DenguePhase 1NCT02392325
Evaluating the Clinical and Immune Response to Two Dengue Virus Vaccines in Healthy Adults
A Phase 1 study testing rDEN1Δ30 and rDEN2Δ30-7169 in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Dengue viruses infect millions of people throughout the tropics and subtropics each year. The development of a dengue vaccine is an important health priority. This study will evaluate the immunologic and clinical response to two dengue vaccines, given 9 months apart, in healthy adults with no history of previous… 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?
- rDEN1Δ30 and rDEN2Δ30-7169
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Feb 2017
- 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 inoculation
- Willingness to reside in the inpatient unit for 10 days following receipt of rDEN2Δ30-7169
- 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, and abstinence (greater than or equal to 6 months 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.
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- 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
- Willingness to reside in the inpatient unit for 10 days following receipt of rDEN2Δ30-1769
- 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 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 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, 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
- Evidence of recent opiate use based on urine toxicology screen
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol
- 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
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- Any significant alcohol or drug abuse in the past 12 months which 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
- 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 antiplatelet medication such as aspirin or non-steroidal anti-inflammatory medication is permitted and will not exclude a participant from enrollment)
- 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 each vaccination
- History or serologic evidence of previous DENV 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 investigational)
- Anticipated receipt of any investigational agent in the 28 days before or after each vaccination
- Participant has definite plans to travel to a dengue endemic area during the study
- Inability to comply with the inpatient stay following the second DENV infection
- Refusal to allow storage of specimens for future research
- Anaphylaxis or angioedema following the first dose of vaccine
- Females Only: Currently pregnant, as determined by positive beta-HCG test, 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
- 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
- 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 antiplatelet medication such as aspirin or non-steroidal anti-inflammatory medication is permitted and will not exclude a participant from enrollment)
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 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.
- 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
- Refusal to allow storage of specimens for future research
- Other Treatments 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 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
Center for Immunization Research, Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Evaluation of the Clinical and Immune Response Generated by Heterologous Attenuated Dengue Virus Infection
Dengue viruses infect millions of people throughout the tropics and subtropics each year. The development of a dengue vaccine is an important health priority. This study will evaluate the immunologic and clinical response to two dengue vaccines, given 9 months apart, in healthy adults with no history of previous flavivirus infection.
Read the detailed description
Dengue is a mosquito-borne flavivirus. There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each of which can cause mild illness to life-threatening disease. The purpose of this study is to evaluate the immunologic and clinical response to two dengue vaccines (rDEN1Δ30 and rDEN2Δ30-7169), given 9 months apart, in healthy adults with no history of previous flavivirus infection.
Participants will be randomly assigned to receive the rDEN1Δ30 vaccine or a placebo vaccine at Day 0. Additional study visits will occur at Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 180, and 240. At Day 270, all participants will receive the rDEN2Δ30-7169 vaccine. An inpatient (overnight) stay will occur on Days 274 through 284, with participants being discharged on Day 284, if they meet the study criteria. Additional visits will occur at Days 286, 291, 298, 326, 360, and 450. Study visits will include blood collection and a physical examination. Participants will monitor and record their temperature 3 times a day for several days after each vaccination.
- Conditions
- Dengue
- Being tested
- rDEN1Δ30, Placebo, rDEN2Δ30-7169
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rDEN1Δ30Biological
Administered subcutaneously in 0.5 mL containing 10^3.0 plaque-forming units (PFU)
PlaceboBiological
Administered subcutaneously in 0.5 mL
rDEN2Δ30-7169Biological
Administered subcutaneously in 0.5 mL containing 10^3.0 PFU
| Study group | Role | What they receive |
|---|---|---|
| rDEN1Δ30 and rDEN2Δ30-7169 | Experimental | Participants will receive the rDEN1Δ30 vaccine at Day 0. They will receive the rDEN2Δ30-7169 vaccine at Day 270. Receives: Biological: rDEN1Δ30; Biological: rDEN2Δ30-7169 |
| Placebo and rDEN2Δ30-7169 | Experimental | Participants will receive placebo vaccine at Day 0. They will receive the rDEN2Δ30-7169 vaccine at Day 270. Receives: Biological: Placebo; Biological: rDEN2Δ30-7169 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of PRNT50 (plaque reduction neutralization titer) to DENV-1, DENV-2, DENV-3, and DENV-4
Measured: Measured through Day 90 post-vaccination
Incidence of solicited adverse events (AEs) following administration of rDEN2Δ30-7169 at Day 270
Measured: Measured through Day 450
Intensity of solicited adverse events (AEs) following administration of rDEN2Δ30-7169 at Day 270
Measured: Measured through Day 450
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionFeb 2017
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
- 12 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 Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392325
- Sponsor's protocol ID
- CIR 302
- Status last verified
- Feb 2018
- First submitted
- 2 Mar 2015
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Immune Response Generated by Heterologous Attenuated Dengue Virus Infection
- ClinicalTrials.gov ID
- NCT02392325
- Acronym / sponsor ID
- CIR 302
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 18 Mar 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.
Dengue viruses infect millions of people throughout the tropics and subtropics each year. The development of a dengue vaccine is an important health priority. This study will evaluate the immunologic and clinical response to two dengue vaccines, given 9 months apart, in healthy adults with no history of previous flavivirus infection.
Detailed description
Dengue is a mosquito-borne flavivirus. There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each of which can cause mild illness to life-threatening disease. The purpose of this study is to evaluate the immunologic and clinical response to two dengue vaccines (rDEN1Δ30 and rDEN2Δ30-7169), given 9 months apart, in healthy adults with no history of previous flavivirus infection.
Participants will be randomly assigned to receive the rDEN1Δ30 vaccine or a placebo vaccine at Day 0. Additional study visits will occur at Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 180, and 240. At Day 270, all participants will receive the rDEN2Δ30-7169 vaccine. An inpatient (overnight) stay will occur on Days 274 through 284, with participants being discharged on Day 284, if they meet the study criteria. Additional visits will occur at Days 286, 291, 298, 326, 360, and 450. Study visits will include blood collection and a physical examination. Participants will monitor and record their temperature 3 times a day for several 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 |
|---|---|---|
| rDEN1Δ30 and rDEN2Δ30-7169 | Experimental | Biological: rDEN1Δ30, Biological: rDEN2Δ30-7169Participants will receive the rDEN1Δ30 vaccine at Day 0. They will receive the rDEN2Δ30-7169 vaccine at Day 270. |
| Placebo and rDEN2Δ30-7169 | Experimental | Biological: Placebo, Biological: rDEN2Δ30-7169Participants will receive placebo vaccine at Day 0. They will receive the rDEN2Δ30-7169 vaccine at Day 270. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 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 inoculation
- Willingness to reside in the inpatient unit for 10 days following receipt of rDEN2Δ30-7169
- Willingness to participate in the study as evidenced by signing the informed consent document
Key exclusion criteria (49 listed)
- Females Only: Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test, 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
- Evidence of recent opiate use based on urine toxicology screen
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this 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 |
|---|---|---|
| rDEN1Δ30Administered subcutaneously in 0.5 mL containing 10^3.0 plaque-forming units (PFU) | Biological | rDEN1Δ30 and rDEN2Δ30-7169 |
| PlaceboAdministered subcutaneously in 0.5 mL | Biological | Placebo and rDEN2Δ30-7169 |
| rDEN2Δ30-7169Administered subcutaneously in 0.5 mL containing 10^3.0 PFU | Biological | Placebo and rDEN2Δ30-7169, rDEN1Δ30 and rDEN2Δ30-7169 |
Primary outcome
Measurement of PRNT50 (plaque reduction neutralization titer) to DENV-1, DENV-2, DENV-3, and DENV-4
Time frame: Measured through Day 90 post-vaccination
Incidence of solicited adverse events (AEs) following administration of rDEN2Δ30-7169 at Day 270
Time frame: Measured through Day 450
Intensity of solicited adverse events (AEs) following administration of rDEN2Δ30-7169 at Day 270
Time frame: Measured through Day 450
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 8 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
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 rDEN1Δ30 and rDEN2Δ30-7169 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 11 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 8 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 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?
Measurement of PRNT50 (plaque reduction neutralization titer) to DENV-1, DENV-2, DENV-3, and DENV-4 (time frame: Measured through Day 90 post-vaccination). 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 8 Feb 2018.