DenguePhase 1NCT01506570
Evaluating the Safety and Immune Response to Two Admixtures of a Tetravalent Dengue Virus Vaccine
A Phase 1 study testing TetraVax-DV Vaccine - Admixture TV003 and TetraVax-DV Vaccine - Admixture TV005 in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy adults who have previously been infected with a… 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 Vaccine - Admixture TV003 and TetraVax-DV Vaccine - Admixture TV005
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2011to Sep 2013
- 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
- In good general health, as determined by physical examination, laboratory screening, and review of medical history
- Documented history or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus [YFV], St. Louis encephalitis virus [SLE], West Nile virus [WNV], Japanese encephalitis virus [JEV], or tick-borne encephalitis virus [TBEV]) or documented previous receipt of a flavivirus vaccine (licensed or experimental)
- Available for the duration of the study, approximately 26 weeks post-second vaccination
- Willing to participate in the study as evidenced by signing the informed consent document
- Female participants of childbearing potential must be 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 choriogonadotropin (HCG) test, or breastfeeding
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, 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
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in the 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 12 months prior to study entry that has caused medical, occupational, or family problems, as indicated by a participant's history
Show all 52Show fewer
- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the 6 months prior to study entry)
- 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 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 42 days following vaccination
- Asplenia
- Receipt of blood products within the 6 months prior to study entry, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination
- Anticipated receipt of any investigational agent in the 42 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
- Additional Inclusion Criteria for Second Dose of Vaccine:
- In good general health, as determined by physical examination and review of medical history
- Available for the duration of the study, approximately 6 months post-vaccination
- Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial. More information on this criterion can be found in the protocol.
- Anaphylaxis or angioedema following the first dose of vaccine
- Currently pregnant, as determined by positive beta-HCG test, or breastfeeding
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, 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 12 months prior to study entry that has caused medical, occupational, or family problems, as indicated by a participant's history
- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the 6 months prior to study entry)
- HIV infection, by screening and confirmatory assays
- HCV infection, by screening and confirmatory assays
- HBV infection, by HBsAg screening
- Any known immunodeficiency syndrome
- Use of anticoagulant medications
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 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 42 days following vaccination
- Asplenia
- Receipt of blood products within the 6 months prior to study entry, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination
- Anticipated receipt of any other investigational agent in the 42 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 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.
- Ongoing Exclusion Criteria:
- Use of any investigational drug or investigational vaccine other than the study vaccine during the 42-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 42-day period post-vaccination (topical and nasal steroids are allowed)
- Receipt of a licensed vaccine during the 42-day period post-vaccination
- Receipt of immunoglobulins and/or any blood products during the 42-day period post-vaccination
- Pregnant
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for Immunization Research, Johns Hopkins School of Public Health
Baltimore, Maryland
Fletcher Allen Health Care (FAHC), General Clinical Research Center (GCRC)
Burlington, Vermont
University of Vermont Vaccine Testing Center
Burlington, Vermont
About this study
Official title: A Phase 1 Evaluation of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixtures TV003 and TV005 in Healthy Flavivirus-experienced Adult Subjects
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy adults who have previously been infected with a dengue virus or other flavivirus or have previously received a flavivirus vaccine.
Read the detailed description
Dengue viruses cause dengue fever and the more severe condition, dengue hemorrhagic fever/shock syndrome. Dengue viruses are common in most tropical and subtropical regions of the world and infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries. For these reasons, the World Health Organization (WHO) has made the development of a dengue virus vaccine a top priority. This study will evaluate the safety and immunogenicity of two doses of a live attenuated, tetravalent dengue virus vaccine called TetraVax-DV in healthy adults (18-50 years old) who have previously been infected with a dengue virus or other flavivirus or have previously received a flavivirus vaccine. Two different formulations of the TetraVax-DV vaccine will be evaluated.
Participants will be randomly assigned to receive one of two admixtures of the TetraVax-DV vaccine or a placebo. At a baseline study visit (Day 0), participants will undergo a medical history review, physical examination, blood collection, vital sign measurements, and a pregnancy test for females. Participants will then receive one subcutaneous (SC) injection of their assigned vaccine or placebo in the upper arm. After receiving the vaccine, participants will remain in the clinic for 30 minutes for observation and monitoring. At home, participants will monitor and record their temperature three times a day for 16 days after the first vaccination (from Day 0 through Day 16) and for 16 days after the second vaccination (from Day 180 through Day 196). Additional study visits will occur at Days 3, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 150 and will include a physical examination, vital sign measurements, and blood collection. On Day 180, participants will receive a second SC injection of their assigned vaccine or placebo. Additional study visits will then occur at Days 183, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360, and will include the same study procedures and monitoring that occurred after the first vaccination.
- Conditions
- Dengue
- Being tested
- TetraVax-DV Vaccine - Admixture TV003, TetraVax-DV Vaccine - Admixture TV005, 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 Vaccine - Admixture TV003Biological
One SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV003 (10^3 plaque-forming unit [PFU] of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30)
TetraVax-DV Vaccine - Admixture TV005Biological
One SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV005 (10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30)
PlaceboBiological
One SC injection at Day 0 and Day 180 of placebo
| Study group | Role | What they receive |
|---|---|---|
| TetraVax-DV Vaccine - Admixture TV003 | Experimental | Participants will receive one SC injection of the TetraVax-DV Vaccine - Admixture TV003 in their upper arm at Day 0 and Day 180. Receives: Biological: TetraVax-DV Vaccine - Admixture TV003 |
| TetraVax-DV Vaccine - Admixture TV005 | Experimental | Participants will receive one SC injection of the TetraVax-DV Vaccine - Admixture TV005 in their upper arm at Day 0 and Day 180. Receives: Biological: TetraVax-DV Vaccine - Admixture TV005 |
| Placebo | Placebo comparator | Participants will receive one SC injection of placebo in their upper arm at Day 0 and Day 180. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TetraVax-DV TV003 and TV005, as assessed by the frequency of vaccine-related adverse events
Measured: Measured through Day 360
Immunogenicity of TV003 and TV005, as assessed by neutralizing antibody titers to DENV-1, DENV-2, DENV-3, and DENV-4
Monovalent, bivalent, trivalent, and tetravalent seropositivity rates will be determined at 28, 56, and 90 days after each vaccination.
Measured: Measured 28, 56, 90, and 180 days after each vaccination
Whether a second dose of the vaccine given at Day 180 will induce seropositivity in those participants that remained seronegative to one or more DENV serotypes following the first vaccination
Measured: Measured through Day 360
Secondary outcomes (3)
Frequency, quantity, and duration of viremia following vaccination
Measured: Measured through Day 360
Number of flavivirus-experienced vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4
Infection is defined as recovery of vaccine virus from the blood or serum of a participant and/or by developing seropositivity to DEN virus (plaque reduction neutralization titer [PRNT]50 greater than or equal to 1:10).
Measured: Measured through Day 360
Duration of the neutralizing antibody response
Measured: Measured 26 weeks after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 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
- NCT01506570
- Sponsor's protocol ID
- CIR 280
- Status last verified
- Aug 2015
- First submitted
- 5 Jan 2012
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhamarapravati N, Sutee Y. Live attenuated tetravalent dengue vaccine. Vaccine. 2000 May 26;18 Suppl 2:44-7. doi: 10.1016/s0264-410x(00)00040-2.
PubMed 10821973Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
PubMed 16553547Durbin AP, Kirkpatrick BD, Pierce KK, Schmidt AC, Whitehead SS. Development and clinical evaluation of multiple investigational monovalent DENV vaccines to identify components for inclusion in a live attenuated tetravalent DENV vaccine. Vaccine. 2011 Sep 23;29(42):7242-50. doi: 10.1016/j.vaccine.2011.07.023. Epub 2011 Jul 21.
PubMed 21781997Whitehead SS, Durbin AP, Pierce KK, Elwood D, McElvany BD, Fraser EA, Carmolli MP, Tibery CM, Hynes NA, Jo M, Lovchik JM, Larsson CJ, Doty EA, Dickson DM, Luke CJ, Subbarao K, Diehl SA, Kirkpatrick BD. In a randomized trial, the live attenuated tetravalent dengue vaccine TV003 is well-tolerated and highly immunogenic in subjects with flavivirus exposure prior to vaccination. PLoS Negl Trop Dis. 2017 May 8;11(5):e0005584. doi: 10.1371/journal.pntd.0005584. eCollection 2017 May.
PubMed 28481883
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 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 the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixtures TV003 and TV005 in Healthy Flavivirus-experienced Adult Subjects
- ClinicalTrials.gov ID
- NCT01506570
- Acronym / sponsor ID
- CIR 280
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Jan 2012 (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 serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy adults who have previously been infected with a dengue virus or other flavivirus or have previously received a flavivirus vaccine.
Detailed description
Dengue viruses cause dengue fever and the more severe condition, dengue hemorrhagic fever/shock syndrome. Dengue viruses are common in most tropical and subtropical regions of the world and infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries. For these reasons, the World Health Organization (WHO) has made the development of a dengue virus vaccine a top priority. This study will evaluate the safety and immunogenicity of two doses of a live attenuated, tetravalent dengue virus vaccine called TetraVax-DV in healthy adults (18-50 years old) who have previously been infected with a dengue virus or other flavivirus or have previously received a flavivirus vaccine. Two different formulations of the TetraVax-DV vaccine will be evaluated.
Participants will be randomly assigned to receive one of two admixtures of the TetraVax-DV vaccine or a placebo. At a baseline study visit (Day 0), participants will undergo a medical history review, physical examination, blood collection, vital sign measurements, and a pregnancy test for females. Participants will then receive one subcutaneous (SC) injection of their assigned vaccine or placebo in the upper arm. After receiving the vaccine, participants will remain in the clinic for 30 minutes for observation and monitoring. At home, participants will monitor and record their temperature three times a day for 16 days after the first vaccination (from Day 0 through Day 16) and for 16 days after the second vaccination (from Day 180 through Day 196). Additional study visits will occur at Days 3, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 150 and will include a physical examination, vital sign measurements, and blood collection. On Day 180, participants will receive a second SC injection of their assigned vaccine or placebo. Additional study visits will then occur at Days 183, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360, and will include the same study procedures and monitoring that occurred after the first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TetraVax-DV Vaccine - Admixture TV003 | Experimental | Biological: TetraVax-DV Vaccine - Admixture TV003Participants will receive one SC injection of the TetraVax-DV Vaccine - Admixture TV003 in their upper arm at Day 0 and Day 180. |
| TetraVax-DV Vaccine - Admixture TV005 | Experimental | Biological: TetraVax-DV Vaccine - Admixture TV005Participants will receive one SC injection of the TetraVax-DV Vaccine - Admixture TV005 in their upper arm at Day 0 and Day 180. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive one SC injection of placebo in their upper arm at Day 0 and Day 180. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In good general health, as determined by physical examination, laboratory screening, and review of medical history
- Documented history or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus [YFV], St. Louis encephalitis virus [SLE], West Nile virus [WNV], Japanese encephalitis virus [JEV], or tick-borne encephalitis virus [TBEV]) or documented previous receipt of a flavivirus vaccine (licensed or experimental)
- Available for the duration of the study, approximately 26 weeks post-second vaccination
- Willing to participate in the study as evidenced by signing the informed consent document
- Female participants of childbearing potential must be 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 (52 listed)
- Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test, or breastfeeding
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, 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
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in the 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
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 Vaccine - Admixture TV003One SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV003 (10^3 plaque-forming unit [PFU] of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30) | Biological | TetraVax-DV Vaccine - Admixture TV003 |
| TetraVax-DV Vaccine - Admixture TV005One SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV005 (10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30) | Biological | TetraVax-DV Vaccine - Admixture TV005 |
| PlaceboOne SC injection at Day 0 and Day 180 of placebo | Biological | Placebo |
Primary outcome
Safety of TetraVax-DV TV003 and TV005, as assessed by the frequency of vaccine-related adverse events
Time frame: Measured through Day 360
Immunogenicity of TV003 and TV005, as assessed by neutralizing antibody titers to DENV-1, DENV-2, DENV-3, and DENV-4
Time frame: Measured 28, 56, 90, and 180 days after each vaccination
Monovalent, bivalent, trivalent, and tetravalent seropositivity rates will be determined at 28, 56, and 90 days after each vaccination.
Whether a second dose of the vaccine given at Day 180 will induce seropositivity in those participants that remained seronegative to one or more DENV serotypes following the first vaccination
Time frame: Measured through Day 360
3 secondary outcomes
Frequency, quantity, and duration of viremia following vaccination
Time frame: Measured through Day 360
Number of flavivirus-experienced vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4
Time frame: Measured through Day 360
Duration of the neutralizing antibody response
Time frame: Measured 26 weeks after each vaccination
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 20 Aug 2015.
- Background: PubMed 10821973Bhamarapravati N, Sutee Y. Live attenuated tetravalent dengue vaccine. Vaccine. 2000 May 26;18 Suppl 2:44-7. doi: 10.1016/s0264-410x(00)00040-2.
- Background: PubMed 16553547Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
- Background: PubMed 21781997Durbin AP, Kirkpatrick BD, Pierce KK, Schmidt AC, Whitehead SS. Development and clinical evaluation of multiple investigational monovalent DENV vaccines to identify components for inclusion in a live attenuated tetravalent DENV vaccine. Vaccine. 2011 Sep 23;29(42):7242-50. doi: 10.1016/j.vaccine.2011.07.023. Epub 2011 Jul 21.
- Derived from this study: PubMed 28481883Whitehead SS, Durbin AP, Pierce KK, Elwood D, McElvany BD, Fraser EA, Carmolli MP, Tibery CM, Hynes NA, Jo M, Lovchik JM, Larsson CJ, Doty EA, Dickson DM, Luke CJ, Subbarao K, Diehl SA, Kirkpatrick BD. In a randomized trial, the live attenuated tetravalent dengue vaccine TV003 is well-tolerated and highly immunogenic in subjects with flavivirus exposure prior to vaccination. PLoS Negl Trop Dis. 2017 May 8;11(5):e0005584. doi: 10.1371/journal.pntd.0005584. eCollection 2017 May.
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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
3 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 Vaccine - Admixture TV003 and TetraVax-DV Vaccine - Admixture TV005 in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Safety of TetraVax-DV TV003 and TV005, as assessed by the frequency of vaccine-related adverse events (time frame: Measured through Day 360). 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?
On the ClinicalTrials.gov record for NCT01506570, which also lists 4 linked publications.
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 20 Aug 2015.