Drugs / Boostagen
last change Jan 2024 re-read 3 minutes ago

Boostagen

Developed for
pertussis
Investigated by
BioNet-Asia Co., Ltd. · MU-JHU CARE · Medical Research Council · Public Health England · St George's, University of London · University of British Columbia

Trials 1

202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT04589312 Oct 2020 → Jun 2023 pertussis St George's, University of London Completed Mixed

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2024-01-12 BioNet-Asia Co., Ltd. Results Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines bionet-asia.com ↗
PT GMC in infants at birth were ≥30 IU/mL in all groups with the highest titers in infants found in TdaP5gen group at birth (118.8 [95% CI 93.9–150.4]).
2023-12-12 BioNet-Asia Co., Ltd. Results Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines bionet-asia.com ↗
PT GMC in infants at birth were ≥30 IU/mL in all groups with the highest titers in infants found in TdaP5gen group at birth (118.8 [95% CI 93.9–150.4]).
2023-06-22 BioNet-Asia Co., Ltd. Results A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in pregnant women bionet-asia.com ↗
Combined with data from 250 non-pregnant women, all study vaccines containing PTgen were non-inferior to comparator vaccine (Tdap8chem).
2022-04-05 BioNet-Asia Co., Ltd. Results A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in women of childbearing age bionet-asia.com ↗
Post-vaccination PT-IgG seroresponse rates were 92% (95% CI 81–98) for ap1gen, 88% (95% CI 76–95) for Tdap1gen, 80% (95% CI 66–90) for Tdap2gen, 94% (95% CI 83–99) for TdaP5gen, and 78% (95% CI 64–88) for Tdap8chem.
2020-12-05 BioNet-Asia Co., Ltd. Results Enhanced post-licensure safety surveillance of a new recombinant acellular pertussis vaccine licensed as a monovalent (aP, Pertagen®) and tetanus, reduced-dose diphtheria combination (TdaP, Boostagen®) vaccine for immunization of adolescents and adults in Thailand bionet-asia.com ↗
There were no vaccine-related serious adverse events reported during the surveillance period.

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Boostagen ClinicalTrials.gov intervention name — accepted as the source's own label NCT04589312 ↗