In July 2015-November 2016, a phase II/III randomized, observer-blind,controlled study of two acellular Pertussis vaccines (aP standalone and TdaP combined vaccines) manufactured by BioNet-Asia Co., Ltd. (Bionet) and chemically-detoxified Adacel Tdap vaccine was conducted in Bangkok, Thailand in healthy participants aged 12-17 years (Protocol No. TDA202; http://clinicaltrials.in.th;Study ID:TCTR20150703002). A total of 450 participants were enrolled into the study at 2 study sites (Site No.1:Faculty of Medicine Siriraj Hospital; Site No.2:Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University) with equal number of 225 participants enrolled at each study site. During the study, the participants had been randomized in a 1:1:1 ratio to received intramuscularly a booster dose (0.5 mL) of the study vaccines.
This is further follow-up from TDA202 clinical trial, which was completed on 29 November 2016. Target population for this study is the group of participants who had received one dose of one of the three study vaccines in the TDA202 trial at site VTC and who had completed the study follow-up at 1-year after vaccination (223 subjects).
In this current study, the long-term persistence of pertussis antibodies induced by a booster dose of recombinant acellular Pertussis based vaccines (Pertagen and Boostagen) manufactured by Bionet will be evaluated and compared to the conventional chemically-inactivated Tdap vaccine (Adacel) at 5 years after previously immunized in the TDA202 study.

开始日期2020-08-24

申办/合作机构

Mahidol University

[+1]

TCTR20190927006 / Completed临床3期IIT

A phase III randomized, observer-blind, active-controlled study to compare the safety and immunogenicity of an investigational combined Tetanus-diphtheria-recombinant acellular pertussis vaccine (BioNet Tdap) and licensed recombinant TdaP vaccine (Boostagen), investigational recombinant monovalent acellular pertussis vaccine (BioNet ap) and licensed recombinant aP vaccine (Pertagen), and another licensed Tdap vaccine, when administered to healthy adults aged of 18-75 years old

开始日期2020-02-10

申办/合作机构

University of Chulalongkorn

NCT04102137 / CompletedN/AIIT

Antibody Persistence at 3 Years After a Single Dose Vaccination of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin

In July 2015-November 2016, a phase II/III randomized, observer-blind,controlled study of two acellular Pertussis vaccines (aP standalone and TdaP combined vaccined) manufactured by BioNet-Asia Co., Ltd. (Bionet) and chemically-detoxified Adacel Tdap vaccine was conducted in Bangkok, Thailand in healthy subjects aged 12-17 years (Protocol No. TDA202; http://clinicaltrials.in.th;Study ID:TCTR20150703002). A total of 450 subjects were enrolled into the study at 2 study sites (Site No.1:Faculty of Medicine Siriraj Hospital; Site No.2:Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University) with equal number of 225 subjects enrolled at each study site. During the study, the subjects had been randomized in a 1:1:1 ratio to received intramuscularly a booster dose (0.5 mL) of the study vaccines.
This is further follow-up from TDA202 clinical trial, which was completed on 29 November 2016. Target population for this study is the group of subjects who had received one dose of one of the three study vaccines in the TDA202 trial at site VTC and who had completed the study follow-up at 1-year after vaccination (223 subjects).
In this current study, the long-term persistence of pertussis antibodies induced by a booster dose of recombinant acellular Pertussis based vaccines (Pertagen and Boostagen) manufactured by Bionet will be evaluated and compared to the conventional chemically-detoxified Tdap vaccine (Adacel) at 3 years after previously immunized in the TDA202 study.

开始日期2018-06-26

申办/合作机构

Mahidol University

100 项与 Recombinant acellular pertussis vaccine(Mahidol University) 相关的临床结果

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100 项与 Recombinant acellular pertussis vaccine(Mahidol University) 相关的转化医学

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100 项与 Recombinant acellular pertussis vaccine(Mahidol University) 相关的专利（医药）

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289

项与 Recombinant acellular pertussis vaccine(Mahidol University) 相关的文献（医药）

2024-07-01·International Journal of Infectious Diseases

Transplacental transfer of maternal antibodies following immunization with recombinant pertussis vaccines during pregnancy: Real-world evidence

Article

作者: Poredi, Indrajeet Kumar ; Yuwaree, Vilasinee ; Chaithongwongwatthana, Surasith ; Pham, Hong Thai ; Kerdsomboon, Chawanee ; Wanlapakorn, Nasamon ; Fortuna, Librada ; Poovorawan, Yong ; Mansouri, Souad ; Wijagkanalan, Wassana

AIM/OBJECTIVEThis study investigates placental antibody transfer following recombinant pertussis vaccination in pregnancy in a real-world setting.METHODSThis postmarketing observational study recruited pregnant women vaccinated with monovalent recombinant acellular pertussis (aP) vaccine (aP_gen; n = 199) or combined to tetanus-diphtheria (TdaP_gen; n = 200), or Td-vaccine only (n = 54). Pregnancy, delivery, and neonatal outcomes were assessed. Cord blood was collected postdelivery and pertussis toxin (PT)-IgG, filamentous hemagglutinin (FHA)-IgG, and PT-neutralizing antibodies (PT-Nab) were assessed.RESULTSNo adverse pregnancy, delivery, or neonatal outcomes attributed to aP_gen_, TdaP_gen, or Td vaccination were reported. High anti-PT antibody levels were detected in cord samples from women vaccinated with aP_gen (geometric mean concentration [GMC] PT-IgG 206.1 IU/ml, 95% confidence intervals [CI]: 164.3-258.6; geometric mean titer [GMT] PT-Nab 105.3 IU/ml, 95% CI: 81.7-135.8) or TdaP_gen (GMC PT-IgG 153.1 IU/ml, 95% CI: 129.1-181.5; GMT PT-Nab 81.5 IU/ml, 95% CI: 66.4-100.0). In the Td-only group, anti-PT antibodies were low (GMC PT-IgG 6.5 IU/ml, 95% CI: 4.9-8.8; GMT PT-Nab 3.8 IU/ml, 95% CI: 2.8-5.1). The same was found for FHA-IgG. Recombinant pertussis vaccination at <27 or 27-36 weeks gestation induced similar cord pertussis antibody levels.CONCLUSIONThis first real-world study confirms that recombinant pertussis vaccination in the second or third trimester of pregnancy results in high levels of passive immunity in infants. Thai Clinical Trial Registry: TCTR20200528006.

2024-03-12·Infection and Immunity

BECC438b TLR4 agonist supports unique immune response profiles from nasal and muscular DTaP pertussis vaccines in murine challenge models

Article

作者: Lee, Katherine ; Pyles, Gage M. ; Barbier, Mariette ; Petty, Jonathan E. ; Hall, Jesse M. ; Bevere, Justin R. ; Damron, F. Heath ; Fitzgerald, Nicholas A. ; Bitzer, Graham J. ; Ernst, Robert K. ; Wolf, M. Allison ; Huckaby, Annalisa B. ; DeJong, Megan A.

ABSTRACT The protection afforded by acellular pertussis vaccines wanes over time, and there is a need to develop improved vaccine formulations. Options to improve the vaccines involve the utilization of different adjuvants and administration via different routes. While intramuscular (IM) vaccination provides a robust systemic immune response, intranasal (IN) vaccination theoretically induces a localized immune response within the nasal cavity. In the case of a Bordetella pertussis infection, IN vaccination results in an immune response that is similar to natural infection, which provides the longest duration of protection. Current acellular formulations utilize an alum adjuvant, and antibody levels wane over time. To overcome the current limitations with the acellular vaccine, we incorporated a novel TLR4 agonist, BECC438b, into both IM and IN acellular formulations to determine its ability to protect against infection in a murine airway challenge model. Following immunization and challenge, we observed that DTaP + BECC438b reduced bacterial burden within the lung and trachea for both administration routes when compared with mock-vaccinated and challenged (MVC) mice. Interestingly, IN administration of DTaP + BECC438b induced a Th1-polarized immune response, while IM vaccination polarized toward a Th2 immune response. RNA sequencing analysis of the lung demonstrated that DTaP + BECC438b activates biological pathways similar to natural infection. Additionally, IN administration of DTaP + BECC438b activated the expression of genes involved in a multitude of pathways associated with the immune system. Overall, these data suggest that BECC438b adjuvant and the IN vaccination route can impact efficacy and responses of pertussis vaccines in pre-clinical mouse models.

2024-01-01·Vaccine

Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines

Article

作者: Mansouri, Souad ; Tang, Yuxiao ; Bhat, Niranjan ; Holt, Renee ; Andi-Lolo, Indah ; Fortuna, Librada ; Rungmaitree, Supattra ; Kerdsomboon, Chawanee ; Anuwutnavin, Sanitra ; Chaithongwongwatthana, Surasith ; Puthanakit, Thanyawee ; Anugulruengkitt, Suvaporn ; Lapphra, Keswadee ; Chayachinda, Chenchit ; Yuwaree, Vilasinee ; Thai, Pham Hong ; Innis, Bruce L ; Chokephaibulkit, Kulkanya ; Tawan, Monta

INTRODUCTIONRecombinant acellular pertussis (ap) vaccines containing genetically inactivated pertussis toxin (PT_gen) and filamentous hemagglutinin (FHA) with or without tetanus (TT) and diphtheria (DT) vaccines (Td) were found safe and immunogenic in non-pregnant and pregnant women. We report here maternal antibody transfer and safety data in mothers and neonates.METHODSThis is the follow up of a phase 2 trial in 2019 among 400 pregnant women who randomly received one dose of recombinant pertussis-only vaccine containing 1 µg PT_gen and 1 µg FHA (ap1_gen), or Td combined with ap1_gen (Tdap1_gen), or with 2 µg PT_gen and 5 µg FHA (Tdap2_gen), or with 5 µg PT_gen and 5 µg FHA (TdaP5_gen, Boostagen®, BioNet, Thailand) or chemically-inactivated acellular pertussis comparator (Tdap8_chem, Boostrix™, GSK, Belgium), either in the second or third trimester of gestation. IgG against PT, FHA, TT and DT were assessed by ELISA, PT-neutralizing antibodies (PTNA) by Chinese Hamster Ovary cell assay and safety outcomes at delivery in mothers and at birth.RESULTSAnti-PT and anti-FHA geometric mean concentration (GMC) ratio between infants at birth and mothers at delivery was above 1 in all groups. PT GMC in infants at birth were ≥30 IU/mL in all groups with the highest titers in infants found in TdaP5_gen group at birth (118.8 [95% CI 93.9-150.4]). At 2 months, PT GMC ratio to Tdap8_chem (98.75% CI) was significantly higher for TdaP5_gen (2.6 [1.7-4.0]) and comparable for other recombinant vaccines. No difference in PTNA titers at birth was observed between all groups nor between time of vaccination. Adverse events were comparable in all vaccine groups.CONCLUSIONSBioNet licensed (TdaP5_gen and Tdap2_gen) and candidate vaccines (Tdap1_gen and ap1_gen) when given to pregnant women in the second or third trimester of gestation are safe and have induced passive pertussis immunity to infants.

100 项与 Recombinant acellular pertussis vaccine(Mahidol University) 相关的药物交易

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