DenguePhase 1NCT01436422
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. 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
- 112 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2011to Mar 2014
- 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
- Available for the duration of the study, approximately 26 weeks post-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.
- 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
- 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 50Show 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
- History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis virus, West Nile virus)
- Previous receipt of a flavivirus vaccine (licensed or experimental)
- Anticipated receipt of any investigational agent in the 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
- 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 which 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
- 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 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, 21205
Fletcher Allen Health Care (FAHC), General Clinical Research Center (GCRC)
Burlington, Vermont, 05401
University of Vermont Vaccine Testing Center
Burlington, Vermont, 05405
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-Naïve 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.
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. Two different versions of the TetraVax-DV vaccine will be evaluated.
This study will enroll healthy adults 18-50 years old. Participants will be randomly assigned to receive one of two admixtures of the TetraVax-DV vaccine or a placebo. At a baseline study visit, 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 injection of their assigned vaccine 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. 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, assessment of symptoms, and blood collection. On Day 180, participants will receive a second injection of the same vaccine they received at the baseline study visit. Follow-up study visits will 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
- Keywords
- Dengue Virus, Dengue Fever, Dengue Vaccine, Dengue Hemorrhagic Fever, Dengue Shock Syndrome
- Medical subject headings
- Dengue, Severe 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 subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV003 (10^3 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 subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant 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 subcutaneous injection at Day 0 and Day 180 of placebo
| Study group | Role | What they receive |
|---|---|---|
| TetraVax-DV Vaccine - Admixture TV003 | Experimental | Participants will receive the TetraVax-DV Vaccine - Admixture TV003 at Day 0 and Day 180. Receives: Biological: TetraVax-DV Vaccine - Admixture TV003 |
| TetraVax-DV Vaccine - Admixture TV005 | Experimental | Participants will receive the TetraVax-DV Vaccine - Admixture TV005 at Day 0 and Day 180. Receives: Biological: TetraVax-DV Vaccine - Admixture TV005 |
| Placebo | Placebo comparator | Participants will receive the placebo 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 two TetraVax-DV admixtures, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity
Measured: Measured through Day 360
Immunogenicity of two TetraVax-DV admixtures, as assessed by neutralizing antibody titers to DEN1, DEN2, DEN3, and DEN4
Monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates will be determined at 28, 56, and 90 days after each vaccination.
Measured: Measured through Day 180 after each vaccination
Seropositivity in those vaccinees who remained seronegative to one or more DENV serotypes following the first vaccination and who recieved a second dose of vaccine given at Day 180
Measured: Measured through Day 360
Secondary outcomes (10)
Frequency of viremia following vaccination
Measured: Measured through Day 360
Number of vaccinees infected with DEN1, DEN2, DEN3, and DEN4
Infection is defined as recovery of vaccine virus from the blood or serum of a participant and/or by seropositivity to DEN virus (PRNT50 greater than or equal to 1:10).
Measured: Measured through Day 360
Duration of the neutralizing antibody response 26 weeks after each vaccination
Measured: Measured 26 weeks after each vaccination
Ability of a second dose of vaccine to boost serum neutralizing antibody titers by Day 270
Boost will be defined as a greater than or equal to 4-fold rise in serum neutralizing antibody titer by Day 270 compared with Day 180.
Measured: Measured at Day 270
Evaluate the phenotype of peripheral blood mononuclear cells at primary infection with the TetraVax-DV vaccine
Measured: Measured through Day 360
Evaluate the cellular immune response to primary infection with the TetraVax-DV vaccine
Measured: Measured through Day 360
Evaluate the innate immune response to primary infection with the TetraVax-DV vaccine
Measured: Measured through Day 360
Evaluate B and T cell memory responses following primary and secondary infections with TetraVax-DV vaccine
Measured: Measured through Day 360
Quantity of viremia following vaccination
Measured: Measured through Day 360
Duration of viremia following vaccination
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 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionMar 2014
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
- 112 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
- NCT01436422
- Sponsor's protocol ID
- CIR 279
- Status last verified
- Aug 2015
- First submitted
- 16 Sep 2011
- 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 21781997Kirkpatrick BD, Durbin AP, Pierce KK, Carmolli MP, Tibery CM, Grier PL, Hynes N, Diehl SA, Elwood D, Jarvis AP, Sabundayo BP, Lyon CE, Larsson CJ, Jo M, Lovchik JM, Luke CJ, Walsh MC, Fraser EA, Subbarao K, Whitehead SS. Robust and Balanced Immune Responses to All 4 Dengue Virus Serotypes Following Administration of a Single Dose of a Live Attenuated Tetravalent Dengue Vaccine to Healthy, Flavivirus-Naive Adults. J Infect Dis. 2015 Sep 1;212(5):702-10. doi: 10.1093/infdis/jiv082. Epub 2015 Mar 22.
PubMed 25801652
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-Naïve Adult Subjects
- ClinicalTrials.gov ID
- NCT01436422
- Acronym / sponsor ID
- CIR 279
- Conditions
- Dengue
- Keywords
- Dengue Virus, Dengue Fever, Dengue Vaccine, Dengue Hemorrhagic Fever, Dengue Shock Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Sep 2011 (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.
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. Two different versions of the TetraVax-DV vaccine will be evaluated.
This study will enroll healthy adults 18-50 years old. Participants will be randomly assigned to receive one of two admixtures of the TetraVax-DV vaccine or a placebo. At a baseline study visit, 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 injection of their assigned vaccine 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. 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, assessment of symptoms, and blood collection. On Day 180, participants will receive a second injection of the same vaccine they received at the baseline study visit. Follow-up study visits will 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 the TetraVax-DV Vaccine - Admixture TV003 at Day 0 and Day 180. |
| TetraVax-DV Vaccine - Admixture TV005 | Experimental | Biological: TetraVax-DV Vaccine - Admixture TV005Participants will receive the TetraVax-DV Vaccine - Admixture TV005 at Day 0 and Day 180. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive the placebo 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 (8 listed)
- In good general health, as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study, approximately 26 weeks post-vaccination
- 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.
- In good general health, as determined by physical examination and review of medical history
Key exclusion criteria (50 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 subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV003 (10^3 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 subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant 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 subcutaneous injection at Day 0 and Day 180 of placebo | Biological | Placebo |
Primary outcome
Safety of two TetraVax-DV admixtures, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity
Time frame: Measured through Day 360
Immunogenicity of two TetraVax-DV admixtures, as assessed by neutralizing antibody titers to DEN1, DEN2, DEN3, and DEN4
Time frame: Measured through Day 180 after each vaccination
Monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates will be determined at 28, 56, and 90 days after each vaccination.
Seropositivity in those vaccinees who remained seronegative to one or more DENV serotypes following the first vaccination and who recieved a second dose of vaccine given at Day 180
Time frame: Measured through Day 360
10 secondary outcomes
Frequency of viremia following vaccination
Time frame: Measured through Day 360
Number of vaccinees infected with DEN1, DEN2, DEN3, and DEN4
Time frame: Measured through Day 360
Duration of the neutralizing antibody response 26 weeks after each vaccination
Time frame: Measured 26 weeks after each vaccination
Ability of a second dose of vaccine to boost serum neutralizing antibody titers by Day 270
Time frame: Measured at Day 270
Evaluate the phenotype of peripheral blood mononuclear cells at primary infection with the TetraVax-DV vaccine
Time frame: Measured through Day 360
Evaluate the cellular immune response to primary infection with the TetraVax-DV vaccine
Time frame: Measured through Day 360
Evaluate the innate immune response to primary infection with the TetraVax-DV vaccine
Time frame: Measured through Day 360
Evaluate B and T cell memory responses following primary and secondary infections with TetraVax-DV vaccine
Time frame: Measured through Day 360
Quantity of viremia following vaccination
Time frame: Measured through Day 360
Duration of viremia following vaccination
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 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 25801652Kirkpatrick BD, Durbin AP, Pierce KK, Carmolli MP, Tibery CM, Grier PL, Hynes N, Diehl SA, Elwood D, Jarvis AP, Sabundayo BP, Lyon CE, Larsson CJ, Jo M, Lovchik JM, Luke CJ, Walsh MC, Fraser EA, Subbarao K, Whitehead SS. Robust and Balanced Immune Responses to All 4 Dengue Virus Serotypes Following Administration of a Single Dose of a Live Attenuated Tetravalent Dengue Vaccine to Healthy, Flavivirus-Naive Adults. J Infect Dis. 2015 Sep 1;212(5):702-10. doi: 10.1093/infdis/jiv082. Epub 2015 Mar 22.
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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 8 inclusion and 50 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 two TetraVax-DV admixtures, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity (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 NCT01436422, 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.