DenguePhase 1NCT01931176
Evaluating the Safety and Immune Response to a Dengue Virus Vaccine in Healthy Adults
A Phase 1 study testing rDEN2Δ30-7169 vaccine in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Dengue viruses can cause dengue fever and other more serious illnesses. The purpose of this study is to evaluate the safety and immune response to a dengue virus vaccine. 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?
- rDEN2Δ30-7169 vaccine
- 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
- 1 siteUnited States
- Study dates
- Jun 2013to May 2015
- 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
- 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 to participate in the study as evidenced by signing the informed consent document
- Female participants of childbearing potential willing to use effective contraception for the duration of the trial. More information on this criterion can be found in the protocol.
Who cannot join
- 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 participant 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 the 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 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 which has caused medical, occupational, or family problems, as indicated by participant history
Show all 30Show fewer
- 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, 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
- Has definite plans to travel to a dengue endemic area during the study
- 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 following 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.
- 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
1 site in 1 country.
United States1 site
John Hopkins Bloomberg School of Public Health - Center for Immunization Research (CIR)
Baltimore, Maryland, 21205
About this study
Official title: A Phase 1 Evaluation of the Safety and Immunogenicity of rDEN2Δ30-7169, a Live Attenuated Monovalent Dengue Virus Vaccine
Dengue viruses can cause dengue fever and other more serious illnesses. The purpose of this study is to evaluate the safety and immune response to a dengue virus vaccine.
Read the detailed description
Dengue viruses can cause dengue fever and the more severe disease, dengue hemorrhagic fever/shock syndrome (DHF/DSS). Infection with dengue viruses is the leading cause of hospitalization and death in children in at least 8 tropical Asian countries. There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each of which can cause dengue illness ranging from a mild illness to life-threatening disease. This study will evaluate the experimental rDEN2Δ30-7169 vaccine for the prevention of illness due to DENV-2. The purpose of this study is to evaluate the safety and immunogenicity of this vaccine in healthy adults with no history of previous flavivirus infection.
At study entry, participants will be randomly assigned to receive either the dengue virus vaccine or placebo. They will remain in the clinic for 30 minutes after receiving the injection for monitoring. Study visits will occur at Days 2, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, and 180. All study visits will include a blood collection, and most study visits will include a physical examination. Female participants will have a pregnancy test at select visits. Participants will record their temperature at least 3 times a day for the first 16 days; study researchers will review these readings during the study visits.
- Conditions
- Dengue
- Being tested
- rDEN2Δ30-7169 vaccine, Placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rDEN2Δ30-7169 vaccineBiological
Administered at a dose of 10^3 plaque-forming units (PFU); delivered by subcutaneous injection in the deltoid region of the upper arm
PlaceboBiological
Delivered by subcutaneous injection in the deltoid region of the upper arm
| Study group | Role | What they receive |
|---|---|---|
| rDEN2Δ30-7169 vaccine | Experimental | Participants will receive a single injection of the rDEN2Δ30-7169 vaccine at study entry. Receives: Biological: rDEN2Δ30-7169 vaccine |
| Placebo | Placebo comparator | Participants will receive a single injection of placebo at study entry. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of rDEN2Δ30-7169 vaccine as assessed by the frequency of vaccine-related adverse events (AEs)
AEs are classified by both severity and seriousness, through active and passive surveillance.
Measured: Measured through participants' last study visit at Day 180
Frequency, quantity, and duration of viremia following vaccination
Subjects will have samples assayed for vaccine virus on Study Days 0, 2, 4, 6, 8, 10, 12, 14, and 16. Serum will be serially diluted and the titer of vaccine virus determined.
Measured: Measured through participants' last study visit at Day 180
Immune response of the vaccine at 4 and 8 weeks post-vaccination
Seropositivity to DENV-2 is defined as PRNT50 ≥ 1:10. Seroconversion is defined as a ≥ 4-fold rise in PRNT50 to wt DENV-2 Tonga/74 by Study Day 56.
Measured: Measured at 4 and 8 weeks post-vaccination
Titer of virus vaccine
The peak titer, day of onset, and duration of viremia will be calculated for each subject within the vaccinated group.
Measured: Measured through participants' last study visit at Day 180
Number of vaccinees who seroconvert to DENV-2 by study Day 56
Seroconversion will be defined as a ≥ 4-fold rise in PRNT50 to wt DENV-2 Tonga/74 by Study Day 56.
Measured: Measured through Day 56
Secondary outcomes (3)
Number of vaccinees infected with rDEN2Δ30-7169 vaccine
Infection is defined as recovery of vaccine virus from the blood or serum of a subject and/or by seroconversion to DENV-2 defined as a ≥ 4-fold rise in DENV-2 neutralizing antibody titers by Study Day 56 when compared with Study Day 0.
Measured: Measured through participants' last study visit at Day 180
Comparison of infectivity rates, safety, and immunogenicity of a single dose of rDEN2Δ30 vaccine with the reported infectivity and safety of rDEN2/4Δ30 from previous clinical trials
Measured: Measured through participants' last study visit at Day 180
Durability of neutralizing antibody by measuring serum neutralizing antibody to DENV-2 out to 180 days after vaccination
Measured: Measured through participants' last study visit at Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Anna Durbin, MD, Principal investigator, Center for Immunization Research (CIR), Johns Hopkins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931176
- Sponsor's protocol ID
- CIR 286
- Other IDs
- CIR 286
- Status last verified
- Dec 2015
- First submitted
- 26 Aug 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larsen CP, Whitehead SS, Durbin AP. Dengue human infection models to advance dengue vaccine development. Vaccine. 2015 Dec 10;33(50):7075-82. doi: 10.1016/j.vaccine.2015.09.052. Epub 2015 Sep 28.
PubMed 26424605
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. 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 rDEN2Δ30-7169, a Live Attenuated Monovalent Dengue Virus Vaccine
- ClinicalTrials.gov ID
- NCT01931176
- Acronym / sponsor ID
- CIR 286
- Conditions
- Dengue
- 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
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Aug 2013 (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 more serious illnesses. The purpose of this study is to evaluate the safety and immune response to a dengue virus vaccine.
Detailed description
Dengue viruses can cause dengue fever and the more severe disease, dengue hemorrhagic fever/shock syndrome (DHF/DSS). Infection with dengue viruses is the leading cause of hospitalization and death in children in at least 8 tropical Asian countries. There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each of which can cause dengue illness ranging from a mild illness to life-threatening disease. This study will evaluate the experimental rDEN2Δ30-7169 vaccine for the prevention of illness due to DENV-2. The purpose of this study is to evaluate the safety and immunogenicity of this vaccine in healthy adults with no history of previous flavivirus infection.
At study entry, participants will be randomly assigned to receive either the dengue virus vaccine or placebo. They will remain in the clinic for 30 minutes after receiving the injection for monitoring. Study visits will occur at Days 2, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, and 180. All study visits will include a blood collection, and most study visits will include a physical examination. Female participants will have a pregnancy test at select visits. Participants will record their temperature at least 3 times a day for the first 16 days; study researchers will review these readings during the study visits.
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 |
|---|---|---|
| rDEN2Δ30-7169 vaccine | Experimental | Biological: rDEN2Δ30-7169 vaccineParticipants will receive a single injection of the rDEN2Δ30-7169 vaccine at study entry. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive a single injection of placebo at study entry. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 to participate in the study as evidenced by signing the informed consent document
- Female participants of childbearing potential willing to use effective contraception for the duration of the trial. More information on this criterion can be found in the protocol.
Key exclusion criteria (30 listed)
- 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 participant 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 the 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 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 |
|---|---|---|
| rDEN2Δ30-7169 vaccineAdministered at a dose of 10^3 plaque-forming units (PFU); delivered by subcutaneous injection in the deltoid region of the upper arm | Biological | rDEN2Δ30-7169 vaccine |
| PlaceboDelivered by subcutaneous injection in the deltoid region of the upper arm | Biological | Placebo |
Primary outcome
Safety of rDEN2Δ30-7169 vaccine as assessed by the frequency of vaccine-related adverse events (AEs)
Time frame: Measured through participants' last study visit at Day 180
AEs are classified by both severity and seriousness, through active and passive surveillance.
Frequency, quantity, and duration of viremia following vaccination
Time frame: Measured through participants' last study visit at Day 180
Subjects will have samples assayed for vaccine virus on Study Days 0, 2, 4, 6, 8, 10, 12, 14, and 16. Serum will be serially diluted and the titer of vaccine virus determined.
Immune response of the vaccine at 4 and 8 weeks post-vaccination
Time frame: Measured at 4 and 8 weeks post-vaccination
Seropositivity to DENV-2 is defined as PRNT50 ≥ 1:10. Seroconversion is defined as a ≥ 4-fold rise in PRNT50 to wt DENV-2 Tonga/74 by Study Day 56.
Titer of virus vaccine
Time frame: Measured through participants' last study visit at Day 180
The peak titer, day of onset, and duration of viremia will be calculated for each subject within the vaccinated group.
Number of vaccinees who seroconvert to DENV-2 by study Day 56
Time frame: Measured through Day 56
Seroconversion will be defined as a ≥ 4-fold rise in PRNT50 to wt DENV-2 Tonga/74 by Study Day 56.
3 secondary outcomes
Number of vaccinees infected with rDEN2Δ30-7169 vaccine
Time frame: Measured through participants' last study visit at Day 180
Comparison of infectivity rates, safety, and immunogenicity of a single dose of rDEN2Δ30 vaccine with the reported infectivity and safety of rDEN2/4Δ30 from previous clinical trials
Time frame: Measured through participants' last study visit at Day 180
Durability of neutralizing antibody by measuring serum neutralizing antibody to DENV-2 out to 180 days after vaccination
Time frame: Measured through participants' last study visit at 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 15 Dec 2015.
- Derived from this study: PubMed 26424605Larsen CP, Whitehead SS, Durbin AP. Dengue human infection models to advance dengue vaccine development. Vaccine. 2015 Dec 10;33(50):7075-82. doi: 10.1016/j.vaccine.2015.09.052. Epub 2015 Sep 28.
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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
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 rDEN2Δ30-7169 vaccine in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 30 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 15 Dec 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. 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?
Safety of rDEN2Δ30-7169 vaccine as assessed by the frequency of vaccine-related adverse events (AEs) (time frame: Measured through participants' last study visit at Day 180). The study lists 5 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 NCT01931176, which also lists 1 linked publication.
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 15 Dec 2015.