DenguePhase 2NCT04133987
Clinical Trial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan
A Phase 2 study testing Tetravalent live attenuated dengue vaccine admixture TV005 in people with Dengue, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Phase II, randomized, double-blind, placebo-controlled study of the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 in the elderly in Taiwan Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Tetravalent live attenuated dengue 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
- 252 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2018to 30 Sep 2022
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or non-pregnant / non-lactating woman between the ages of 50 years and 70 years at the time of enrollment into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- Subject who allows to access to their Medical Record.
- Subjects whose residence is in Taiwan who will remain available for the duration of the study, approximately 3 years following the first vaccination.
- Good general health as determined by physical examination, laboratory screening, and review of medical history.
- An informed consent form signed and dated by the subject.
- If the subject is female, she must be of non-childbearing potential, i.e. surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; condom and spermicide combination, oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination, have a negative pregnancy test prior to vaccination and must agree to continue such precautions for 90 days after completion of the vaccination. For male subject, he must be abstinent or use a condom together with spermicide for 14 days after completion of the vaccination.
Who cannot join
- Pregnant or lactating female or female planning to become pregnant within 90 days of receiving an investigational product or planning to discontinue abstinence or contraceptive precautions within 90 days of receiving an investigational product.
- Acute or chronic, clinically significant neurological, pulmonary, cardiovascular, hepatic, renal, autoimmune, hematologic, endocrine disease or functional defect, as determined by history, physical examination or screening tests that in the opinion of the investigator would, will jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
- Psychiatric, behavioral disorder, or seizures (with the exception of a single febrile seizure in childhood) that in the opinion of the investigator, will affect the ability of the subject to understand and cooperate with the requirements of the study protocol.
- Self-reported or suspected congenital or acquired immunodeficiency, or asplenia; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent, ≥ 0.5 mg/kg/day or 20 mg/day, for more than 2 consecutive weeks within the past 3 months). Inhaled and topical steroids are allowed.
- HIV infection by screening (by HIV Ag/Ab combo test or HIV Ab test) and confirmatory assays (by Western blot), Hepatitis C virus (HCV) infection by Anti-HCV antibody, or Hepatitis B virus (HBV) infection by Hepatitis B surface antigen (HBsAg) screening or, unwilling to allow HIV, HCV and HBV testing.
- Screening laboratory values of hemoglobin <9.5 gm/dL in female adults or <11 gm/dL in male adults, neutrophil <1,000 mm3, platelet < 100,000/mm3, Creatinine >1.5 mg/dL, Bilirubin-T >1.5 times of upper limit, or ALT > 2 times of upper limit.
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- History of allergic disease/reaction likely to be exacerbated by any component of the vaccine, or any history of a severe allergic reaction or anaphylaxis.
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures.
- 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.
- Planned administration of any vaccine not foreseen by the study protocol, during the period starting from 30 days before the study vaccine and ending 30 days after study vaccination; with the exceptions of the inactivated influenza vaccine or the inactivated rabies vaccine (without administration of immunoglobulin) administered.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine/placebo or planned use at any time during the study period or history of having received any investigational dengue vaccine at any previous time.
- Administration of immunoglobulins and/or blood products within 90 days preceding the study vaccine dose or planned administration at any time during the study period, which might interfere with assessment of the immune response. Or administration of killed vaccine within 14 days, or attenuated vaccine within 28 days.
- A planned or anticipated move to a location that will prohibit participating in the trial for the 12-month duration and unavailable for schedule visit during 2nd and 3rd year follow-up.
- Potential volunteers who do not have easy access to a fixed or mobile telephone.
- Any subject identified as a site employee of the Investigator or study clinic, with direct involvement in the proposed study or other studies under the direction of that Investigator or study clinic, as well as any family member (i.e., immediate, husband, wife and their children, adopted or natural) of the clinic employees or the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Randomized, Double-blind, Clinical Tial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan
Phase II, randomized, double-blind, placebo-controlled study of the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 in the elderly in Taiwan
Read the detailed description
In Taiwan, people who aged 50 to 70 years accounted for over 40% among those who infected by dengue virus every year. Therefore, to understanding the immunogenicity and safety of TV005 vaccine among people aged 50 to 70 years is important for whether TV005 can be introduced into Taiwan as a major intervention to control dengue. This trial is a phase II, double-blind, multicenter, and placebo-controlled one. The investigators plan to enroll 252 subjects whose age are 50 to 70 years at four study sites. One single-dose TV005 vaccine or placebo will be given subcutaneously. After vaccination, detailed data of the subjective symptoms, physical examination, laboratory examination, and titer of neutralization antibody from all subjects will be recorded. After completion of the present trial, the investigators can clarify the immunogenicity and safety of TV005 among people aged 50 to 70 years.
- Conditions
- Dengue
- Being tested
- Tetravalent live attenuated dengue vaccine admixture TV005, Placebo
- Keywords
- tetravalent dengue vaccine, Phase II clinical trial
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetravalent live attenuated dengue vaccine admixture TV005Biological
The admixtures of the candidate vaccines each contain 4 live attenuated dengue viruses, each of a different serotype.
PlaceboBiological
PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration.
| Study group | Role | What they receive |
|---|---|---|
| Tetravalent live attenuated dengue vaccine admixture TV005 | Experimental | Tetravalent live attenuated dengue vaccine admixture TV005 Receives: Biological: Tetravalent live attenuated dengue vaccine admixture TV005 |
| placebo | Placebo comparator | Plasma-Lyte A Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study participants with solicited local and general adverse events.
Measured: Measured through Day 21
Proportion of study participants with unsolicited adverse events.
Measured: Measured through Day 29
Proportion of study participants with serious adverse events.
Measured: Measured through Day 1080
Evaluation of the immunogenicity of TV005, as assessed by PRNT50 to DENV-1, DENV-2, DENV-3, and DENV-4 at 28, 56, 72 and 180 days after TV005 vaccination
Measured: Measured through Day 180
Secondary outcomes (2)
Evaluation of the frequency and quantity of viremia of each monovalent component of the vaccine after vaccination.
Measured: Measured through Day 21
Number of TV005 vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4.
Measured: Measured through Day 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start15 Oct 2018
- Primary completion30 Apr 2020
- Study completion30 Sep 2022
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.
- More trials run by National Taiwan University HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133987
- Sponsor's protocol ID
- 201712180MSD
- Status last verified
- Jan 2023
- First submitted
- 23 Sep 2019
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-blind, Clinical Tial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan
- ClinicalTrials.gov ID
- NCT04133987
- Acronym / sponsor ID
- 201712180MSD
- Conditions
- Dengue
- Keywords
- tetravalent dengue vaccine, Phase II clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control, Taiwan
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 Oct 2019 (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.
Phase II, randomized, double-blind, placebo-controlled study of the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 in the elderly in Taiwan
Detailed description
In Taiwan, people who aged 50 to 70 years accounted for over 40% among those who infected by dengue virus every year. Therefore, to understanding the immunogenicity and safety of TV005 vaccine among people aged 50 to 70 years is important for whether TV005 can be introduced into Taiwan as a major intervention to control dengue. This trial is a phase II, double-blind, multicenter, and placebo-controlled one. The investigators plan to enroll 252 subjects whose age are 50 to 70 years at four study sites. One single-dose TV005 vaccine or placebo will be given subcutaneously. After vaccination, detailed data of the subjective symptoms, physical examination, laboratory examination, and titer of neutralization antibody from all subjects will be recorded. After completion of the present trial, the investigators can clarify the immunogenicity and safety of TV005 among people aged 50 to 70 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetravalent live attenuated dengue vaccine admixture TV005 | Experimental | Biological: Tetravalent live attenuated dengue vaccine admixture TV005Tetravalent live attenuated dengue vaccine admixture TV005 |
| placebo | Placebo comparator | Biological: PlaceboPlasma-Lyte A |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Man or non-pregnant / non-lactating woman between the ages of 50 years and 70 years at the time of enrollment into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- Subject who allows to access to their Medical Record.
- Subjects whose residence is in Taiwan who will remain available for the duration of the study, approximately 3 years following the first vaccination.
- Good general health as determined by physical examination, laboratory screening, and review of medical history.
Key exclusion criteria (15 listed)
- Pregnant or lactating female or female planning to become pregnant within 90 days of receiving an investigational product or planning to discontinue abstinence or contraceptive precautions within 90 days of receiving an investigational product.
- Acute or chronic, clinically significant neurological, pulmonary, cardiovascular, hepatic, renal, autoimmune, hematologic, endocrine disease or functional defect, as determined by history, physical examination or screening tests that in the opinion of the investigator would, will jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
- Psychiatric, behavioral disorder, or seizures (with the exception of a single febrile seizure in childhood) that in the opinion of the investigator, will affect the ability of the subject to understand and cooperate with the requirements of the study protocol.
- Self-reported or suspected congenital or acquired immunodeficiency, or asplenia; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent, ≥ 0.5 mg/kg/day or 20 mg/day, for more than 2 consecutive weeks within the past 3 months). Inhaled and topical steroids are allowed.
- HIV infection by screening (by HIV Ag/Ab combo test or HIV Ab test) and confirmatory assays (by Western blot), Hepatitis C virus (HCV) infection by Anti-HCV antibody, or Hepatitis B virus (HBV) infection by Hepatitis B surface antigen (HBsAg) screening or, unwilling to allow HIV, HCV and HBV testing.
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 |
|---|---|---|
| Tetravalent live attenuated dengue vaccine admixture TV005The admixtures of the candidate vaccines each contain 4 live attenuated dengue viruses, each of a different serotype. | Biological | Tetravalent live attenuated dengue vaccine admixture TV005 |
| PlaceboPLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. | Biological | placebo |
Primary outcome
Proportion of study participants with solicited local and general adverse events.
Time frame: Measured through Day 21
Proportion of study participants with unsolicited adverse events.
Time frame: Measured through Day 29
Proportion of study participants with serious adverse events.
Time frame: Measured through Day 1080
Evaluation of the immunogenicity of TV005, as assessed by PRNT50 to DENV-1, DENV-2, DENV-3, and DENV-4 at 28, 56, 72 and 180 days after TV005 vaccination
Time frame: Measured through Day 180
2 secondary outcomes
Evaluation of the frequency and quantity of viremia of each monovalent component of the vaccine after vaccination.
Time frame: Measured through Day 21
Number of TV005 vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: Measured through Day 72
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 18 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tetravalent live attenuated dengue vaccine admixture TV005 in people with Dengue, run by National Taiwan University Hospital 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 7 inclusion and 15 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 Jan 2023. 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?
Proportion of study participants with solicited local and general adverse events. (time frame: Measured through Day 21). The study lists 4 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 Jan 2023.