A Phase 2 Study to Evaluate the Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults Who Have Received a Previous Booster Dose of an Authorized/Approved COVID-19 Vaccine

This clinical trial is designed to assess the safety, tolerability and immunogenicity of a single dose of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 vaccines as a booster dose, given at least 3 months after receipt of a previous booster dose of any authorized/approved COVID-19 vaccine.

开始日期2023-01-19

申办/合作机构

Technovalia, Pty Ltd

[+3]

NCT05231369 / Recruiting临床1期IIT

A Phase 1 Study to Evaluate Safety, Immunogenicity of the ChulaCov19 BNA159 mRNA Vaccine in Healthy Adults

This is a phase 1 study that will evaluate the safety and immunogenicity of ChulaCov19 BNA159 mRNA vaccine in healthy adults.

开始日期2022-12-14

申办/合作机构

University of Chulalongkorn

[+1]

NCT04589312 / Completed临床2期IIT

The Safety and imMunogeNicity of Combined Pertussis-cOntaining Vaccine (Tdap) for HIV-infected Pregnant WomEn and Their newboRns - A Randomized Clinical Trial

Pertussis is resurging worldwide. In Africa alone it is estimated that there are 2.1 million cases and 542,000 deaths from pertussis in infants under 1 year with the highest rates of morbidity and mortality in infants <3 months old, before possible prevention via the infant immunization programme1. To protect these most vulnerable infants, the World Health Organisation (WHO) recommends Tdap vaccination as safe in pregnancy and recommends the use of wP vaccines within the EPI. Maternal antibody following aP vaccination can interfere with infant anti-pertussis antibody responses post infant EPI vaccination, which is of concern in high burden settings such as Uganda. There are therefore multiple factors in this population which may influence the effect of pertussis immunization in pregnancy, and which have not been studied, most notably HIV infection and interference with wP vaccines in infants. The immunogenicity of Tdap in HIV-infected pregnant women has not yet been examined. In addition, to date, the effect of maternal vaccination, placental transfer and infant antibody responses in HEU infants have not been studied at all. There are no studies examining the immune response to wP vaccine administered to infants (EPI recommendation) whose mothers received aP in pregnancy.

开始日期2020-10-21

申办/合作机构

St. George's University of London

[+4]

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项与 BioNet-Asia Co. Ltd. 相关的文献（医药）

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

INTRODUCTION:

Recombinant 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.

METHODS:

This 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.

RESULTS:

Anti-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.

CONCLUSIONS:

BioNet 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.

2023-07-01·Vaccine

A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in pregnant women

Article

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

INTRODUCTION:

Despite a decrease in infections caused by Bordetella pertussis due to COVID-19 pandemic, booster vaccination of pregnant women is still recommended to protect newborns. Highly immunogenic vaccines containing genetically inactivated pertussis toxin (PT_gen) and filamentous hemagglutinin (FHA) may generate comparable anti-PT antibody concentrations, even at lower doses, to chemically inactivated acellular pertussis vaccines (Tdap_chem) shown effective for maternal immunization.

METHODS:

This phase 2 randomized, observer-blind, active-controlled non-inferiority trial was conducted in healthy Thai pregnant women randomly assigned to receive one dose of low-dose recombinant pertussis-only vaccine containing 1 µg PT_gen and 1 µg FHA (ap1_gen), or tetanus, reduced-dose diphtheria combined with ap1_gen (Tdap1_gen), or combined with 2 µg PT_gen and 5 µg FHA (Tdap2_gen), or with 5 µg PT_gen and 5 µg FHA (TdaP5_gen, Boostagen®) or comparator containing 8 µg of chemically inactivated pertussis toxoid, 8 µg FHA, and 2.5 µg pertactin (Boostrix™, Tdap8_chem). Blood was collected at Day 0 and Day 28 post-vaccination. The non-inferiority of the study vaccines was assessed based on anti-PT IgG antibody levels on Day 28 pooled with results from a similarly structured previous trial in non-pregnant women.

RESULTS:

400 healthy pregnant women received one dose of vaccine. Combined with data from 250 non-pregnant women, all study vaccines containing PT_gen were non-inferior to comparator vaccine (Tdap8_chem). Both ap1_gen and TdaP5_gen vaccines could be considered to have superior immunogenicity to Tdap8_chem. Local and systemic solicited reactions were similar among all vaccine groups.

CONCLUSIONS:

Vaccine formulations containing PT_gen were safe and immunogenic in pregnant women. The ap1_gen vaccine, with the lowest cost and reactogenicity, may be suitable for use in pregnant women when diphtheria and tetanus toxoids are not needed. This study is registered in the Thai Clinical Trial Registry (www.

CLINICALTRIALS:

in.th), number TCTR20180725004.

2022-04-01·Vaccine3区 · 医学

A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in women of childbearing age

3区 · 医学

Article

作者: van den Biggelaar, Anita H J ; Andi-Lolo, Indah ; Rungmaitree, Supattra ; Kerdsomboon, Chawanee ; Jantarabenjakul, Watsamon ; Tang, Yuxiao ; Anugulruengkitt, Suvaporn ; Mansouri, Souad ; Chinwangso, Pailinrut ; Puthanakit, Thanyawee ; Suwitruengrit, Ladda ; Innis, Bruce L ; Holt, Renee ; Bhat, Niranjan ; Viviani, Simonetta ; Lapphra, Keswadee ; Fortuna, Librada ; Pham, Hong Thai ; Chokephaibulkit, Kulkanya

BACKGROUND:

A phase 2 randomized-controlled safety and immunogenicity trial evaluating different doses of recombinant acellular pertussis vaccine containing genetically-inactivated pertussis toxin (PT_gen) was conducted in women of childbearing age in Thailand to identify formulations to advance to a trial in pregnant women.

METHODS:

A total of 250 women were randomized 1:1:1:1:1 to receive one dose of one of three investigational vaccines including low-dose recombinant pertussis-only vaccine containing 1 μg PT_gen and 1 μg FHA (ap1_gen), tetanus, reduced-dose diphtheria (Td) combined to ap1_gen (Tdap1_gen) or combined to recombinant pertussis containing 2 μg PT_gen and 5 μg FHA (Tdap2_gen), or one dose of licensed recombinant TdaP vaccine containing 5 μg PT_gen and 5 μg FHA (Boostagen®, TdaP5_gen) or licensed Tdap vaccine containing 8 μg of chemically inactivated pertussis toxoid (PT_chem), 8 μg FHA, and 2.5 μg pertactin (PRN) (Boostrix^TM, Tdap8_chem). Serum Immunoglobulin G (IgG) antibodies against vaccine antigens were measured before and 28 days after vaccination by ELISA. To advance to a trial in pregnant women, formulations had to induce a PT-IgG seroresponse rate with a 95% confidence interval (95% CI) lower limit of ≥ 50%.

RESULTS:

Between 5 and 22 July 2018, a total of 250 women with median age of 31 years were enrolled. Post-vaccination PT-IgG seroresponse rates were 92% (95% CI 81-98) for ap1_gen, 88% (95% CI 76-95) for Tdap1_gen, 80% (95% CI 66-90) for Tdap2_gen, 94% (95% CI 83-99) for TdaP5_gen, and 78% (95% CI 64-88) for Tdap8_chem. Frequencies of injection site and systemic reactions were comparable between the groups. No serious adverse events were reported during the 28-day post-vaccination period.

CONCLUSIONS:

All recombinant acellular pertussis vaccines were safe and immunogenic in women of childbearing age, and all met pre-defined immunogenicity criteria to advance to a trial in pregnant women.

CLINICAL TRIAL REGISTRATION:

Thai Clinical Trial Registry, TCTR20180321004.

项与 BioNet-Asia Co. Ltd. 相关的新闻（医药）

2021-06-14

·GlobeNewswire

The Global Dengue Vaccine Market is expected to grow by $ 132.90 million during 2021-2025, progressing at a CAGR of about 18% during the forecast period

New York, June 14, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Dengue Vaccine Market 2021-2025" - Our report on the dengue vaccine market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors.The report offers an up-to-date analysis regarding the current global market scenario, latest trends and drivers, and the overall market environment. The market is driven by the rapid growth in disease prevalence and ineffective dengue control measures. In addition, rapid growth in disease prevalence is anticipated to boost the growth of the market as well.The dengue vaccine market analysis includes the end-user segment and geographic landscape.The dengue vaccine market is segmented as below:By End-user• Government institutions• Hospitals• NGOsBy Geographical Landscape• North America• Asia• Europe• ROWThis study identifies the initiatives for dengue vaccine research and dengue immunization programs as one of the prime reasons driving the dengue vaccine market growth during the next few years.The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters. Our report on dengue vaccine market covers the following areas:• Dengue vaccine market sizing• Dengue vaccine market forecast• Dengue vaccine market industry analysisThis robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading dengue vaccine market vendors that include BioNet-Asia Co. Ltd., Chula VRC, Codagenix Inc., GeneOne Life Science Inc., Imutex Ltd., KM Biologics Co. Ltd., Medigen Biotechnology Corp., Najít Technologies Inc., Sanofi SA, and Emergex Vaccines Holding Ltd. Also, the dengue vaccine market analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage all forthcoming growth opportunities.The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters such as profit, pricing, competition, and promotions. It presents various market facets by identifying the key industry influencers. The data presented is comprehensive, reliable, and a result of extensive research - both primary and secondary. Technavio’s market research reports provide a complete competitive landscape and an in-depth vendor selection methodology and analysis using qualitative and quantitative research to forecast the accurate market growth.Read the full report: ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.__________________________

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