Healthy VolunteersPhase 1NCT01765426

Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector

A Phase 1 study testing TDV in people with Healthy Volunteers, run by Takeda at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: TDV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 2 sitesUnited States
Study dates: 15 Feb 2013to 26 Jun 2014
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

In good health as determined by medical history and physical examination (including blood pressure and heart rate).
Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies \& Hepatitis B surface antigen.
Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception.
Body Mass Index (BMI) ≤ 35 kg/m^2.

Who cannot join

Any Grade 2 or above abnormality in the screening laboratory tests.
History of Dengue Fever, Japanese Encephalitis, West Nile or Yellow Fever disease.
Seropositivity to dengue or West Nile virus.
Extensive scarring or tattoo (> 50%) on arms, shoulders, neck face and head.
History of significant dermatologic disease in the last 6 months.
Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the Day 0 or 90 vaccinations.

Show all 12Show fewer

Any planned travel to dengue endemic areas including the Caribbean, Mexico, Central America, South America or Southeast Asia, during the study period and during the month prior to screening.
Use of systemic corticosteroids therapy within the previous 6 months (at a dose of 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or used within the last month prior to the first vaccination.
Use of any prescribed medication 7 days before the first injection.
Previous vaccination in a clinical study or with an approved product against Dengue Fever, Yellow Fever and or Japanese Encephalitis.
Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy in the last 6 months.
Planned donation of blood during the period of the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Texas Medical Branch
Galveston, Texas, 77555
Group Health Research Institute
Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Phase 1b, Partial-Blind, Parallel Group, Randomized Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine (DENVax) Administered Intradermally Using Needle or a Needle-Free PharmaJet® Injector in Healthy Adults

Read the detailed description

This is an exploratory trial to assess the safety, tolerability and immunogenicity of vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector.

Two (2) intradermal injections of either vaccine or placebo will be administered to qualified participants (one in each arm) on Day 0 of the study. A subsequent injection will also be given on Day 90 with either vaccine or placebo (in one arm only).

Participants will be evaluated for safety and dengue neutralizing antibody to all four serotypes. All participants will also be evaluated for injection site reactions and have blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.

Participants will be required to participate for approximately 10 months from recruitment and collection of data for primary outcomes (through Day 120) including collection of additional samples for measurement of longer term antibody titers (through Day 270).

This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201000034C.

Conditions: Healthy Volunteers
Being tested: TDV, Placebo
Keywords: Prophylactic vaccination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TDVBiological
TDV suspension for intradermal administration
PlaceboDrug
Phosphate buffered saline (PBS)

Study groups in NCT01765426
Study group	Role	What they receive
Group 1: TDV using PharmaJet® Injector	Experimental	Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. Receives: Biological: TDV; Drug: Placebo
Group 2: TDV using PharmaJet® Injector	Experimental	TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. Receives: Biological: TDV; Drug: Placebo
Group 3: TDV using Needle and Syringe	Experimental	TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. Receives: Biological: TDV; Drug: Placebo
Group 4: TDV using PharmaJet® Injector	Experimental	TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. Receives: Biological: TDV

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage 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.
Measured: 28 Days after each dose
Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade.
Measured: 28 Days after each dose
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage 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.
Measured: 14 days after each dose
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
Measured: 14 days after each dose
Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Measured: 28 Days after each dose
Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs.
Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention.
Measured: 118 Days
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Measured: Day 28
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Measured: Day 118
Percentage of Participants With Unsolicited Vaccine-Related SAEs
A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.
Measured: Dose 1 until 28 days after Dose 2 (Up to Day 118)

Secondary outcomes (3)

Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Measured: Days 0, 28, 90, 118 and 270
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Measured: Days 90 and 270
Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination
A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6. The percentage of participants with positive results is reported.
Measured: Day 0 to Day 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201326 Jun 2014

First posted10 Jan 2013 (estimated)
Study start15 Feb 2013
Primary completion26 Jun 2014
Study completion26 Jun 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01765426
Sponsor's protocol ID: 11-0049
Other IDs: U1111-1178-6503
Status last verified: Jul 2019
First submitted: 17 Dec 2012
Last updated: 18 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Jackson LA, Rupp R, Papadimitriou A, Wallace D, Raanan M, Moss KJ. A phase 1 study of safety and immunogenicity following intradermal administration of a tetravalent dengue vaccine candidate. Vaccine. 2018 Jun 22;36(27):3976-3983. doi: 10.1016/j.vaccine.2018.05.028. Epub 2018 May 19.
PubMed 29789238

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteers trials

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: Phase 1b, Partial-Blind, Parallel Group, Randomized Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine (DENVax) Administered Intradermally Using Needle or a Needle-Free PharmaJet® Injector in Healthy Adults
ClinicalTrials.gov ID: NCT01765426
Acronym / sponsor ID: 11-0049
Conditions: Healthy Volunteers
Keywords: Prophylactic vaccination
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Collaborators: National Institutes of Health (NIH)
Study start: 15 Feb 2013 (actual)
Primary completion: 26 Jun 2014 (actual)
Study completion: 26 Jun 2014 (actual)
First posted: 10 Jan 2013 (estimated)
Results: Posted 5 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1: TDV using PharmaJet® Injector	Experimental	Biological: TDV, Drug: PlaceboTakeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
Group 2: TDV using PharmaJet® Injector	Experimental	Biological: TDV, Drug: PlaceboTDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
Group 3: TDV using Needle and Syringe	Experimental	Biological: TDV, Drug: PlaceboTDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
Group 4: TDV using PharmaJet® Injector	Experimental	Biological: TDVTDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

In good health as determined by medical history and physical examination (including blood pressure and heart rate).
Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies \& Hepatitis B surface antigen.
Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception.
Body Mass Index (BMI) ≤ 35 kg/m^2.

Key exclusion criteria (12 listed)

Any Grade 2 or above abnormality in the screening laboratory tests.
History of Dengue Fever, Japanese Encephalitis, West Nile or Yellow Fever disease.
Seropositivity to dengue or West Nile virus.
Extensive scarring or tattoo (> 50%) on arms, shoulders, neck face and head.
History of significant dermatologic disease in the last 6 months.

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
TDVTDV suspension for intradermal administration	Biological	Group 1: TDV using PharmaJet® Injector, Group 2: TDV using PharmaJet® Injector, Group 3: TDV using Needle and Syringe, Group 4: TDV using PharmaJet® Injector
PlaceboPhosphate buffered saline (PBS)	Drug	Group 1: TDV using PharmaJet® Injector, Group 2: TDV using PharmaJet® Injector, Group 3: TDV using Needle and Syringe

Primary outcome

Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Time frame: 28 Days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage 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.
Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
Time frame: 28 Days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade.
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Time frame: 14 days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage 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.
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Time frame: 14 days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity
Time frame: 28 Days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
Time frame: 118 Days
The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs. Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention.
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection
Time frame: Day 28
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection
Time frame: Day 118
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Percentage of Participants With Unsolicited Vaccine-Related SAEs
Time frame: Dose 1 until 28 days after Dose 2 (Up to Day 118)
A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.

3 secondary outcomes

Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Time frame: Days 0, 28, 90, 118 and 270
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Time frame: Days 90 and 270
Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination
Time frame: Day 0 to Day 104

Results and safety

Results posted to the registry on 5 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: TDV Using PharmaJet® Injector	18	18
Group 2: TDV Using PharmaJet® Injector	17	16
Group 3: TDV Using Needle and Syringe	17	17
Group 4: TDV Using PharmaJet® Injector	15	15

Primary outcome: Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff

Time frame: 28 Days after each dose. Number. Unit: percentage of participants

Measure	Group 1: TDV Using PharmaJet® Injector n = 18	Group 2: TDV Using PharmaJet® Injector n = 17	Group 3: TDV Using Needle and Syringe n = 17	Group 4: TDV Using PharmaJet® Injector n = 15
Edema, Grade 0 (None)	16.7	11.8	11.8	13.3
Edema, Any Severity >Grade 0	83.3	88.2	88.2	86.7
Edema, Grade 1 (Mild)	77.8	82.4	76.5	66.7
Edema, Grade 2 (Moderate)	5.6	5.9	11.8	20.0
Erythema, Grade 0 (None)	11.1	0	0	6.7
Erythema, Any Severity >Grade 0	88.9	100.0	100.0	93.3
Erythema, Grade 1 (Mild)	55.6	23.5	29.4	20.0
Erythema, Grade 2 (Moderate)	33.3	70.6	64.7	60.0

Population analysed: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.

Primary outcome: Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity

Time frame: 28 Days after each dose. Number. Unit: percentage of participants

Measure	Group 1: TDV Using PharmaJet® Injector n = 18	Group 2: TDV Using PharmaJet® Injector n = 17	Group 3: TDV Using Needle and Syringe n = 17	Group 4: TDV Using PharmaJet® Injector n = 15
Any Severity	83.3	76.5	88.2	80.0
Grade 1 (Mild)	22.2	35.3	52.9	53.3
Grade 2 (Moderate)	44.4	23.5	17.6	20.0
Grade 3 (Severe)	11.1	17.6	5.9	6.7
Grade 4 (Life Threatening)	5.6	0	11.8	0

Population analysed: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.

Primary outcome: Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity

Time frame: 14 days after each dose. Number. Unit: percentage of participants

Measure	Group 1: TDV Using PharmaJet® Injector n = 18	Group 2: TDV Using PharmaJet® Injector n = 17	Group 3: TDV Using Needle and Syringe n = 17	Group 4: TDV Using PharmaJet® Injector n = 15
Temperature, Grade 0 (None)	94.4	100.0	88.2	100.0
Temperature, Any Severity >Grade 0	5.6	0	11.8	0
Temperature, Grade 1 (Mild)	5.6	0	5.9	0
Temperature, Grade 2 (Moderate)	0	0	5.9	0
Headache, Grade 0 (None)	61.1	29.4	41.2	46.7
Headache, Any Severity >Grade 0	38.9	70.6	58.8	53.3
Headache, Grade 1 (Mild)	22.2	58.8	58.8	46.7
Headache, Grade 2 (Moderate)	16.7	11.8	0	6.7

Population analysed: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.

Primary outcome: Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity

Time frame: 14 days after each dose. Number. Unit: percentage of participants

Measure	Group 1: TDV Using PharmaJet® Injector n = 18	Group 2: TDV Using PharmaJet® Injector n = 17	Group 3: TDV Using Needle and Syringe n = 17	Group 4: TDV Using PharmaJet® Injector n = 15
Swelling, Grade 0 (None)	50.0	41.2	35.3	40.0
Swelling, Any Severity >Grade 0	50.0	58.8	64.7	60.0
Swelling, Grade 1 (Mild)	44.4	47.1	47.1	40.0
Swelling, Grade 2 (Moderate)	5.6	11.8	17.6	20.0
Redness, Grade 0	22.2	0	0	20.0
Redness, Any Severity >Grade 0	77.8	100	100.0	80.0
Redness, Grade 1 (Mild)	44.4	29.4	23.5	13.3
Redness, Grade 2 (Moderate)	33.3	64.7	64.7	46.7

Population analysed: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: TDV Using PharmaJet® Injector	0 of 18 (0%)	15 of 18 (83.3%)	Not reported
Group 2: TDV Using PharmaJet® Injector	0 of 17 (0%)	13 of 17 (76.5%)	Not reported
Group 3: TDV Using Needle and Syringe	0 of 17 (0%)	15 of 17 (88.2%)	Not reported
Group 4: TDV Using PharmaJet® Injector	0 of 15 (0%)	12 of 15 (80%)	Not reported

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.
Derived from this study: PubMed 29789238Jackson LA, Rupp R, Papadimitriou A, Wallace D, Raanan M, Moss KJ. A phase 1 study of safety and immunogenicity following intradermal administration of a tetravalent dengue vaccine candidate. Vaccine. 2018 Jun 22;36(27):3976-3983. doi: 10.1016/j.vaccine.2018.05.028. Epub 2018 May 19.

Related trials for Healthy Volunteers

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

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

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 TDV in people with Healthy Volunteers, run by Takeda 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 4 inclusion and 12 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 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. 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 5 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?

Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff (time frame: 28 Days after each dose). The study lists 9 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 NCT01765426, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.