DenguePhase 1NCT02433652
Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
A Phase 1 study testing Recombinant live attenuated trivalent dengue vaccine and rDEN2Δ30-7169 vaccine 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?
- Recombinant live attenuated trivalent dengue vaccine and rDEN2Δ30-7169 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Nov 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-second vaccination
- Willingness to participate in the study as evidenced by signing the informed consent document
- Females Only: Female participants of childbearing potential willing to use effective contraception. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, abstinence (6 months or longer since last sexual encounter). All female participants will be considered having child-bearing 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.
- Good general health as determined by physical examination and review of medical history
- Available for the duration of the study, approximately 26 weeks after the second dose
- Females Only: Female participants of childbearing potential willing to use effective contraception. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, abstinence (6 months or longer since last sexual encounter). All female participants will be considered having child-bearing 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 choriogonadotropin (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, psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the requirements of the study protocol
- Screening laboratory values of Grade 1 or above for absolute neutrophil (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol
- Any condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant 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 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)
- HIV infection, by screening and confirmatory assays
- Hepatitis C virus (HCV) infection, by screening and confirmatory assays
- Hepatitis B virus (HBV), by HBV 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 of serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis virus, 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
- Participant has definite plans to travel to a dengue endemic area during the study
- Refusal to allow storage of specimen for future research
- Anaphylaxis or angioedema following the first dose of vaccine
- Females only: Currently pregnant, as determined by positive beta-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, psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the requirements of the study protocol
- Any condition that in the opinion of the investigator would jeopardize the safety or rights of a participant to understand and cooperate with the requirements of the study protocol
- Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant history
- 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
- HCV infection, by screening and confirmatory assays
- HBV infection, by 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 inoculation. 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 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
- Anticipated receipt of any other investigational agent in the 28 days before or after vaccination
- Participant has definite plans to travel to a dengue endemic area during the study
- Refusal to allow storage of specimens for future research
- Other Treatment and Ongoing Exclusion Criteria:
- The following criteria will be reviewed on Study Days 28 and 56 following each vaccination. If any become applicable during the study, the participant will not be included in further immunogenicity evaluations, as of the exclusionary visit. The participant will, however, be encouraged to remain in the study for safety evaluations for the duration of the study.
- 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 any 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
Burlington, Vermont, 05405
About this study
Official title: A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
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 ability of a single dose of a trivalent dengue vaccine to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6 months after the trivalent dengue vaccine.
Read the detailed description
There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each capable of causing dengue illness ranging from a mild illness to life-threatening disease. This study will evaluate a trivalent live attenuated dengue admixture vaccine that contains 3 different monovalent dengue vaccine candidates, representing 3 of the 4 dengue serotypes (DENV-1, DENV-3, and DENV-4). Study researchers will evaluate the safety and protective efficacy of a single dose of the trivalent dengue vaccine against viremia and rash induced by infection with an attenuated DENV-2 virus (rDEN2Δ30-7169), administered 6 months after the trivalent dengue vaccine.
This study will enroll healthy adults with no history of previous flavivirus infection. At Day 0 (study entry), participants will be randomly assigned to receive either the trivalent dengue vaccine admixture or placebo. On Day 180, all participants will receive the rDEN2Δ30-7169 vaccine. Study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 180, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Visits will include physical examinations and blood collection. All participants will record their temperature 3 times a day for 16 days after each vaccination.
- Conditions
- Dengue
- Being tested
- Recombinant live attenuated trivalent dengue vaccine, Placebo, rDEN2Δ30-7169 vaccine
- 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.
Recombinant live attenuated trivalent dengue vaccineBiological
Contains 10^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10^3.3 PFU/mL of rDEN3Δ30/31-7164 and 10^3.3 PFU/mL of rDEN4Δ30. It is administered in 0.5 mL containing 10^3.0 PFU of each component.
PlaceboBiological
rDEN2Δ30-7169 vaccineBiological
Live recombinant attenuated DENV-2 candidate vaccine virus; will be administered at a dose of 10^3 PFU
| Study group | Role | What they receive |
|---|---|---|
| Trivalent dengue vaccine admixture + rDEN2Δ30-7169 | Experimental | Participants will receive the trivalent dengue vaccine admixture at Day 0 and the rDEN2Δ30-7169 vaccine at Day 180. Receives: Biological: Recombinant live attenuated trivalent dengue vaccine; Biological: rDEN2Δ30-7169 vaccine |
| Placebo + rDEN2Δ30-7169 | Experimental | Participants will receive a placebo vaccine at Day 0 and the rDEN2Δ30-7169 vaccine at Day 180. Receives: Biological: Placebo; Biological: rDEN2Δ30-7169 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of trivalent dengue vaccine admixture and rDEN2Δ30-7169-related adverse events (AEs)
Classified by both severity and seriousness, through active and passive surveillance.
Measured: Measured through Day 360
Dengue virus neutralizing antibody titers (measured through blood collection)
Measured: Measured through Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startSep 2015
- Primary completionNov 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
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anna Durbin, MD, Principal investigator, Center for Immunization Research (CIR), Johns Hopkins School of Public HealthKristen Pierce, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433652
- Sponsor's protocol ID
- CIR 300
- Status last verified
- Feb 2018
- First submitted
- 27 Apr 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
- ClinicalTrials.gov ID
- NCT02433652
- Acronym / sponsor ID
- CIR 300
- Conditions
- Dengue
- Keywords
- Dengue Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (actual)
- First posted
- 5 May 2015 (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 ability of a single dose of a trivalent dengue vaccine to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6 months after the trivalent dengue vaccine.
Detailed description
There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each capable of causing dengue illness ranging from a mild illness to life-threatening disease. This study will evaluate a trivalent live attenuated dengue admixture vaccine that contains 3 different monovalent dengue vaccine candidates, representing 3 of the 4 dengue serotypes (DENV-1, DENV-3, and DENV-4). Study researchers will evaluate the safety and protective efficacy of a single dose of the trivalent dengue vaccine against viremia and rash induced by infection with an attenuated DENV-2 virus (rDEN2Δ30-7169), administered 6 months after the trivalent dengue vaccine.
This study will enroll healthy adults with no history of previous flavivirus infection. At Day 0 (study entry), participants will be randomly assigned to receive either the trivalent dengue vaccine admixture or placebo. On Day 180, all participants will receive the rDEN2Δ30-7169 vaccine. Study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 180, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Visits will include physical examinations and blood collection. All participants will record their temperature 3 times a day for 16 days after each vaccination.
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 |
|---|---|---|
| Trivalent dengue vaccine admixture + rDEN2Δ30-7169 | Experimental | Biological: Recombinant live attenuated trivalent dengue vaccine, Biological: rDEN2Δ30-7169 vaccineParticipants will receive the trivalent dengue vaccine admixture at Day 0 and the rDEN2Δ30-7169 vaccine at Day 180. |
| Placebo + rDEN2Δ30-7169 | Experimental | Biological: Placebo, Biological: rDEN2Δ30-7169 vaccineParticipants will receive a placebo vaccine at Day 0 and the rDEN2Δ30-7169 vaccine at Day 180. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 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-second vaccination
- Willingness to participate in the study as evidenced by signing the informed consent document
- Females Only: Female participants of childbearing potential willing to use effective contraception. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, abstinence (6 months or longer since last sexual encounter). All female participants will be considered having child-bearing 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.
Key exclusion criteria (49 listed)
- Females Only: Currently pregnant, as determined by positive beta-human choriogonadotropin (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, psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the requirements of the study protocol
- Screening laboratory values of Grade 1 or above for absolute neutrophil (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol
- Any condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial 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 |
|---|---|---|
| Recombinant live attenuated trivalent dengue vaccineContains 10^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10^3.3 PFU/mL of rDEN3Δ30/31-7164 and 10^3.3 PFU/mL of rDEN4Δ30. It is administered in 0.5 mL containing 10^3.0 PFU of each component. | Biological | Trivalent dengue vaccine admixture + rDEN2Δ30-7169 |
| Placebo | Biological | Placebo + rDEN2Δ30-7169 |
| rDEN2Δ30-7169 vaccineLive recombinant attenuated DENV-2 candidate vaccine virus; will be administered at a dose of 10^3 PFU | Biological | Placebo + rDEN2Δ30-7169, Trivalent dengue vaccine admixture + rDEN2Δ30-7169 |
Primary outcome
Frequency of trivalent dengue vaccine admixture and rDEN2Δ30-7169-related adverse events (AEs)
Time frame: Measured through Day 360
Classified by both severity and seriousness, through active and passive surveillance.
Dengue virus neutralizing antibody titers (measured through blood collection)
Time frame: Measured through Day 360
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 28 Feb 2018.
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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
Center for Immunization Research (CIR), Johns Hopkins School of Public Health
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 Recombinant live attenuated trivalent dengue vaccine and rDEN2Δ30-7169 vaccine 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 8 inclusion and 49 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 28 Feb 2018. 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. 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 trivalent dengue vaccine admixture and rDEN2Δ30-7169-related adverse events (AEs) (time frame: Measured through Day 360). 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 28 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.