Dengue FeverPhase 1NCT01728792
Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity
A Phase 1 study testing TDV in people with Dengue Fever, run by Takeda at 1 site in United States.
Trial summary
This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- What is being tested?
- TDV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2013to 21 Nov 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women at least 18 years and ≤ 45 years of age at time of screening.
- In good health as determined by medical history and physical examination (including blood pressure and heart rate).
- Weight: Body Mass Index (BMI) ≤ 35.
- Blood tests negative for antibodies to human immunodeficiency virus-1 (HIV-1), Hepatitis C, and Hepatitis B surface antigen.
- Females who are not surgically sterile or post-menopausal must have a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal foam, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until the blood sample on Day 120.
- Willing and able to give written informed consent to participate.
- Willing and able to communicate with the Investigator and understand the requirements of the study.
- Access to a fixed or mobile telephone.
Who cannot join
- Any condition which would limit the participant's ability to complete the study in the opinion of the Investigator.
- Any Grade 2 or above abnormality in the screening laboratory tests.
- Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or infection within three days before vaccination.
- History of any significant dermatologic disease in the last 6 months, particularly with a maculopapular or petechial rash. However, if a participant had a self-limited Candida infection that was cured, then the participant can be enrolled if there is no evidence of an infection for at least 3 weeks prior to the date of dosing. If the participant has acne limited to the face, topical medications are allowed except for 2 weeks prior and 4 weeks after each dose. Oral medications for acne are excluded for 1 month prior to the start of dosing.
- History of dengue fever, Japanese encephalitis, West Nile, or Yellow Fever disease.
- Seropositivity to dengue or West Nile (WN) virus.
Show all 23Show fewer
- History of travel to dengue endemic areas including the Caribbean, Mexico, Central America, South America or Southeast Asia during the month prior to screening, or planned travel to a dengue endemic area during the study period.
- Extensive scarring or tattoo (> 50%) on arms, shoulders, neck, face and head that could identify a participant in photos or hinder the evaluation of injection site reactions. In addition, no tattoo on the arms is permitted during the study and for one month after the final injection.
- History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines.
- Hypersensitivity to any vaccine.
- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the Day 0 or 90 injections.
- Previous vaccination (in a clinical trial or with an approved product) against yellow fever (YF) or Japanese Encephalitis (JE).
- Known or suspected congenital or acquired immunodeficiency or immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months.
- Use of systemic corticosteroids therapy within the previous 6 months (at a dose of at least 0.5 mg/kg/day prednisone equivalent). Topical prednisone is not permitted if currently in use or used within the last month. Inhaled prednisone is permitted.
- Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination.
- History of diabetes mellitus.
- History of thymic pathology, thymectomy, myasthenia or any immunodeficiency.
- Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
- Known history of alcohol abuse.
- Receipt of any other investigational product or participation in any other clinical trial of a product or device within 30 days before the first vaccination (Day 0) or planned participation in any other clinical trial while enrolled in this trial (though Day 120).
- Receipt of blood products or immunoglobulins 8 weeks before the first vaccination (Day 0) or planned use during the period of this study (through Day 120).
- Planned donation of blood during the period of this study (through Day 120).
- Females who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Impact of Subcutaneous Versus Intramuscular Administration of Inviragen's Live Attenuated Dengue Vaccine on Safety and Immunogenicity
This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™).
Read the detailed description
The vaccine tested in this study was TDV. TDV was tested to assess safety and immunogenicity of various dosing schedules, routes of administration, and delivery methods in healthy flavivirus-seronegative adults living in a dengue non-endemic country.
The study enrolled 80 participants. Participants were randomly assigned to one of the five treatment groups:
- Group 1: TDV SC injection on Day 0 in each arm using needle/syringe
- Group 2: TDV IM injection on Day 0 in each arm using needle/syringe
- Group3: TDV IM injection on Days 0 and 90 using needle/syringe
- Group 4: TDV SC on Day 0 in each arm using the PharmaJet Stratis™ device
- Group 5: TDV IM on Day 0 in each arm using the PharmaJet Stratis™ device
This single-center trial was conducted in the United States. The overall time to participate in this study was up to 5 months. Participants made multiple visits to the clinic including a final visit at Day 120 for a safety follow-up assessment.
This work was supported by the US Army Medical Research and Materiel Command under Contract No. W81XWH-12-C-0278.
The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.
- Conditions
- Dengue Fever
- Being tested
- TDV
- Keywords
- Prophylactic vaccination
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDVBiological
Also called DENVax
TDV IM or SC injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1: TDV SC_2 Doses Day 0 | Experimental | Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using a needle/syringe. Receives: Biological: TDV |
| Group 2: TDV IM_2 Doses Day 0 | Experimental | TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using a needle/syringe. Receives: Biological: TDV |
| Group 3: TDV IM_2 Doses Days 0 and 90 | Experimental | TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using a needle/syringe. Receives: Biological: TDV |
| Group 4: TDV SC_2 Doses Day 0 | Experimental | TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device. Receives: Biological: TDV |
| Group 5: TDV IM_2 Doses Day 0 | Experimental | TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device. Receives: Biological: TDV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=<2.5 centimeters (cm) to 3=Severe: >10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Measured: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=< 2.5 cm to 3= Severe: > 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Measured: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.
Measured: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.
Measured: For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)
Number of Participants With at Least 1 Serious Adverse Event During the Study
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Measured: First Vaccination to End of Study (Up to Day 120)
Seroconversion Rate to Each of Four Dengue Serotypes
Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.
Measured: Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)
Secondary outcomes (2)
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. "n" in each of the categories is the number of participants with data available.
Measured: Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
Measured: Days 28, 90 and 120 after 1st vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study start22 Jan 2013
- Primary completion1 Nov 2013
- Study completion21 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728792
- Sponsor's protocol ID
- INV-DEN-105
- Other IDs
- U1111-1181-0251
- Status last verified
- Jul 2019
- First submitted
- 16 Oct 2012
- Last updated
- 18 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Subcutaneous Versus Intramuscular Administration of Inviragen's Live Attenuated Dengue Vaccine on Safety and Immunogenicity
- ClinicalTrials.gov ID
- NCT01728792
- Acronym / sponsor ID
- INV-DEN-105
- Conditions
- Dengue Fever
- Keywords
- Prophylactic vaccination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 22 Jan 2013 (actual)
- Primary completion
- 1 Nov 2013 (actual)
- Study completion
- 21 Nov 2013 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™).
Detailed description
The vaccine tested in this study was TDV. TDV was tested to assess safety and immunogenicity of various dosing schedules, routes of administration, and delivery methods in healthy flavivirus-seronegative adults living in a dengue non-endemic country.
The study enrolled 80 participants. Participants were randomly assigned to one of the five treatment groups:
- Group 1: TDV SC injection on Day 0 in each arm using needle/syringe
- Group 2: TDV IM injection on Day 0 in each arm using needle/syringe
- Group3: TDV IM injection on Days 0 and 90 using needle/syringe
- Group 4: TDV SC on Day 0 in each arm using the PharmaJet Stratis™ device
- Group 5: TDV IM on Day 0 in each arm using the PharmaJet Stratis™ device
This single-center trial was conducted in the United States. The overall time to participate in this study was up to 5 months. Participants made multiple visits to the clinic including a final visit at Day 120 for a safety follow-up assessment.
This work was supported by the US Army Medical Research and Materiel Command under Contract No. W81XWH-12-C-0278.
The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: TDV SC_2 Doses Day 0 | Experimental | Biological: TDVTakeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using a needle/syringe. |
| Group 2: TDV IM_2 Doses Day 0 | Experimental | Biological: TDVTDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using a needle/syringe. |
| Group 3: TDV IM_2 Doses Days 0 and 90 | Experimental | Biological: TDVTDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using a needle/syringe. |
| Group 4: TDV SC_2 Doses Day 0 | Experimental | Biological: TDVTDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device. |
| Group 5: TDV IM_2 Doses Day 0 | Experimental | Biological: TDVTDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women at least 18 years and ≤ 45 years of age at time of screening.
- In good health as determined by medical history and physical examination (including blood pressure and heart rate).
- Weight: Body Mass Index (BMI) ≤ 35.
- Blood tests negative for antibodies to human immunodeficiency virus-1 (HIV-1), Hepatitis C, and Hepatitis B surface antigen.
- Females who are not surgically sterile or post-menopausal must have a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal foam, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until the blood sample on Day 120.
Key exclusion criteria (23 listed)
- Any condition which would limit the participant's ability to complete the study in the opinion of the Investigator.
- Any Grade 2 or above abnormality in the screening laboratory tests.
- Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or infection within three days before vaccination.
- History of any significant dermatologic disease in the last 6 months, particularly with a maculopapular or petechial rash. However, if a participant had a self-limited Candida infection that was cured, then the participant can be enrolled if there is no evidence of an infection for at least 3 weeks prior to the date of dosing. If the participant has acne limited to the face, topical medications are allowed except for 2 weeks prior and 4 weeks after each dose. Oral medications for acne are excluded for 1 month prior to the start of dosing.
- History of dengue fever, Japanese encephalitis, West Nile, or Yellow Fever disease.
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 |
|---|---|---|
| TDVAlso: DENVaxTDV IM or SC injection | Biological | Group 1: TDV SC_2 Doses Day 0, Group 2: TDV IM_2 Doses Day 0, Group 3: TDV IM_2 Doses Days 0 and 90, Group 4: TDV SC_2 Doses Day 0, Group 5: TDV IM_2 Doses Day 0 |
Primary outcome
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Time frame: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=<2.5 centimeters (cm) to 3=Severe: >10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Time frame: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=< 2.5 cm to 3= Severe: > 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Time frame: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.
Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose
Time frame: For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.
Number of Participants With at Least 1 Serious Adverse Event During the Study
Time frame: First Vaccination to End of Study (Up to Day 120)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Seroconversion Rate to Each of Four Dengue Serotypes
Time frame: Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)
Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.
2 secondary outcomes
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Time frame: Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
Time frame: Days 28, 90 and 120 after 1st vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TDV in people with Dengue Fever, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator (time frame: For 14 days after each vaccination (Up to Day 14 and/or Day 104)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.