DenguePhase 1NCT02873260
Evaluating the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30
A Phase 1 study testing TetraVax-DV-TV005 and rDEN3Δ30 in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This study will evaluate the ability of a single dose of the live attenuated recombinant tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005 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?
- TetraVax-DV-TV005 and rDEN3Δ30
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to Nov 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 participate in the study as evidenced by signing the informed consent document.
- Females Only: Female subjects 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 subjects 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.
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- Available for the duration of the study, approximately 26 weeks after the second dose.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Females Only: Female subjects of childbearing potential willing to use effective contraception for the duration of the trial. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (greater than or equal to 6 months since last sexual encounter). All female subjects will be considered having 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 β-human choriogonadotropin (HCG) test, breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
- 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, 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.
- 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. 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). Subjects will also be screened for Zika virus if they have traveled in the past 18 months to areas of South \& Central America that have reported Zika-virus transmission (per Centers for Disease Control and Prevention [CDC] 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.
- Subject has definite plans to travel to a dengue endemic area during the study.
- Refusal to allow storage of specimens for future research.
- Anaphylaxis or angioedema following the TV005 administration.
- Females Only: Currently pregnant, as determined by positive β- HCG test, breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
- 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.
- 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.
- 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 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.
- 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.
- Anticipated receipt of any other investigational agent in the 28 days before or after vaccination.
- Subject 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 Study Days 28 and 56 following each vaccination. 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. The subject will have samples obtained at the protocol-defined time-points for immunogenicity and will be included in intention-to-treat immunogenicity analysis.
- 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 21-day period post vaccination.
- Receipt of immunoglobulins and/or any blood products during the 28-day period post-vaccination.
- 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 termination of the pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Immunization Research, Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
University of Vermont Testing Center
Burlington, Vermont, 05405
About this study
Official title: A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30
This study will evaluate the ability of a single dose of the live attenuated recombinant tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005 vaccine.
Read the detailed description
Dengue infection ranging from mild illness to life-threatening disease is widespread in most tropical and subtropical regions of the world. Infection with any of the four serotypes of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4) can cause dengue illness. TetraVax-DV-TV005 (referred to as TV005) is a live attenuated recombinant tetravalent dengue virus vaccine developed to protect against all four dengue virus serotypes. This study will evaluate the ability of a single dose of TV005 to protect against infection with rDEN3Δ30, a naturally attenuated DENV-3, given 6 months following vaccination with TV005.
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 TV005 vaccine or placebo. On Day 180, all participants will receive the rDEN3Δ30 virus. All participants will record their temperature 3 times a day for 16 days after each vaccination. Additional study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Study visits will include physical examinations and blood collection.
- Conditions
- Dengue
- Being tested
- TetraVax-DV-TV005, rDEN3Δ30, Placebo
- Keywords
- Dengue Vaccine
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraVax-DV-TV005Biological
Also called TV005
TetraVax-DV-TV005 contains 10^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10^4.3 PFU/mL of rDEN2/4Δ30(ME), 10^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10^3.3 PFU/mL of rDEN4Δ30. The vaccine is administered in 0.5 mL containing 10^3.0 PFU of each component with the exception of rDEN2/4Δ30 that is given at a dose of 10^4 PFU. TetraVax-DV-TV005 is administered by subcutaneous injection in the deltoid region of the upper arm.
rDEN3Δ30Biological
Administered at a dose of 10^4 PFU by subcutaneous injection in the deltoid region of the upper arm.
PlaceboBiological
Administered at a volume of 0.5 mL by subcutaneous injection in the deltoid region of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| TetraVax-DV-TV005 + rDEN3Δ30 | Experimental | Participants will receive the TetraVax-DV-TV005 vaccine at Day 0 and the rDEN3Δ30 virus at Day 180. Receives: Biological: TetraVax-DV-TV005; Biological: rDEN3Δ30 |
| Placebo + rDEN3Δ30 | Placebo comparator | Participants will receive placebo at Day 0 and the rDEN3Δ30 virus at Day 180. Receives: Biological: rDEN3Δ30; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of TV005 and rDEN3Δ30-related adverse events (AEs)
As classified by both severity and seriousness, through active and passive surveillance
Measured: Measured through Day 360
Frequency of viremia
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 posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2017
- Study completionNov 2017
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
- 48 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
- NCT02873260
- Sponsor's protocol ID
- CIR 309
- Status last verified
- Mar 2018
- First submitted
- 16 Aug 2016
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pierce KK, Durbin AP, Walsh MR, Carmolli M, Sabundayo BP, Dickson DM, Diehl SA, Whitehead SS, Kirkpatrick BD. TV005 dengue vaccine protects against dengue serotypes 2 and 3 in two controlled human infection studies. J Clin Invest. 2024 Feb 1;134(3):e173328. doi: 10.1172/JCI173328.
PubMed 37971871
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 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 the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30
- ClinicalTrials.gov ID
- NCT02873260
- Acronym / sponsor ID
- CIR 309
- Conditions
- Dengue
- Keywords
- Dengue Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the ability of a single dose of the live attenuated recombinant tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005 vaccine.
Detailed description
Dengue infection ranging from mild illness to life-threatening disease is widespread in most tropical and subtropical regions of the world. Infection with any of the four serotypes of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4) can cause dengue illness. TetraVax-DV-TV005 (referred to as TV005) is a live attenuated recombinant tetravalent dengue virus vaccine developed to protect against all four dengue virus serotypes. This study will evaluate the ability of a single dose of TV005 to protect against infection with rDEN3Δ30, a naturally attenuated DENV-3, given 6 months following vaccination with TV005.
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 TV005 vaccine or placebo. On Day 180, all participants will receive the rDEN3Δ30 virus. All participants will record their temperature 3 times a day for 16 days after each vaccination. Additional study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Study visits will include physical examinations 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
- 2
| Arm | Type | Receives |
|---|---|---|
| TetraVax-DV-TV005 + rDEN3Δ30 | Experimental | Biological: TetraVax-DV-TV005, Biological: rDEN3Δ30Participants will receive the TetraVax-DV-TV005 vaccine at Day 0 and the rDEN3Δ30 virus at Day 180. |
| Placebo + rDEN3Δ30 | Placebo comparator | Biological: rDEN3Δ30, Biological: PlaceboParticipants will receive placebo at Day 0 and the rDEN3Δ30 virus at Day 180. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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 participate in the study as evidenced by signing the informed consent document.
- Females Only: Female subjects 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 subjects 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 β-human choriogonadotropin (HCG) test, breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
- 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-TV005Also: TV005TetraVax-DV-TV005 contains 10^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10^4.3 PFU/mL of rDEN2/4Δ30(ME), 10^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10^3.3 PFU/mL of rDEN4Δ30. The vaccine is administered in 0.5 mL containing 10^3.0 PFU of each component with the exception of rDEN2/4Δ30 that is given at a dose of 10^4 PFU. TetraVax-DV-TV005 is administered by subcutaneous injection in the deltoid region of the upper arm. | Biological | TetraVax-DV-TV005 + rDEN3Δ30 |
| rDEN3Δ30Administered at a dose of 10^4 PFU by subcutaneous injection in the deltoid region of the upper arm. | Biological | Placebo + rDEN3Δ30, TetraVax-DV-TV005 + rDEN3Δ30 |
| PlaceboAdministered at a volume of 0.5 mL by subcutaneous injection in the deltoid region of the upper arm. | Biological | Placebo + rDEN3Δ30 |
Primary outcome
Frequency of TV005 and rDEN3Δ30-related adverse events (AEs)
Time frame: Measured through Day 360
As classified by both severity and seriousness, through active and passive surveillance
Frequency of viremia
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 8 Mar 2018.
- Derived from this study: PubMed 37971871Pierce KK, Durbin AP, Walsh MR, Carmolli M, Sabundayo BP, Dickson DM, Diehl SA, Whitehead SS, Kirkpatrick BD. TV005 dengue vaccine protects against dengue serotypes 2 and 3 in two controlled human infection studies. J Clin Invest. 2024 Feb 1;134(3):e173328. doi: 10.1172/JCI173328.
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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
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-TV005 and rDEN3Δ30 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 9 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 Mar 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. 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 TV005 and rDEN3Δ30-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?
On the ClinicalTrials.gov record for NCT02873260, 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 8 Mar 2018.