Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2009-07-31
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating the Safety and Immune Response to a Dengue Virus Vaccine in Healthy Adults
NCT01931176
Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine
NCT01084291
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults
NCT00322946
Evaluating the Clinical and Immune Response to Two Dengue Virus Vaccines in Healthy Adults
NCT02392325
Safety of and Immune Response to DEN4 Vaccine Component Candidate for Dengue Virus
NCT00919178
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
10 µg DEN1-80E + 3.5 mg Alhydrogel
Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8.
DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.
50 µg DEN1-80E + 3.5 mg Alhydrogel
Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8.
DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.
Placebo
Administration of placebo vaccine at Weeks 0, 4, and 8.
Placebo for DEN1-80E
3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.
Placebo for DEN1-80E
3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body weight ≥ 110 pounds (50 kg).
* Satisfactory medical condition established by medical history and physical examination.
* Females must be of non-child bearing potential (i.e., surgically sterile) or, if of child-bearing potential must be abstinent or willing to employ adequate means of contraception.
Exclusion Criteria
* Abuse of drugs or alcohol within 12 months prior to screening.
* Use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids is allowed).
* Any confirmed or suspected immunosuppressive or immunodeficient condition.
* Receipt of any vaccination within 30 days prior to screening.
* Receipt of blood products within 6 months of screening.
* Previous flavivirus vaccination (e.g., Japanese encephalitis or yellow fever) or flavivirus vaccination planned during the study period.
* History of flavivirus infection.
* No easy access to a fixed or mobile telephone.
* History of residing in a country endemic for dengue, Japanese encephalitis virus, or Yellow Fever virus for a period of \> 1 year.
* Donation of ≥ 450 mL of blood within the previous 12 weeks.
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hawaii Biotech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hawaii Biotech, Inc
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Beth-Ann Coller, PhD
Role: STUDY_DIRECTOR
Hawaii Biotech, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Saint Louis University
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Durbin AP, Pierce KK, Kirkpatrick BD, Grier P, Sabundayo BP, He H, Sausser M, Russell AF, Martin J, Hyatt D, Cook M, Sachs JR, Lee AW, Wang L, Coller BA, Whitehead SS. Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial. Am J Trop Med Hyg. 2020 Aug;103(2):855-863. doi: 10.4269/ajtmh.20-0042. Epub 2020 May 7.
Manoff SB, George SL, Bett AJ, Yelmene ML, Dhanasekaran G, Eggemeyer L, Sausser ML, Dubey SA, Casimiro DR, Clements DE, Martyak T, Pai V, Parks DE, Coller BA. Preclinical and clinical development of a dengue recombinant subunit vaccine. Vaccine. 2015 Dec 10;33(50):7126-34. doi: 10.1016/j.vaccine.2015.09.101. Epub 2015 Oct 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HBV-001-C-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.