DenguePhase 2NCT03485144
A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan
A Phase 2 study testing TV003 in people with Dengue, run by Medigen Vaccine Biologics Corp. at 1 site in Taiwan.
Trial summary
The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- TV003
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Dec 2017to 10 May 2019
- Phase
- Phase 2
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female between 20 and 70 years of age
- Good general health as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study
- Willingness to sign the informed consent document
- Female of childbearing potential willing to use effective contraception for the duration of the trial
Who cannot join
- Females currently pregnant, as determined by positive β- human choriogonadotropin (HCG) test, and/or breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, or psychiatric disease
- Below lower limit of normal for absolute neutrophil count
- Any significant alcohol or drug abuse in the past 12 months
- History of a severe allergic reaction or anaphylaxis
Show all 19Show fewer
- Self-reported systemic hypersensitivity to any of the vaccine components
- Severe asthma
- Known HIV, Hepatitis B or hepatitis C
- Any known immunodeficiency syndrome
- Use of anticoagulant medications
- Receive chronic administration of immunosuppressant drugs within 6 months prior to the administration of the study vaccine
- Use of any investigational product within 30 days before study vaccination or at any time during the study
- Asplenia
- Receive administration of immunoglobulins and/or any blood products within 12 months preceding the administration of the study vaccine or at any time during the study
- Fever or suspected fever within 72 hours prior to vaccination or tympanic temperature greater than 38°C on the day of vaccination
- Receive administration of any licensed live attenuated vaccines within 30 days preceding the administration of the study vaccine and ending 30 days after
- Receive administration of any licensed inactivated vaccines within 14 days preceding the administration of the study vaccine and ending 14 days after
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Immunogenicity and Safety of TetraVax-DV in Healthy Adults in Taiwan
The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan
- Conditions
- Dengue
- Being tested
- TV003, Placebo for TV003
- Keywords
- Dengue Vaccine
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV003Biological
Live attenuated virus vaccine-TetraVax-DV
Placebo for TV003Biological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TV003 | Experimental | Live Attenuated Virus Vaccine-TetraVax-DV Receives: Biological: TV003 |
| Placebo for TV003 | Placebo comparator | Placebo Receives: Biological: Placebo for TV003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)
Determination of the serum PRNT50 to each virus type for each subject at study day 28, 56 and 90 post vaccination.
Measured: Up to Day 90 after vaccination
Secondary outcomes (9)
Immunogenicity of TetraVax-DV assessed by response rates
Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates.
Measured: Up to Day 90 after vaccination
Duration of immunogenicity of TetraVax-DV assessed by PRNT50
Assess the duration of the antibody response by measured serum PRNT50 to each virus type for each subject at study day 180 and day 365 post vaccination.
Measured: Up to Day 365 after vaccination
Frequency of viremia following vaccination
Measured: Up to Day 15 after vaccination
Quantity of viremia following vaccination
Measured: Up to Day 15 after vaccination
Duration of viremia following vaccination
Measured: Up to Day 15 after vaccination
Determine the number of vaccinees with recoverable dengue virus.
Measured: Up to Day 15 after vaccination
Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions.
Measured: Up to Day 7 after vaccination.
Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions.
Measured: Up to Day 21 after vaccination.
Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events.
Measured: Up to Day 365 after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start12 Dec 2017
- Primary completion10 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medigen Vaccine Biologics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Szu-Min Hsieh, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485144
- Sponsor's protocol ID
- CT-DV-21
- Status last verified
- Aug 2019
- First submitted
- 2 Mar 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Immunogenicity and Safety of TetraVax-DV in Healthy Adults in Taiwan
- ClinicalTrials.gov ID
- NCT03485144
- Acronym / sponsor ID
- CT-DV-21
- Conditions
- Dengue
- Keywords
- Dengue Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medigen Vaccine Biologics Corp.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 2 Apr 2018 (actual)
- 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.
The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TV003 | Experimental | Biological: TV003Live Attenuated Virus Vaccine-TetraVax-DV |
| Placebo for TV003 | Placebo comparator | Biological: Placebo for TV003Placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male or female between 20 and 70 years of age
- Good general health as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study
- Willingness to sign the informed consent document
- Female of childbearing potential willing to use effective contraception for the duration of the trial
Key exclusion criteria (19 listed)
- Females currently pregnant, as determined by positive β- human choriogonadotropin (HCG) test, and/or breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, or psychiatric disease
- Below lower limit of normal for absolute neutrophil count
- Any significant alcohol or drug abuse in the past 12 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 |
|---|---|---|
| TV003Live attenuated virus vaccine-TetraVax-DV | Biological | TV003 |
| Placebo for TV003Placebo | Biological | Placebo for TV003 |
Primary outcome
Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)
Time frame: Up to Day 90 after vaccination
Determination of the serum PRNT50 to each virus type for each subject at study day 28, 56 and 90 post vaccination.
9 secondary outcomes
Immunogenicity of TetraVax-DV assessed by response rates
Time frame: Up to Day 90 after vaccination
Duration of immunogenicity of TetraVax-DV assessed by PRNT50
Time frame: Up to Day 365 after vaccination
Frequency of viremia following vaccination
Time frame: Up to Day 15 after vaccination
Quantity of viremia following vaccination
Time frame: Up to Day 15 after vaccination
Duration of viremia following vaccination
Time frame: Up to Day 15 after vaccination
Determine the number of vaccinees with recoverable dengue virus.
Time frame: Up to Day 15 after vaccination
Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions.
Time frame: Up to Day 7 after vaccination.
Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions.
Time frame: Up to Day 21 after vaccination.
Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events.
Time frame: Up to Day 365 after vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
Szu-Min Hsieh, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TV003 in people with Dengue, run by Medigen Vaccine Biologics Corp. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 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 14 Aug 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50) (time frame: Up to Day 90 after vaccination). 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 14 Aug 2019.