A PHASE I/II (PILOT) RANDOMIZED SINGLE BLIND TRIAL TO COMPARE THE SAFETY AND IMMUNOGENECITY OF TETRABHAY DTwP-H COMBINATION VACCINE WITH SHANTETRA TM IN HEALTHY CHILDREN

开始日期2010-09-08

申办/合作机构-

ISRCTN95974322 / CompletedN/AIIT

Immunogenicity and safety of Brazilian combined vaccine against diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B (DTPw/HB/hib)

开始日期2008-03-17

申办/合作机构-

100 项与 DTP-Hepatitis B vaccine(PT Bio Farma) 相关的临床结果

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100 项与 DTP-Hepatitis B vaccine(PT Bio Farma) 相关的转化医学

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100 项与 DTP-Hepatitis B vaccine(PT Bio Farma) 相关的专利（医药）

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204

项与 DTP-Hepatitis B vaccine(PT Bio Farma) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Epidemiological characteristics and survival analysis of pertussis in Quzhou

Article

作者: Xu, Wenjie ; Zheng, Canjie ; Yin, Zhiying ; Fang, Quanjun ; Gong, Xiaoying ; Fu, Canya

Despite high vaccination coverage in high-income countries, recent reports of pertussis resurgence have heightened public concern about vaccine effectiveness and vaccination. Quzhou City has gradually transitioned from DTwP to DTaP vaccines, achieving a remarkable vaccination coverage rate of 99%. However, since 2024, there has been a significant surge in pertussis cases in Quzhou City. We collected data on pertussis cases, described the epidemiological characteristics of pertussis outbreaks in Quzhou City, examined pertussis vaccination history, and conducted a COX survival analysis. Pertussis cases reported in Quzhou City from January to April 2024 were far higher than those reported in previous years during the same period. Geographically, cases were concentrated in the central region and predominantly affected children under 9 years old, with a focus on the 5-9 age group. Survival analysis revealed that the risk of pertussis incidence increased by 2.84 times (HR = 2.87, 95% CI = 2.27 ~ 3.63) when comparing self-paid vaccines to free vaccines. The pertussis situation in Quzhou City remains critical, emphasizing the need for enhanced immunization strategies and further optimization of pertussis immunization protocols.

2024-05-01·eClinicalMedicine

Safety and immunogenicity of a single dose of Tdap compared to Td in pregnant women in Mali and 3 its effect on infant immune responses: a single-centre, randomised, double-blind, active-controlled phase 2 study

Article

作者: Powell, Jonathan A ; Hensel, Elizabeth ; Rotrosen, Elizabeth ; Neuzil, Kathleen M ; Portillo, Susana ; Diallo, Fatoumata ; Kotloff, Karen L ; Selamawi, Semhal ; Sow, Samba O ; Williams, Margaret ; Tapia, Milagritos D ; Traoré, Awa ; Haidara, Fadima Cheick ; Pasetti, Marcela F ; Makowski, Mat

BackgroundWhile maternal pertussis vaccination is a strategy to reduce infant morbidity, safety and immunogenicity data are limited in sub-Saharan Africa. We aimed to evaluate the safety of a single dose of tetanus, diphtheria and acellular pertussis vaccine (Tdap) vaccine compared to tetanus and diphtheria vaccine (Td) vaccine in pregnant women in Bamako, Mali and to assess the pertussis toxin (PT) antibody response at birth.MethodsIn this phase 2, single-centre, randomised, double-blind, active-controlled study, from 23 January 2019 to 10 July 2019, healthy 18-39 year old women in the second trimester of a singleton pregnancy were randomised 2:1 to receive Tdap or Td. Blood was tested for serum immunoglobulin G (IgG) against PT and other vaccine antigens using a qualified Meso Scale Discovery multiplex immunoassay. The co-primary objectives evaluated safety and birth anti-PT levels. Infant immune responses to whole-cell pertussis vaccine (DTwP) were assessed. Statistical analysis was descriptive. This trial is registered with clinicaltrials.gov, NCT03589768.Findings133 women received Tdap and 67 received Td, with 126 and 66 livebirths, respectively. In the Tdap group, 22 serious adverse events (SAEs) including one maternal death occurred in 20 participants (15·0%), with 10 SAEs in 10 participants (14·9%) in the Td group. Among infants, 18 events occurred among 13 participants (10.3%) and 8 SAEs in 6 participants (9.1%), including three and two infant deaths, occurred in Tdap and Td groups, respectively. None were related to study vaccines. Anti-PT geometric mean concentration (GMC) at birth in the Tdap group was higher than in the Td group (55.4 [46.2-66.6] IU/ml vs 7.9 [5.4-11.5] IU/ml). One month after the third dose of DTwP, the GMC in infants born to mothers in the Tdap group were lower compared to the Td group (20.2 [13.7-29.9] IU/ml vs 77.2 [32.2-184.8] IU/ml). By 6 months of age, the anti- PT GMCs were 17.3 [12.8-23.4] IU/ml and 67.1 [35.5-126.7] IU/ml in Tdap and Td groups, respectively. At birth, anti-tetanus toxin (TT) GMCs were higher in infants in the Td vs Tdap group (5.9 [5.0-7.0] IU/ml vs 4.1 [3.5-4.8] IU/ml). Anti-diphtheria toxin GMCs were similar in both groups.InterpretationTdap administered to pregnant women in Mali is safe and well-tolerated. Infants of mothers who received Tdap were born with high PT and protective anti-TT antibody levels. By six months of age, after primary vaccination, the PT levels were lower in the Tdap group compared to the Td group. The blunted immune responses to primary DTwP vaccination in the Tdap infant group warrant further study.FundingThis project was funded by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), under contract numbers 75N93021C00012 (The Emmes Company), and HHSN27220130000221 (University of Maryland, Baltimore). Dr. Susana Portillo was supported by NIH award no. T32AI007524. NIAID, NIH provided Tdap vaccine (BOOSTRIX).

2023-12-01·Pediatric Infectious Disease Journal

Antibody Persistence Following Administration of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T and IPV Vaccines and Safety and Immunogenicity of a Booster Dose of DTwP-IPV-HB-PRP~T Administered With an MMR Vaccine in Healthy Infants in India

Article

作者: Palvi, Kudyar ; Kandukuri, Sreeramulu Reddy ; Mitra, Monjori ; Palkar, Sonali ; Mangarule, Somnath ; Leclercq, Julie ; Siddaiah, Prashanth ; Noriega, Fernando ; Singh, Raghvendra ; Shetty, Ranjitha ; Varghese, Kucku ; Kukian, Darshna ; Padmavathi, Inumarthi Vara ; Midde, Venkata Jayanth ; Tripathi, Virendranath ; Kawade, Anand ; Dhati, Ravi Mandyam

Background:Antibody persistence of a whole-cell pertussis-containing hexavalent vaccine (DTwP-IPV-HB-PRP~T) and its co- or sequential administration with measles, mumps, rubella (MMR) vaccine were evaluated.Methods:Phase III, open-label, randomized, multicenter study in India. Healthy toddlers 12–24 months of age who had received DTwP-IPV-HB-PRP~T or separate DTwP-HB-PRP~T+IPV primary vaccination at 6–8, 10–12 and 14–16 weeks of age received a DTwP-IPV-HB-PRP~T booster concomitantly with MMR (N = 336) or 28 days before MMR (N = 340). Participants had received a first dose of measles vaccine. Immunogenicity assessment used validated assays and safety was by parental reports. All analyses were descriptive.Results:All participants had prebooster anti-T ≥0.01 IU/mL and anti-polio 1 and 3 ≥8 1/dil, and ≥96.5% had anti-D ≥0.01 IU/mL, anti-HBs ≥10 mIU/mL, anti-polio 2 ≥8 1/dil and anti-PRP ≥0.15 µg/mL; for pertussis, antibody persistence was similar in each group. Postbooster immunogenicity for DTwP-IPV-HB-PRP~T was similar for each antigen in each group: ≥99.5% of participants had anti-D ≥0.01 IU/mL, anti-T ≥0.01 IU/mL, anti-polio 1, 2 and 3 >8 1/dil, anti-HBs ≥10 mIU/mL and anti-PRP ≥1 µg/mL; for pertussis, vaccine response was similar in each group [72.0%–75.9% (anti-PT), 80.8%–81.4% (anti-FIM), 77.6%–79.5% (anti-PRN), 78.2%–80.8% (anti-FHA)]. There was no difference in MMR immunogenicity between groups, and no difference in DTwP-IPV-HB-PRP~T booster immunogenicity based on the primary series. There were no safety concerns.Conclusions:DTwP-IPV-HB-PRP~T antibody persistence was similar to licensed comparators. Booster immunogenicity was robust after DTwP-IPV-HB-PRP~T with or without MMR, and MMR immunogenicity was not affected by coadministration with DTwP-IPV-HB-PRP~T.Clinical Trials Registry India Number:CTRI/2020/04/024843.

项与 DTP-Hepatitis B vaccine(PT Bio Farma) 相关的新闻（医药）

2024-10-16

·上海市生物医药科技发展中心

VPD医学进展周报131期（2024年9月27-10月11日）

本期概要 WHO-全球脊髓灰质炎病毒最新流行情况 - 截至10月6日 Gavi2023年度进展报告-2023年疫苗接种避免了超130万人死亡 NEJM-减剂量的肺炎球菌结合疫苗 -一项非劣效性试验全液态DTwP-HepB-IPV-Hib 六联疫苗在印度幼儿中的安全性和免疫原性流感疫苗预防一年内急性心血管事件的保护效果 - 基于北京数据单价(LLR)和五价(RV5)轮状病毒疫苗对住院儿童RV感染的效果 PAHO - HPV检测和单剂疫苗是美洲应对宫颈癌的关键婴儿RSV感染预防 - WHO SAGE首次建议孕妇接种疫苗/新生儿使用单抗 PATH- 疫苗成本计算器：为免疫决策提供参考的资源 WHO- HPV疫苗的选择-推荐国产二价疫苗和单剂程序 *如需VPD医学周刊的PDF文件，请邮件至cnvac@ucas.ac.cn，来信请注明机构、职位和姓名点击图片更清晰！来源 | CNVAC

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