DenguePhase 1NCT02684383
Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
A Phase 1 study testing rDEN3∆30 in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- rDEN3∆30
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Jul 2016
- 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
- Adult male or female between 18 and 50 years of age, inclusive.
- Good general health as determined by physical examination, laboratory screening, and review of medical history.
- Available for the duration of the study, approximately 26 weeks post-vaccination.
- Willingness and availability for potential inpatient admission in the inpatient unit following receipt of rDEN3Δ30.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Females Only: Female subjects of childbearing potential willing to use effective contraception beginning long enough before dosing to ensure method specific efficacy for the duration of the trial. Reliable methods of contraception include hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (greater than or equal to 6 months since last sexual encounter). All female subjects will be considered having childbearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.
Who cannot join
- Females Only: Currently pregnant, as determined by positive beta-human chorionic gonadotropin (HCG) test, or breastfeeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
- Confirmed screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol. Confirmation will be obtained by repeating the test to ensure the abnormal value was not due to aberrancy.
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
- Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational or family problems, as indicated by subject 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).
- HIV infection, by screening and confirmatory assays.
- Hepatitis C virus (HCV) infection, by screening and confirmatory assays.
- Hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening.
- Any known immunodeficiency syndrome.
- Use of anticoagulant medications.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. 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.
- Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination.
- Asplenia.
- Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination.
- History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis virus, or West Nile virus).
- Previous receipt of a flavivirus vaccine (licensed or experimental).
- Anticipated receipt of any investigational agent in the 28 days before or after vaccination.
- Subject has definite plans to travel to a dengue-endemic area during the study.
- Known allergy to antipyretics.
- Refusal to allow storage of specimens for future research.
- Other Treatments and Ongoing Exclusion Criteria:
- The following criteria will be reviewed on days 28 and 56 post-vaccination. If any become applicable during the study, then the subject will not be included in further immunogenicity evaluations, as of the exclusionary visit. The subject will, however, be encouraged to remain in the study for safety evaluations for the duration of the study.
- Ongoing Exclusion Criteria:
- Use of any investigational drug or investigational vaccine other than the study vaccine during the 28-day period post-vaccination.
- Chronic administration (greater than or equal to 14 days) of steroids (defined as prednisone equivalent of greater than or equal to 10 mg per day), immunosuppressants, or other immune-modifying drugs initiated during the 28-day period post-vaccination (topical and nasal steroids are allowed).
- Receipt of a licensed vaccine during the 28-day period post vaccination.
- Receipt of immunoglobulins and/or any blood products during the 28-day period post vaccination.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Immunization Research (CIR), Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: A Phase 1 Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the safety and immunogenicity of a live attenuated monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous flavivirus infection.
Read the detailed description
The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated monovalent dengue virus vaccine (rDEN3Δ30) in healthy flavivirus-naive adults.
Participants will be randomly assigned to receive the rDEN3Δ30 vaccine or placebo at Day 0. Study visits will occur on Days 2, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits will include physical examinations and blood collection. All participants will record their temperature 3 times a day from Day 0 through Day 16. Some participants may be admitted to the clinic for an inpatient (overnight) stay during the first 16 days of the study.
- Conditions
- Dengue
- Being tested
- rDEN3∆30, Placebo
- Keywords
- 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.
rDEN3∆30Biological
10^3 plaque-forming units (PFUs); administered by subcutaneous injection in the deltoid region of the upper arm
PlaceboBiological
Administered by subcutaneous injection in the deltoid region of the upper arm
| Study group | Role | What they receive |
|---|---|---|
| rDEN3∆30 vaccine | Experimental | Participants will receive the rDEN3∆30 vaccine at Day 0. Receives: Biological: rDEN3∆30 |
| Placebo | Placebo comparator | Participants will receive placebo at Day 0. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related adverse events (AEs)
Measured: Measured through Day 28 post-vaccination
Level of anti-DENV-3 neutralizing antibody
Measured: Measured through Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies 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
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kristen Pierce, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684383
- Sponsor's protocol ID
- CIR 304
- Status last verified
- Nov 2016
- First submitted
- 16 Feb 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
- ClinicalTrials.gov ID
- NCT02684383
- Acronym / sponsor ID
- CIR 304
- Conditions
- Dengue
- Keywords
- Dengue Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Feb 2016 (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.
Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the safety and immunogenicity of a live attenuated monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous flavivirus infection.
Detailed description
The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated monovalent dengue virus vaccine (rDEN3Δ30) in healthy flavivirus-naive adults.
Participants will be randomly assigned to receive the rDEN3Δ30 vaccine or placebo at Day 0. Study visits will occur on Days 2, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits will include physical examinations and blood collection. All participants will record their temperature 3 times a day from Day 0 through Day 16. Some participants may be admitted to the clinic for an inpatient (overnight) stay during the first 16 days of the study.
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 |
|---|---|---|
| rDEN3∆30 vaccine | Experimental | Biological: rDEN3∆30Participants will receive the rDEN3∆30 vaccine at Day 0. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo at Day 0. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult male or female between 18 and 50 years of age, inclusive.
- Good general health as determined by physical examination, laboratory screening, and review of medical history.
- Available for the duration of the study, approximately 26 weeks post-vaccination.
- Willingness and availability for potential inpatient admission in the inpatient unit following receipt of rDEN3Δ30.
- Willingness to participate in the study as evidenced by signing the informed consent document.
Key exclusion criteria (31 listed)
- Females Only: Currently pregnant, as determined by positive beta-human chorionic gonadotropin (HCG) test, or breastfeeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
- Confirmed screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol. Confirmation will be obtained by repeating the test to ensure the abnormal value was not due to aberrancy.
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject 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 |
|---|---|---|
| rDEN3∆3010^3 plaque-forming units (PFUs); administered by subcutaneous injection in the deltoid region of the upper arm | Biological | rDEN3∆30 vaccine |
| PlaceboAdministered by subcutaneous injection in the deltoid region of the upper arm | Biological | Placebo |
Primary outcome
Frequency of vaccine-related adverse events (AEs)
Time frame: Measured through Day 28 post-vaccination
Level of anti-DENV-3 neutralizing antibody
Time frame: Measured through Day 180
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 30 Nov 2016.
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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.
Kristen Pierce, 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 rDEN3∆30 in people with Dengue, 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 6 inclusion and 31 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 30 Nov 2016. 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) (time frame: Measured through Day 28 post-vaccination). 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?
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 30 Nov 2016.