Dengue FeverPhase 1DENV-1 PIVNCT01502735
Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease
A Phase 1 study testing DENV-1 PIV, 2.5 µg and DENV-1 PIV, 5 µg in people with Dengue Fever, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- What is being tested?
- DENV-1 PIV, 2.5 µg and DENV-1 PIV, 5 µg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Sep 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18 years of age or the legal age of consent (whichever is greater) to 50 (inclusive) years of age
- Negative screening laboratory test against dengue, Japanese Encephalitis, West Nile, and Yellow Fever viruses
- Healthy
- All subjects must agree to use contraception or to abstain from sex from enrollment through trial completion
- Able to provide informed consent and able to be followed throughout the trial period
Who cannot join
- History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, West Nile virus, Yellow fever, and dengue
- Have a known or suspected hypersensitivity or adverse reaction to vaccines
- Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0
- Are pregnant or breastfeeding
- Known HIV, Hepatitis B and/or Hepatitis C infection
- Have any acute illness, including an oral body temperature greater than 100.4°F at the day of vaccination
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- Have any occupational, social, or medical concerns that would impact subject safety, interfere with protocol adherence, or affect a subject's ability to give informed consent
- Have been using immunomodulatory therapy (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) within the past 6 months; medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to the initial injection
- Have received an investigational drug or vaccine or participated in a drug product or vaccine study within a period of 30 days prior to Day 0
- Have received or donated blood or plasma within 90 days of Day 0 (or plan on receiving or donating blood or plasma during the study)
Trial locations and contacts
1 site in 1 country.
United States1 site
WRAIR, Clinical Trials Center (CTC)
Silver Spring, Maryland, 20910
About this study
Official title: A Phase 1 Trial of the Walter Reed Army Institute of Research (WRAIR) Dengue Virus Serotype-1 Purified Inactivated Vaccine (DENV-1 PIV) in Flavivirus Antibody Naïve Adults
This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.
Read the detailed description
DENV infections can cause self-limited but incapacitating acute illness lasting four to seven days. The illness is characterized by fever, headache, severe pain in muscles, joints, pain behind the eyes, and a rash. DENV infection can be complicated by the development of hemorrhagic fever (DHF) or shock syndrome (DSS), which is manifested by plasma leakage and a bleeding diathesis or frank hemorrhage. DHF is fatal in at least 0.5% of pediatric cases but rarely in adults. People, particularly children, living in hyper-endemic areas who have antibodies from an earlier dengue infection with one serotype are at increased risk for DHF if subsequently infected by another dengue virus serotype.
Currently, no specific anti-viral therapy exists. Therapy is largely supportive. Mosquito control has failed to prevent dengue transmission; therefore, prevention of dengue through vaccination is an important objective of the World Health Organization (WHO) and many national governments, including the United States.
- Conditions
- Dengue Fever
- Being tested
- DENV-1 PIV, 2.5 µg, DENV-1 PIV, 5 µg
- Keywords
- dengue, dengue fever, monovalent dengue vaccine
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DENV-1 PIV, 2.5 µgBiological
2.5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)
DENV-1 PIV, 5 µgBiological
5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)
| Study group | Role | What they receive |
|---|---|---|
| DENV-1 PIV (high dose) | Experimental | Not described Receives: Biological: DENV-1 PIV, 5 µg |
| DENV-1 PIV (low dose) | Experimental | Not described Receives: Biological: DENV-1 PIV, 2.5 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with solicited adverse events (AEs) from study day 0 to 90
Measured: Up to 90 days
Number of subjects with unsolicited AEs from study day 0 to 90
Measured: Up to 90 days
Number of subjects who experience serious adverse events (SAEs) during the study period
Measured: Up to 360 Days
Secondary outcomes (2)
Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4
Measured: Up to Day 28
Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephen Thomas, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502735
- Sponsor's protocol ID
- S-10-0003
- Other IDs
- WRAIR IRB Protocol # 1856, HSRRB Protocol #: A-17104, IND 14338
- Acronym
- DENV-1 PIV
- Status last verified
- Apr 2015
- First submitted
- 16 Dec 2011
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of the Walter Reed Army Institute of Research (WRAIR) Dengue Virus Serotype-1 Purified Inactivated Vaccine (DENV-1 PIV) in Flavivirus Antibody Naïve Adults
- ClinicalTrials.gov ID
- NCT01502735
- Acronym / sponsor ID
- DENV-1 PIV / S-10-0003
- Conditions
- Dengue Fever
- Keywords
- dengue, dengue fever, monovalent dengue vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Dec 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Jan 2012 (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 phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.
Detailed description
DENV infections can cause self-limited but incapacitating acute illness lasting four to seven days. The illness is characterized by fever, headache, severe pain in muscles, joints, pain behind the eyes, and a rash. DENV infection can be complicated by the development of hemorrhagic fever (DHF) or shock syndrome (DSS), which is manifested by plasma leakage and a bleeding diathesis or frank hemorrhage. DHF is fatal in at least 0.5% of pediatric cases but rarely in adults. People, particularly children, living in hyper-endemic areas who have antibodies from an earlier dengue infection with one serotype are at increased risk for DHF if subsequently infected by another dengue virus serotype.
Currently, no specific anti-viral therapy exists. Therapy is largely supportive. Mosquito control has failed to prevent dengue transmission; therefore, prevention of dengue through vaccination is an important objective of the World Health Organization (WHO) and many national governments, including the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DENV-1 PIV (high dose) | Experimental | Biological: DENV-1 PIV, 5 µg |
| DENV-1 PIV (low dose) | Experimental | Biological: DENV-1 PIV, 2.5 µg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females 18 years of age or the legal age of consent (whichever is greater) to 50 (inclusive) years of age
- Negative screening laboratory test against dengue, Japanese Encephalitis, West Nile, and Yellow Fever viruses
- Healthy
- All subjects must agree to use contraception or to abstain from sex from enrollment through trial completion
- Able to provide informed consent and able to be followed throughout the trial period
Key exclusion criteria (10 listed)
- History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, West Nile virus, Yellow fever, and dengue
- Have a known or suspected hypersensitivity or adverse reaction to vaccines
- Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0
- Are pregnant or breastfeeding
- Known HIV, Hepatitis B and/or Hepatitis C infection
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 |
|---|---|---|
| DENV-1 PIV, 2.5 µg2.5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days) | Biological | DENV-1 PIV (low dose) |
| DENV-1 PIV, 5 µg5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days) | Biological | DENV-1 PIV (high dose) |
Primary outcome
Number of subjects with solicited adverse events (AEs) from study day 0 to 90
Time frame: Up to 90 days
Number of subjects with unsolicited AEs from study day 0 to 90
Time frame: Up to 90 days
Number of subjects who experience serious adverse events (SAEs) during the study period
Time frame: Up to 360 Days
2 secondary outcomes
Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4
Time frame: Up to Day 28
Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4
Time frame: Up to Day 90
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 22 Apr 2015.
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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.
Stephen Thomas, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
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 DENV-1 PIV, 2.5 µg and DENV-1 PIV, 5 µg in people with Dengue Fever, run by U.S. Army Medical Research and Development Command 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 5 inclusion and 10 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 22 Apr 2015. 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. 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?
Number of subjects with solicited adverse events (AEs) from study day 0 to 90 (time frame: Up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2015.