vaccine
OT  - Leprosy
OT  - Reactogenicity
OT  - Safety
OT  - Ulcer
EDAT- 2017/11/01 06:00
MHDA- 2019/01/03 06:00
PMCR- 2017/12/14
CRDT- 2017/11/01 06:00
PHST- 2017/11/01 06:00 [pubmed]
PHST- 2019/01/03 06:00 [medline]
PHST- 2017/11/01 06:00 [entrez]
PHST- 2017/12/14 00:00 [pmc-release]
AID - 1390638 [pii]
AID - 10.1080/21645515.2017.1390638 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2018 Mar 4;14(3):671-677. doi: 
      10.1080/21645515.2017.1390638. Epub 2017 Dec 14.