Dengue FeverPhase 1NCT00936429
Study of HBV-001 D1 in Healthy Adults
A Phase 1 study testing DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel) in people with Dengue Fever, run by Hawaii Biotech, Inc. at 1 site in United States.
Trial summary
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- What is being tested?
- DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females age 18 to 45.
- 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.
Who cannot join
- Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.
Read the detailed description
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts. Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.
- Conditions
- Dengue Fever
- Being tested
- DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel), Placebo for DEN1-80E
- Keywords
- Dengue fever, Dengue hemorrhagic fever, Dengue shock syndrome, Vaccine, Hawaii Biotech
- Medical subject headings
- Dengue, Severe Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)Biological
Also called HBV-001 D1
3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.
Placebo for DEN1-80EBiological
3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.
| Study group | Role | What they receive |
|---|---|---|
| 10 µg DEN1-80E + 3.5 mg Alhydrogel | Experimental | Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8. Receives: Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel) |
| 50 µg DEN1-80E + 3.5 mg Alhydrogel | Experimental | Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8. Receives: Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel) |
| Placebo | Placebo comparator | Administration of placebo vaccine at Weeks 0, 4, and 8. Receives: Biological: Placebo for DEN1-80E |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data
Measured: Assessed at each study visit
Secondary outcomes (1)
To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses
Measured: Every 2 weeks during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawaii Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Beth-Ann Coller, PhD, Study director, Hawaii Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936429
- Sponsor's protocol ID
- HBV-001-C-101
- Status last verified
- Feb 2011
- First submitted
- 8 Jul 2009
- Last updated
- 7 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32394880Manoff 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.
PubMed 26458804
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults
- ClinicalTrials.gov ID
- NCT00936429
- Acronym / sponsor ID
- HBV-001-C-101
- Conditions
- Dengue Fever
- Keywords
- Dengue fever, Dengue hemorrhagic fever, Dengue shock syndrome, Vaccine, Hawaii Biotech
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hawaii Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.
Detailed description
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts. Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 µg DEN1-80E + 3.5 mg Alhydrogel | Experimental | Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8. |
| 50 µg DEN1-80E + 3.5 mg Alhydrogel | Experimental | Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8. |
| Placebo | Placebo comparator | Biological: Placebo for DEN1-80EAdministration of placebo vaccine at Weeks 0, 4, and 8. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males or females age 18 to 45.
- 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.
Key exclusion criteria (11 listed)
- Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)Also: HBV-001 D13 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid. | Biological | 10 µg DEN1-80E + 3.5 mg Alhydrogel, 50 µg DEN1-80E + 3.5 mg Alhydrogel |
| Placebo for DEN1-80E3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid. | Biological | Placebo |
Primary outcome
To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data
Time frame: Assessed at each study visit
1 secondary outcome
To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses
Time frame: Every 2 weeks during treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2011.
- Derived from this study: PubMed 32394880Durbin 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.
- Derived from this study: PubMed 26458804Manoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth-Ann Coller, PhD study director
Hawaii Biotech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel) in people with Dengue Fever, run by Hawaii Biotech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data (time frame: Assessed at each study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00936429, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2011.