Dengue VirusPhase 1NCT01084291
Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine
A Phase 1 study testing Investigational Vaccine for DEN1 in people with Dengue Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. There are four types of dengue virus, and infection with one does not offer protection against the others. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Virus
- What is being tested?
- Investigational Vaccine for DEN1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Jun 2010
- 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
- In good general health as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study, including approximately 6 weeks post-vaccination
- Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial
Who cannot join
- Currently breast-feeding or pregnant
- Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
- Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, and serum creatinine, as defined in this protocol
- Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
- Significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by participant history
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- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the last 6 months)
- Presence of HIV infection, determined by screening and confirmatory assays
- Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays
- Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening
- Presence of any known immunodeficiency syndrome
- Uses anticoagulant medications
- Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days.
- Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipated receipt of any vaccine during the 42 days following vaccination
- Has no spleen
- Received blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination
- History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
- Has received a flavivirus vaccine (licensed or experimental)
- Anticipates receipt of any investigational agent in the 42 days before or after vaccination
- Participant has definite plans to travel to a dengue endemic area during the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fletcher Allen Health Care (FAHC) General Clinical Research Center (GCRC)
Burlington, Vermont, 05401
University of Vermont Vaccine Testing Center
Burlington, Vermont, 05401
About this study
Official title: A Phase I Evaluation of the Safety and Immunogenicity of the rDEN1∆30 Dengue Serotype 1 Vaccine Given at a Single Dose of 101 PFU in Healthy Flavivirus-naïve Adult Subjects
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. There are four types of dengue virus, and infection with one does not offer protection against the others. This study will test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes a response in people's immune system and is safe.
Read the detailed description
The dengue virus causes approximately 50 million cases of dengue fever and 1.5 million cases of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every year. There are four subtypes of the virus, and infection with one offers no protection from infection by the others. In fact, most cases of DHS and DSS occur in people infected by more than one subtype. In areas of the world where multiple subtypes of dengue are common, vaccines must be developed against each of the subtypes of dengue virus. This study will examine the safety and immune response of an investigational vaccine for preventing infection with DEN1.
Participation in this study will last about 6 weeks. Participants will be randomly assigned to be injected with either the investigational study vaccine or a placebo. Participants will have a five in six chance of receiving the vaccine. The first study visit will take place on the vaccination day, on which participants will undergo a physical examination, blood draw, and pregnancy test, and then receive the vaccine. Participants will be given a thermometer and temperature card, and be told to record their temperature three times per day for 16 days after vaccination. Participants will come to follow-up visits every other day for the 16 days after vaccination, and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42). Assessments completed during these visits will include a questionnaire about how the participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical exam. Blood drawn will be analyzed to check participants' health, determine the amount of vaccine and antibodies in the blood, test markers in white blood cells and genes, and look for proteins that are important for fighting dengue infection.
- Conditions
- Dengue Virus
- Being tested
- Investigational Vaccine for DEN1, Placebo injection
- Keywords
- Vaccine, Dengue Hemorrhagic Fever
- Medical subject headings
- Severe Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Vaccine for DEN1Biological
Also called rDEN1∆30 vaccine
Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
Placebo injectionOther
Subcutaneous injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| DEN1 Vaccine | Experimental | Participants will receive a single dose of investigational vaccine for dengue virus subtype 1. Receives: Biological: Investigational Vaccine for DEN1 |
| Placebo | Placebo comparator | Participants will receive a single dose of placebo vaccine. Receives: Other: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related adverse events (AEs), as classified by both severity and seriousness, through active and passive surveillance
Measured: Measured throughout study
Immunogenicity to dengue virus subtype one (DEN1), as assessed by neutralizing antibody titers
Measured: Measured 4 and 6 weeks after vaccination
Secondary outcomes (3)
Frequency, quantity, and duration of viremia following vaccination
Measured: Measured every other day after vaccination for 16 days, and on Days 21, 28, and 42
Number of vaccinees infected with DEN1, defined as recovery of vaccine virus from the blood or serum of a participant and/or by seroconversion to DEN1
Measured: Measured at study completion
Comparison of the infectivity rates, safety, and immunogenicity of a single dose of DEN1 vaccine to those rates of previous clinical trials
Measured: Measured at study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionJun 2010
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 VirusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anna Durbin, MD, Principal investigator, CIR, Johns Hopkins UniversityBeth Kirkpatrick, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084291
- Sponsor's protocol ID
- CIR 253
- Status last verified
- Dec 2012
- First submitted
- 8 Mar 2010
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
PubMed 16553547Whitehead SS, Falgout B, Hanley KA, Blaney JE Jr, Markoff L, Murphy BR. A live, attenuated dengue virus type 1 vaccine candidate with a 30-nucleotide deletion in the 3' untranslated region is highly attenuated and immunogenic in monkeys. J Virol. 2003 Jan;77(2):1653-7. doi: 10.1128/jvi.77.2.1653-1657.2003.
PubMed 12502885
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Evaluation of the Safety and Immunogenicity of the rDEN1∆30 Dengue Serotype 1 Vaccine Given at a Single Dose of 101 PFU in Healthy Flavivirus-naïve Adult Subjects
- ClinicalTrials.gov ID
- NCT01084291
- Acronym / sponsor ID
- CIR 253
- Conditions
- Dengue Virus
- Keywords
- Vaccine, Dengue Hemorrhagic Fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Mar 2010 (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.
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. There are four types of dengue virus, and infection with one does not offer protection against the others. This study will test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes a response in people's immune system and is safe.
Detailed description
The dengue virus causes approximately 50 million cases of dengue fever and 1.5 million cases of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every year. There are four subtypes of the virus, and infection with one offers no protection from infection by the others. In fact, most cases of DHS and DSS occur in people infected by more than one subtype. In areas of the world where multiple subtypes of dengue are common, vaccines must be developed against each of the subtypes of dengue virus. This study will examine the safety and immune response of an investigational vaccine for preventing infection with DEN1.
Participation in this study will last about 6 weeks. Participants will be randomly assigned to be injected with either the investigational study vaccine or a placebo. Participants will have a five in six chance of receiving the vaccine. The first study visit will take place on the vaccination day, on which participants will undergo a physical examination, blood draw, and pregnancy test, and then receive the vaccine. Participants will be given a thermometer and temperature card, and be told to record their temperature three times per day for 16 days after vaccination. Participants will come to follow-up visits every other day for the 16 days after vaccination, and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42). Assessments completed during these visits will include a questionnaire about how the participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical exam. Blood drawn will be analyzed to check participants' health, determine the amount of vaccine and antibodies in the blood, test markers in white blood cells and genes, and look for proteins that are important for fighting dengue infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEN1 Vaccine | Experimental | Biological: Investigational Vaccine for DEN1Participants will receive a single dose of investigational vaccine for dengue virus subtype 1. |
| Placebo | Placebo comparator | Other: Placebo injectionParticipants will receive a single dose of placebo vaccine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- In good general health as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study, including approximately 6 weeks post-vaccination
- Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial
Key exclusion criteria (21 listed)
- Currently breast-feeding or pregnant
- Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
- Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, and serum creatinine, as defined in this protocol
- Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
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 |
|---|---|---|
| Investigational Vaccine for DEN1Also: rDEN1∆30 vaccineSubcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU) | Biological | DEN1 Vaccine |
| Placebo injectionSubcutaneous injection of placebo | Other | Placebo |
Primary outcome
Frequency of vaccine-related adverse events (AEs), as classified by both severity and seriousness, through active and passive surveillance
Time frame: Measured throughout study
Immunogenicity to dengue virus subtype one (DEN1), as assessed by neutralizing antibody titers
Time frame: Measured 4 and 6 weeks after vaccination
3 secondary outcomes
Frequency, quantity, and duration of viremia following vaccination
Time frame: Measured every other day after vaccination for 16 days, and on Days 21, 28, and 42
Number of vaccinees infected with DEN1, defined as recovery of vaccine virus from the blood or serum of a participant and/or by seroconversion to DEN1
Time frame: Measured at study completion
Comparison of the infectivity rates, safety, and immunogenicity of a single dose of DEN1 vaccine to those rates of previous clinical trials
Time frame: Measured at study completion
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 3 Jan 2013.
- Background: PubMed 16553547Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
- Background: PubMed 12502885Whitehead SS, Falgout B, Hanley KA, Blaney JE Jr, Markoff L, Murphy BR. A live, attenuated dengue virus type 1 vaccine candidate with a 30-nucleotide deletion in the 3' untranslated region is highly attenuated and immunogenic in monkeys. J Virol. 2003 Jan;77(2):1653-7. doi: 10.1128/jvi.77.2.1653-1657.2003.
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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.
Anna Durbin, MD principal investigator
CIR, Johns Hopkins University
Beth Kirkpatrick, MD principal investigator
University of Vermont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational Vaccine for DEN1 in people with Dengue Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 3 inclusion and 21 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 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Frequency of vaccine-related adverse events (AEs), as classified by both severity and seriousness, through active and passive surveillance (time frame: Measured throughout study). The study lists 2 primary outcomes in all. 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 NCT01084291, 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 3 Jan 2013.