Safety and 6-month immune persistence of inactivated poliovirus vaccine (Sabin strains) simultaneously administrated with other vaccines for primary and booster immunization in Jiangxi Province, China

Article

作者: Li, Xiang ; Wei, Lijuan ; Li, Su ; Xie, Pinxing ; Zheng, Min ; Tuo, Ling ; Chen, Xiaomei ; Wu, Fengyun ; Li, Zhen ; Zhao, Yanwei ; Sun, Jianwen ; Xia, Zhiyong ; Yu, Dan ; Gao, Yongjun ; Guo, Shicheng

OBJECTIVESThis study aims to evaluate the safety of a new inactivated poliomyelitis vaccine (Sabin strains) (sIPV) for large-scale use in primary and booster immunizations, whether simultaneously administered with other vaccines or not and to explore the persistence of all vaccines at approximately six months after vaccination.METHODA total of 3200 infants were recruited into this study, including 2000 infants aged 2-3 months randomly assigned (1:1) into the "sIPV basic" or the "sIPV+DTaP" group for primary immunization of sIPV. Another 1200 children aged 18 months old and above were randomly assigned (2:2:1:1) into the "sIPV booster," "sIPV+HepA-I," "sIPV+MMR", or "sIPV+HepA-L" group for booster immunization of sIPV. Adverse events within 30 days of each vaccination dose in all participants were self-reported by guardians using a WeChat mini-program. Approximately 200 blood samples were collected at 5-7 months after the final vaccination to test for antibodies against poliovirus and other viruses.RESULTS3198 participants in total were included in the safety study, including 1999 infants aged 2-3 months old and 1199 children aged 18-26 months old. For primary immunization, the incidence of adverse reactions in the "sIPV basic" and the "sIPV+DTaP" group were 3.19 and 6.21% (P = 0.001), respectively. For booster immunization, the incidences of adverse reaction for the "sIPV booster" group were 2.25%, while the incidence for the "sIPV +others" group in total was 2.50% (P = 0.788). Most adverse reactions were mild. Fever was the most common symptom in all groups. No vaccine-related serious adverse events (SAEs) were observed in this study. The seropositivity rates of antibodies in the "sIPV basic" and the "sIPV+DTaP" group were 92.31 and 100% against type 1 poliovirus (P = 0.031); 96.15% and 98.57% against type 2 poliovirus (P = 0.575); 98.08% and 91.43% against type 3 poliovirus (P = 0.237), respectively. Regarding booster vaccination with sIPV, whether co-administered with other vaccines or not, the seropositivity rates of antibodies against the three types of polioviruses were all 100%. Seropositivity rates of antibodies against hepatitis A, measles, mumps, and rubella were all no <77%, except for pertussis, which was <30%.CONCLUSIONsIPV demonstrated good safety and immune persistence for primary and booster vaccinations, whether administered singly or simultaneously. Antibodies against hepatitis A, measles, mumps and rubella were not disrupted by the co-vaccination. However, the seropositivity rates and geometric mean concentrations (GMCs) of antibodies against pertussis indicate the necessity for a booster dose.

2024-08-01·The Lancet Global Health

Safety and effectiveness of a recombinant hepatitis E vaccine in women of childbearing age in rural Bangladesh: a phase 4, double-blind, cluster-randomised, controlled trial

Article

作者: Stene-Johansen, Kathrine ; Zaman, Khalequ ; Øverbø, Joakim ; Clemens, John D ; Qadri, Firdausi ; Aziz, Asma Binte ; Rahman, Mustafizur ; Laake, Ida ; Yunus, Md ; Khanam, Mahbuba ; Haque, Warda ; Sandbu, Synne ; Gurley, Emily S ; Bhuiyan, Taufiqur R ; Dembinski, Jennifer L ; Dudman, Susanne ; Julin, Cathinka Halle

BACKGROUNDHepatitis E virus (HEV) leads to high mortality in pregnant women in low-income countries. We aimed to evaluate the safety of a HEV vaccine and its effectiveness in preventing hepatitis E during pregnancy.METHODSIn this phase 4, double-blind, cluster-randomised trial, 67 villages in Matlab, Bangladesh, were randomised 1:1 to receive HEV239 (a recombinant HEV vaccine) or a control vaccine (Hepa-B, a hepatitis B vaccine), using block randomisation with random number tables and blocks of size eight, stratified by cluster population size. Eligible non-pregnant women (aged 16-39 years) were vaccinated intramuscularly on day 0, at 1 month, and at 6 months, and followed up for 2 years after the last immunisation. The primary endpoint was hepatitis E in the pregnant, per-protocol population (those who received all three doses within 2 days of the scheduled dates), while safety was a secondary endpoint, assessed in the intention-to-treat (ITT) population (participants who received at least one dose). Solicited adverse events were recorded for the first 7 days after each dose, and unsolicited events until 2 years after a participant's final dose. Pregnancy-related safety outcomes were assessed in the pregnant ITT population. This study is registered with ClinicalTrials.gov (NCT02759991).FINDINGSBetween Oct 2, 2017, and Feb 28, 2019, 19 460 participants were enrolled and received either HEV239 (9478 [48·7%] participants, 33 clusters) or Hepa-B (9982 [51·3%] participants, 34 clusters), of whom 17 937 (92·2%) participants received three doses and 17 613 (90·5%) were vaccinated according to protocol (8524 [48·4%] in the HEV239 group and 9089 [51·6%] in the control group). No pregnant participants were confirmed to have hepatitis E in either treatment group. HEV239 showed a mild safety profile, similar to Hepa-B, with no difference in the proportion of solicited adverse events between groups and no severe solicited events. Pain was the most common local symptom (1215 [12·8%] HEV239 recipients and 1218 [12·2%] Hepa-B recipients) and fever the most common systemic symptom (141 [1·5%] HEV239 recipients and 145 [1·5%] Hepa-B recipients). None of the serious adverse events or deaths were vaccine related. Among pregnant participants, the HEV239 group had a higher risk of miscarriage (136 [5·7%] of 2407 pregnant participants) compared with the control group (102 [3·9%] of 2604; adjusted odds ratio 1·54 [95% CI 1·15-2·08]).INTERPRETATIONThe effectiveness of HEV239 in pregnant women remains uncertain. HEV239 was safe and well tolerated in non-pregnant women, but findings regarding miscarriage warrant further investigation.FUNDINGResearch Council of Norway; Innovax.

2024-03-11·Human Vaccines & Immunotherapeutics3区 · 医学

Vaccination rates and determinants of nine recommended vaccines among migrants in China: a nationwide cross-sectional study

3区 · 医学

Article

作者: Che, Yue ; Wang, Jun ; Bai, Yang ; Wang, Xueyao ; Zhu, Jingmin ; Liu, Jue

In the past 70 years, in order to strengthen disease prevention and improve people's health, China had introduced a series of vaccine policies. However, compared with the permanent population, studies on the vaccination situation of the migrants were lacking. This study aimed to evaluate the vaccination rates of nine recommended vaccines (HepB, HepA, FIn, DTaP, JE, Rab, MPSV, HF, and TIG vaccine) among migrants and related determinants. We used nationwide data from the 2017 Migrant Population Dynamic Monitoring Survey (MDMS) to analyze the vaccination rates of migrants in terms of gender, age, marital status, household registration, education, health level, etc. The total vaccination rate of nine recommended vaccines was 64.8% (6488/10013). Education level and health level were positively correlated with vaccination rates, but age was negatively correlated with vaccination rates. Migrants from urban regions had a higher vaccination rate than those from rural regions. Among the nine recommended vaccines, HepB vaccination rate was the highest (59.08%), while HF vaccination rate was the lowest (4.08%). Combined with policies and demographic characteristics, the relationship between age, household registration, health level, education level and vaccination were studied. The findings suggested that more attention should be given to vaccination of migrants, and the monitoring of vaccination of such groups should be strengthened through information technology.

100 项与 Hepa-B(Incepta Vaccine Ltd.) 相关的药物交易

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