tetanus/diphtheria/pertussis booster vaccine (Tdap-1018) / Dynavax, Serum Institute of India - LARVOL DELTA

Extension study of DV2-TDAP-01 to assess immunogenicity of Tdap-1018 to pertussis antigens. (ANZCTR) - P=N/A | N=57 | Completed | Sponsor: Dynavax Technologies Corporation | Recruiting ➔ Completed

Trial completion • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Phase 1 trial of an investigational Tdap booster vaccine with CpG 1018 adjuvant compared with Boostrix in healthy adults and adolescents. (PubMed, Vaccine) - "Tdap-1018 3000 μg induced similar or higher immune responses than Boostrix. ACTRN12620001177943 (Australian New Zealand Clinical Trials Registry; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12620001177943p)."

Journal • P1 data • Infectious Disease • Pain • Pertussis • Respiratory Diseases • Tetanus

Extension study of DV2-TDAP-01 to assess immuno of Tdap-1018 to pertussis antigens. (ANZCTR) - P=N/A | N=57 | Recruiting | Sponsor: Dynavax Technologies Corporation

New trial • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Safety, Tolerability, and Pertussis Immunogenicity Findings From a Randomized, Participant-Blinded, Active-Controlled, Dose-Escalating, Phase 1 Trial of a Tetanus/Diphtheria/Pertussis Booster Vaccine (Tdap-1018 CpG Adjuvanted) Compared With Boostrix in Healthy Adults Aged 18 to 22 Years (IDWeek 2022) - No abstract available

Clinical • P1 data • Infectious Disease • Pertussis • Tetanus

Dynavax Highlights 2022 Priorities and Announces Initiation of Phase 1 Clinical Trial for Its Shingles Vaccine Candidate (PRNewswire) - "Initiation of Phase 1 clinical trial of shingles vaccine candidate, adjuvanted with CpG 1018, with data expected year end 2022...Dynavax anticipates continued profitability in 2022 driven by its CpG 1018 adjuvant supply business for COVID-19 vaccines and increasing HEPLISAV-B sales...CpG 1018 Adjuvant Supply Business for COVID-19 Vaccines...Additional regulatory authorization for partners' COVID-19 vaccines anticipated in the first half of 2022...Topline data is expected in the first half of 2022 from the Company's ongoing Tdap-1018 phase 1 clinical trial evaluating the safety, tolerability, and immunogenicity in adults with adolescent data expected in the second half of 2022."

Commercial • P1 data • Regulatory • Hepatitis B • Infectious Disease • Pertussis

Dynavax Announces Second Quarter 2021 Financial Results (PRNewswire) - "Second quarter 2021 total revenue of $52.8 million, which includes HEPLISAV-B's highest quarterly revenue to date at $13.7 million...CDC Advisory Committee on Immunization Practices expected to vote on a universal hepatitis b recommendation for all previously unvaccinated adults in October...Data from Tdap-1018 in the ongoing Phase 1 clinical trial, for an improved tetanus, diphtheria, and acellular pertussis booster vaccine candidate adjuvanted with CpG 1018 expected in first quarter 2022."

P1 data • Sales • Hepatitis B • Infectious Disease • Pertussis

Dynavax Announces First Quarter 2021 Financial Results (PRNewswire) - "Net product revenue for HEPLISAV-B during the first quarter 2021 was $8.3 million compared to $10.5 million for the first quarter 2020, driven by increased market share offset by a reduction in vaccine utilization due to the COVID-19 pandemic...Final immunogenicity and interim safety results of the ongoing clinical trial...Full safety data are expected by the end of 2021...Data from the ongoing Phase 1 clinical trial of Tdap-1018 in the fourth quarter. Launch HEPLISAV-B in the EU in the fourth quarter...Cost of Sales - Product. Cost of sales - product for the first quarter 2021 increased to $24.6 million, compared to $2.4 million for the first quarter of 2020. The increase was primarily due to manufacturing costs for CpG 1018."

Clinical data • Launch Europe • P1 data • Sales • Hepatitis B • Infectious Disease • Pertussis