DenguePhase 1NCT03416036
Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge
A Phase 1 study testing TetraVax-DV-TV003 (TV003), rDEN2Δ30-7169 (DENV-2) and rDEN3Δ30 (DENV-3) in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50… 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?
- TetraVax-DV-TV003 (TV003), rDEN2Δ30-7169 (DENV-2) and rDEN3Δ30 (DENV-3)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Nov 2017to 4 Jun 2019
- 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, which is approximately 28 weeks.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Females only: Female subjects of childbearing potential should be willing to use effective contraception and have no plans to undergo IVF (in vitro fertilization) during participation in 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 with a male). All female subjects will be considered as having childbearing potential, except for those who have had a hysterectomy, tubal ligation, or tubal coil (at least 3 months prior to vaccination), or are considered to be post-menopausal, as documented by at least 1 year since last menstrual period.
Who cannot join
- Females only: Currently pregnant, as determined by positive β-human choriogonadotropin (HCG) test, or breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.
- 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 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, as indicated by screening and confirmatory assays.
- Hepatitis C virus (HCV) infection, as indicated by screening and confirmatory assays.
- Hepatitis B virus (HBV) infection, as indicated by hepatitis B surface antigen (HBsAg) screening.
- Any known immunodeficiency syndrome.
- Current use of anticoagulant medications (this does not include anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg of a 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 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). Subjects will also be screened for Zika virus if they have traveled to areas of South and Central America in the past 18 months that have reported Zika-virus transmission (per the Centers for Disease Control and Prevention Zika travel information).
- Previous receipt of a flavivirus vaccine (licensed or experimental).
- Anticipated receipt of any investigational agent in the 28 days before or after vaccination.
- Definite plans to travel to a dengue-endemic area during the study.
- Refusal to allow specimen storage for future research.
- Inclusion Criteria for Challenge with rDEN2Δ30-7169 or rDEN3Δ30
- Currently enrolled in the study.
- Good general health as determined by physical examination and review of medical history.
- Available for the duration of the study, which is approximately 24 weeks after challenge.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Females only: Female subjects of childbearing potential should be 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 subjects will be considered as having childbearing potential, except for those who have had a hysterectomy, tubal ligation, or tubal coil (at least 3 months prior to vaccination), or who are considered to be post-menopausal, as documented by at least 1 year since last menstrual period.
- Anaphylaxis or angioedema following TV003 administration.
- Females only: Currently pregnant, as determined by positive β- HCG test, or breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability 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 subject participating in the trial, or would render the subject unable to comply with the protocol.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma (emergency room visit or hospitalization within the last 6 months).
- Any known immunodeficiency syndrome.
- Current use of anticoagulant medications (this does not include anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following challenge. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg of a prednisone equivalent per day for greater than or equal to 14 days.
- Receipt of a live vaccine (other than TV003) within 28 days prior to challenge or the anticipated receipt of a live vaccine within 28 days after challenge.
- Receipt of a killed vaccine within 14 days prior to challenge or anticipated receipt of a killed vaccine within 14 days following challenge.
- 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 challenge.
- Anticipated receipt of any other investigational agent in the 28 days before or after challenge.
- Definite plans to travel to a dengue-endemic area during the study.
- Refusal to allow specimen storage for future research.
- Other Treatments and Ongoing Exclusion Criteria:
- The following criteria will be reviewed on study day 28 following receipt of TV003 and at study days 28 and 56 following receipt of rDEN2Δ30-7169 or rDEN3Δ30. If any become applicable during the study, the subject will not be included in per-protocol immunogenicity evaluations, as of the exclusionary visit. The subject will, however, be encouraged to remain in the study for safety evaluations until 6 months following the last vaccination (or challenge) received. If the subject had samples obtained at one or more of the protocol-defined time points for immunogenicity, he/she will be included in the intention-to-treat immunogenicity analysis.
- Use of any investigational drug or investigational vaccine other than the study vaccine during the 28-day post-inoculation period.
- Chronic administration (greater than or equal to 14 days) of steroids (defined as a 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-inoculation (topical and nasal steroids are allowed).
- Receipt of a licensed killed vaccine during the 14-day post-inoculation period.
- Receipt of immunoglobulins and/or any blood products during the 28-day post-inoculation period.
- Pregnancy (see clarifying language in the protocol) - If the pregnancy is terminated spontaneously or by therapeutic abortion, immunogenicity assessments will be done on blood samples obtained after the pregnancy is terminated.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
Vaccine Testing Center, University of Vermont
Burlington, Vermont, 05405
About this study
The purpose of this study is to evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.
Read the detailed description
This study will evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.
Participants will be randomly assigned to receive either TV003 or placebo at study entry (Day 0) and either rDEN2Δ30-7169 or rDEN3Δ30 on Day 28.
Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 32, 34, 36, 38, 40, 42, 44, 49, 56, 84, 118, and 208. Visits may include a physical examination and blood collection.
- Conditions
- Dengue
- Being tested
- TetraVax-DV-TV003 (TV003), rDEN2Δ30-7169 (DENV-2), rDEN3Δ30 (DENV-3), Placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraVax-DV-TV003 (TV003)Biological
TV003 contains 10^3.3 plaque-forming units (PFU)/mL of rDEN1Δ30, 10^3.3 PFU/mL of rDEN2/4Δ30(ME), 10^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10^3.3 PFU/mL of rDEN4Δ30. Administered by subcutaneous injection in the deltoid region of the upper arm
rDEN2Δ30-7169 (DENV-2)Biological
Administered at a dose of 10^3 PFU by subcutaneous injection in the deltoid region of the upper arm
rDEN3Δ30 (DENV-3)Biological
Administered at a dose of 10^3 PFU 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 |
|---|---|---|
| Arm 1: TV003 + rDEN2Δ30-7169 | Experimental | Participants will receive a single dose of TV003 at study entry (Day 0) and rDEN2Δ30-7169 on Day 28. Receives: Biological: TetraVax-DV-TV003 (TV003); Biological: rDEN2Δ30-7169 (DENV-2) |
| Arm 2: TV003 + rDEN3Δ30 | Experimental | Participants will receive a single dose of TV003 at study entry (Day 0) and rDEN3Δ30 on Day 28. Receives: Biological: TetraVax-DV-TV003 (TV003); Biological: rDEN3Δ30 (DENV-3) |
| Arm 3: Placebo + rDEN2Δ30-7169 | Placebo comparator | Participants will receive placebo at study entry (Day 0) and rDEN2Δ30-7169 on Day 28. Receives: Biological: rDEN2Δ30-7169 (DENV-2); Biological: Placebo |
| Arm 4: Placebo + rDEN3Δ30 | Placebo comparator | Participants will receive placebo at study entry (Day 0) and rDEN3Δ30 on Day 28. Receives: Biological: rDEN3Δ30 (DENV-3); Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of rDEN2Δ30-7160 viremia
Based on statistical analysis of laboratory evaluations
Measured: Measured through Month 1
Frequency of rDEN3Δ30 viremia
Based on statistical analysis of laboratory evaluations
Measured: Measured through Month 1
Occurrence of solicited local and general adverse events (AEs)
Evaluated using the Adverse Event Grading Table in the study protocol
Measured: Measured through Day 56
Occurrence of unsolicited AEs
Evaluated using the Adverse Event Grading Table in the study protocol
Measured: Measured through Day 56
Occurrence of serious adverse events (SAEs)
Evaluated using the Adverse Event Grading Table in the study protocol
Measured: Measured through Day 208
Secondary outcomes (3)
Frequency of viremia after vaccination with TV003
Based on statistical analysis of laboratory evaluations
Measured: Measured through Day 208
Number of TV003 recipients infected with vaccine virus DENV-1, DENV-2, DENV-3, and DENV-4
As defined by recovery of vaccine virus from the blood or serum of a subject and/or seropositivity OR seroconversion to DENV
Measured: Measured through Day 208
Serum plaque reduction neutralization titer 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses
Determined by seropositivity and seroconversion frequencies
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 posted30 Jan 2018
- Study start28 Nov 2017
- Primary completion17 Jan 2019
- Study completion4 Jun 2019
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
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anna Durbin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416036
- Sponsor's protocol ID
- CIR 323
- Status last verified
- Jan 2020
- First submitted
- 24 Jan 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kirkpatrick BD, Whitehead SS, Pierce KK, Tibery CM, Grier PL, Hynes NA, Larsson CJ, Sabundayo BP, Talaat KR, Janiak A, Carmolli MP, Luke CJ, Diehl SA, Durbin AP. The live attenuated dengue vaccine TV003 elicits complete protection against dengue in a human challenge model. Sci Transl Med. 2016 Mar 16;8(330):330ra36. doi: 10.1126/scitranslmed.aaf1517. Epub 2016 Mar 16.
PubMed 27089205
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge
- ClinicalTrials.gov ID
- NCT03416036
- Acronym / sponsor ID
- CIR 323
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 30 Jan 2018 (actual)
- 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.
The purpose of this study is to evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.
Detailed description
This study will evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.
Participants will be randomly assigned to receive either TV003 or placebo at study entry (Day 0) and either rDEN2Δ30-7169 or rDEN3Δ30 on Day 28.
Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 32, 34, 36, 38, 40, 42, 44, 49, 56, 84, 118, and 208. Visits may include a physical examination and blood collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: TV003 + rDEN2Δ30-7169 | Experimental | Biological: TetraVax-DV-TV003 (TV003), Biological: rDEN2Δ30-7169 (DENV-2)Participants will receive a single dose of TV003 at study entry (Day 0) and rDEN2Δ30-7169 on Day 28. |
| Arm 2: TV003 + rDEN3Δ30 | Experimental | Biological: TetraVax-DV-TV003 (TV003), Biological: rDEN3Δ30 (DENV-3)Participants will receive a single dose of TV003 at study entry (Day 0) and rDEN3Δ30 on Day 28. |
| Arm 3: Placebo + rDEN2Δ30-7169 | Placebo comparator | Biological: rDEN2Δ30-7169 (DENV-2), Biological: PlaceboParticipants will receive placebo at study entry (Day 0) and rDEN2Δ30-7169 on Day 28. |
| Arm 4: Placebo + rDEN3Δ30 | Placebo comparator | Biological: rDEN3Δ30 (DENV-3), Biological: PlaceboParticipants will receive placebo at study entry (Day 0) and rDEN3Δ30 on Day 28. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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, which is approximately 28 weeks.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Females only: Female subjects of childbearing potential should be willing to use effective contraception and have no plans to undergo IVF (in vitro fertilization) during participation in 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 with a male). All female subjects will be considered as having childbearing potential, except for those who have had a hysterectomy, tubal ligation, or tubal coil (at least 3 months prior to vaccination), or are considered to be post-menopausal, as documented by at least 1 year since last menstrual period.
Key exclusion criteria (52 listed)
- Females only: Currently pregnant, as determined by positive β-human choriogonadotropin (HCG) test, or breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.
- 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 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 |
|---|---|---|
| TetraVax-DV-TV003 (TV003)TV003 contains 10^3.3 plaque-forming units (PFU)/mL of rDEN1Δ30, 10^3.3 PFU/mL of rDEN2/4Δ30(ME), 10^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10^3.3 PFU/mL of rDEN4Δ30. Administered by subcutaneous injection in the deltoid region of the upper arm | Biological | Arm 1: TV003 + rDEN2Δ30-7169, Arm 2: TV003 + rDEN3Δ30 |
| rDEN2Δ30-7169 (DENV-2)Administered at a dose of 10^3 PFU by subcutaneous injection in the deltoid region of the upper arm | Biological | Arm 1: TV003 + rDEN2Δ30-7169, Arm 3: Placebo + rDEN2Δ30-7169 |
| rDEN3Δ30 (DENV-3)Administered at a dose of 10^3 PFU by subcutaneous injection in the deltoid region of the upper arm | Biological | Arm 2: TV003 + rDEN3Δ30, Arm 4: Placebo + rDEN3Δ30 |
| PlaceboAdministered by subcutaneous injection in the deltoid region of the upper arm | Biological | Arm 3: Placebo + rDEN2Δ30-7169, Arm 4: Placebo + rDEN3Δ30 |
Primary outcome
Frequency of rDEN2Δ30-7160 viremia
Time frame: Measured through Month 1
Based on statistical analysis of laboratory evaluations
Frequency of rDEN3Δ30 viremia
Time frame: Measured through Month 1
Based on statistical analysis of laboratory evaluations
Occurrence of solicited local and general adverse events (AEs)
Time frame: Measured through Day 56
Evaluated using the Adverse Event Grading Table in the study protocol
Occurrence of unsolicited AEs
Time frame: Measured through Day 56
Evaluated using the Adverse Event Grading Table in the study protocol
Occurrence of serious adverse events (SAEs)
Time frame: Measured through Day 208
Evaluated using the Adverse Event Grading Table in the study protocol
3 secondary outcomes
Frequency of viremia after vaccination with TV003
Time frame: Measured through Day 208
Number of TV003 recipients infected with vaccine virus DENV-1, DENV-2, DENV-3, and DENV-4
Time frame: Measured through Day 208
Serum plaque reduction neutralization titer 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses
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 18 Jan 2020.
- Background: PubMed 27089205Kirkpatrick BD, Whitehead SS, Pierce KK, Tibery CM, Grier PL, Hynes NA, Larsson CJ, Sabundayo BP, Talaat KR, Janiak A, Carmolli MP, Luke CJ, Diehl SA, Durbin AP. The live attenuated dengue vaccine TV003 elicits complete protection against dengue in a human challenge model. Sci Transl Med. 2016 Mar 16;8(330):330ra36. doi: 10.1126/scitranslmed.aaf1517. Epub 2016 Mar 16.
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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
Johns Hopkins Bloomberg School of Public Health
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 TetraVax-DV-TV003 (TV003), rDEN2Δ30-7169 (DENV-2) and rDEN3Δ30 (DENV-3) 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 5 inclusion and 52 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 18 Jan 2020. 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 rDEN2Δ30-7160 viremia (time frame: Measured through Month 1). 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 NCT03416036, 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 18 Jan 2020.