Advancing a broad pipeline of vaccines to prevent infectious diseases.
1 APPROVED: U.S. Commercial launch Q1 2018; EU Commercial launch Q2 2022
2 Commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B in Germany
3 Phase 2 clinical trial to be conducted in collaboration with, and funded by, the U.S. Department of Defense
* The information provided in this section was last updated October 1, 2022. For more information, please see partner websites.
Clinical Trials
New vaccines that potentially help protect people are only possible because of volunteers who participate in clinical research. Joining a clinical trial is an important decision that should be discussed with a healthcare provider.
DV2-TDAP-01
Overview
A Phase 1 randomized, participant-blinded, active-controlled, dose escalation, clinical trial to evaluate the safety, tolerability, and immunogenicity of an investigational tetanus/diphtheria/pertussis (Tdap) booster vaccine utilizing CpG 1018 adjuvant compared to a licensed Tdap vaccine in healthy volunteers between 10 and 22 years of age. The trial is being conducted in Australia.
Title: A study to evaluate the safety and tolerability of Tetanus/Diphtheria/Pertussis Booster Vaccine compared to a licensed Tdap vaccine in Healthy Volunteers between 10 - 22 years of age
Status: Completed
RESULTS: Phase 1 data demonstrated the vaccine candidate was well tolerated without safety concerns. Additionally, immunogenicity results in adults were consistent with our expectations and support our plan to continue advancement of the vaccine program.
Anzctr.org.au Identifier: ACTRN12620001177943p
These molecules and their uses are investigational, have not been proven to be safe, and have not been approved by the U.S. Food and Drug Administration or by any health authority.
DV2-ZOS-01
Overview
A Phase 1 randomized, active-controlled, dose-escalation, clinical trial to evaluate the safety, tolerability, and immunogenicity of investigational herpes zoster (shingles) vaccine utilizing CpG 1018 adjuvant compared to Shingrix® in healthy volunteers between the ages of 50 and 69 years of age.
Title: A Phase 1 Randomized, Subject-Blinded, Active-Controlled, Dose Escalation, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers Between the Ages of 50 and 69 Years.
Status: Completed
ClinicalTrials.gov NCT Identifier: NCT05245838
These molecules and their uses are investigational, have not been proven to be safe, and have not been approved by the U.S. Food and Drug Administration or by any health authority.
DV2-PLG-01
Overview
A Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety and tolerability of rF1V vaccine with CpG 1018 adjuvant compared with rF1V vaccine alone in adults. Approximately 200 healthy adults will be enrolled in the U.S.
Title: Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Status: Active, not recruiting
ClinicalTrials.gov NCT Identifier: NCT05506969
DV2-HBV-27 (Pregnancy Registry)
The HEPLISAV-B pregnancy registry is an observational study being conducted in the United States to evaluate pregnancy outcomes in women vaccinated with HEPLISAV-B® within 28 days prior to conception or at any time during pregnancy. The purpose of the registry is to learn more about the health of infants born to mothers exposed to HEPLISAV-B® during pregnancy. The registry is sponsored by Dynavax Technologies and PPD, Inc.
Title: HEPLISAV-B® Pregnancy Registry: an observational study on the safety of HEPLISAV-B exposure in pregnant women and their offspring
Status: Active, not recruiting
Learn more: HEPLISAV-B Pregnancy Registry
Contact Information
Toll-free number: 1-844-443-7734
Email: heplisavbpregnancyregistry@ppdi.com
ClinicalTrials.gov NCT Identifier: NCT03664648