DenguePhase 2NCT02332733
Evaluating the Safety of and Immune Response to a Dengue Vaccine (TV003) in Healthy Adults, Adolescents, and Children in Thailand
A Phase 2 study testing TV003 in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the safety of and immune response to two doses of a dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in Thailand. Read more about this study
- Who is it for?
- Ages 12 months to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- TV003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2014to 26 Oct 2018
- 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 12 months to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy male or female participant between the ages of 12 months and 50 years at the time of enrollment into the study
- Residence within the greater Bangkok area for the entire duration of the study period with access to transportation to study site
- Participants and/or their parents/guardians 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)
- Participants who will remain available for the duration of the study, approximately 26 weeks post-second vaccination
- Good general health as determined by physical examination, laboratory screening, and review of medical history
- If the participant is a minor, an assent form (for participant age 7-17 years) and informed consent form signed and dated by minor and the participant's parent(s) or legally acceptable representative, respectively. If the participant is 18 years of age or older, an informed consent form signed and dated by the participant (and by an independent witness if required by local regulations)
- If the participant is female, she must be of non-childbearing potential (i.e., either pre-menarcheal, 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 60 days after completion of the vaccination series. Any child who begins menarche during the study period must follow the same precautions listed above, from menarche until 60 days after the second vaccine dose.
Who cannot join
- Pregnant or lactating female or female planning to become pregnant or planning to discontinue abstinence or contraceptive precautions
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, autoimmune, hematologic, or endocrine disease or functional defect, as determined by history, physical examination, or screening tests
- History of any neurological, psychiatric, or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood
- Self-reported or suspected congenital or acquired immunodeficiency; 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, greater than or equal to 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.
- Body weight less than 10 kg at the time of enrollment
- HIV infection by screening and confirmatory assays, hepatitis C virus (HCV) infection by screening and confirmatory assays, or hepatitis B virus (HBV) infection by hepatitis B surface antigen (HBsAg) screening
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- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), or platelet count, as defined in this protocol
- 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 participant in the trial or would render the participant 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 each dose of the study vaccine and ending 30 days after each dose; with the exceptions of standard infant and child inactivated vaccines and the inactivated influenza vaccine or the inactivated rabies vaccine (without administration of immunoglobulin) administered to adults or children
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo or planned use at any time during the study period
- Administration of immunoglobulins and/or blood products within 90 days preceding the first dose or planned administration at any time during the study period, which might interfere with assessment of the immune response
- A planned or anticipated move to a location that will prohibit participating in the trial for the full 12 month duration
- Potential adult participants or parents of potential child participants, who do not have easy access to a fixed or mobile telephone
- Any participant 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, Placebo-Controlled Study of the Safety and Immunogenicity of Two Doses of the LID/NIAID Live-Attenuated Tetravalent Dengue Vaccine, TV003, Administered Six Months Apart, to Healthy Adults, Adolescents, and Children in Thailand
The purpose of this study is to evaluate the safety of and immune response to two doses of a dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in Thailand.
Read the detailed description
Dengue infection is a leading cause of illness and death in the tropics and subtropics. The infection is caused by any one of four types of the dengue virus. This study will evaluate the safety of and immunogenicity to a vaccine (called TV003) against all four types of the dengue virus in healthy adults, adolescents, and children aged 12 months to 50 years in Thailand.
Participants will be enrolled sequentially in four age groups (adults, adolescents, children, and young children), and researchers will evaluate safety data before enrolling each subsequent cohort. Each participant will be in the study for approximately 12 months.
At study entry (Day 0), participants will be randomly assigned to receive either the TV003 vaccine or a placebo vaccine for TV003. All participants will receive two doses of TV003 or placebo-the first dose at study entry (Day 0) and the second dose 6 months later on Day 180. Additional study visits will occur on Days 6, 9, 12, 15, 28, 56, 72, 186, 189, 192, 195, 208, 236, 252, and 360.
All study visits will include a medical history review and a physical exam. Select study visits will also include blood collection and a urine pregnancy test for participants of childbearing potential.
At the vaccination study visits, participants will remain in the clinic for approximately 30 minutes after each vaccination for observation and monitoring. For 20 days after each vaccination, participants will take their temperatures and record any symptoms. Throughout the entire study period, study researchers will monitor participants for suspected dengue infection.
- Conditions
- Dengue
- Being tested
- TV003, Placebo for TV003
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV003Biological
10^3 plaque forming units (PFU) of rDEN1 delta 30, 10^3 PFU of rDEN2/4 delta 30(ME), 10^3 PFU of rDEN3 delta 30/31-7164, and 10^3 PFU of rDEN4 delta 30 to be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants
Placebo for TV003Biological
To be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants
| Study group | Role | What they receive |
|---|---|---|
| TV003 Vaccine | Experimental | Participants will receive a single injection of TV003 at Days 0 and 180. Receives: Biological: TV003 |
| Placebo vaccine for TV003 | Placebo comparator | Participants will receive a single injection of placebo for TV003 at Days 0 and 180. Receives: Biological: Placebo for TV003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local and general adverse events (AEs) within the 21-day (Days 0-20) follow-up period after each vaccine dose
AEs will be summarized by severity and relationship to vaccine by individuals and each group.
Measured: Measured through Day 200
Occurrence of unsolicited AEs within the 21-day (Days 0-20) follow-up period after each vaccine dose
AEs will be summarized by severity and relationship to vaccine by individuals and each group.
Measured: Measured through Day 200
Occurrence of serious adverse events (SAEs) throughout the entire study period
Measured: Measured through Day 360
Serum plaque reduction neutralization titer 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses for each participant at baseline (Day 0) and Study Days 28, 56, 72, and 180 following each vaccination
Monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates will be determined at these time points. Seroconversion will be defined as a 4-fold or greater rise in DENV-1, DENV-2, DENV-3, or DENV-4 neutralizing antibody titers by Day 72 compared with the pre-vaccination titer.
Measured: Measured through Day 360
Secondary outcomes (5)
Frequency of viremia of each monovalent component of the vaccine after the first and second doses of vaccine
The mean peak of viremia, mean day of onset of viremia, and mean duration of viremia of each monovalent component within each age cohort will be calculated.
Measured: Measured through Day 360
Quantity of viremia of each monovalent component of the vaccine after the first and second doses of vaccine
The mean peak of viremia, mean day of onset of viremia, and mean duration of viremia of each monovalent component within each age cohort will be calculated.
Measured: Measured through Day 360
Duration of viremia of each monovalent component of the vaccine after the first and second doses of vaccine
The mean peak of viremia, mean day of onset of viremia, and mean duration of viremia of each monovalent component within each age cohort will be calculated.
Measured: Measured through Day 360
Number of vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4
Defined by recovery of vaccine virus from the blood or serum of a participant and/or seropositivity OR seroconversion to DENV
Measured: Measured through Day 360
Duration of the antibody response in recipients of the tetravalent vaccine
The PRNT50 to DENV-1, DENV-2, DENV-3, and DENV-4 will be determined for all specimens collected on Study Day 180 following each vaccination.
Measured: Measured through Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startNov 2014
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
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 Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Veerachai Watanaveeradej, MD, Principal investigator, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332733
- Sponsor's protocol ID
- WRAIR 2041
- Status last verified
- Dec 2018
- First submitted
- 6 Jan 2015
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of Two Doses of the LID/NIAID Live-Attenuated Tetravalent Dengue Vaccine, TV003, Administered Six Months Apart, to Healthy Adults, Adolescents, and Children in Thailand
- ClinicalTrials.gov ID
- NCT02332733
- Acronym / sponsor ID
- WRAIR 2041
- Conditions
- Dengue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2014
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of and immune response to two doses of a dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in Thailand.
Detailed description
Dengue infection is a leading cause of illness and death in the tropics and subtropics. The infection is caused by any one of four types of the dengue virus. This study will evaluate the safety of and immunogenicity to a vaccine (called TV003) against all four types of the dengue virus in healthy adults, adolescents, and children aged 12 months to 50 years in Thailand.
Participants will be enrolled sequentially in four age groups (adults, adolescents, children, and young children), and researchers will evaluate safety data before enrolling each subsequent cohort. Each participant will be in the study for approximately 12 months.
At study entry (Day 0), participants will be randomly assigned to receive either the TV003 vaccine or a placebo vaccine for TV003. All participants will receive two doses of TV003 or placebo-the first dose at study entry (Day 0) and the second dose 6 months later on Day 180. Additional study visits will occur on Days 6, 9, 12, 15, 28, 56, 72, 186, 189, 192, 195, 208, 236, 252, and 360.
All study visits will include a medical history review and a physical exam. Select study visits will also include blood collection and a urine pregnancy test for participants of childbearing potential.
At the vaccination study visits, participants will remain in the clinic for approximately 30 minutes after each vaccination for observation and monitoring. For 20 days after each vaccination, participants will take their temperatures and record any symptoms. Throughout the entire study period, study researchers will monitor participants for suspected dengue infection.
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 Vaccine | Experimental | Biological: TV003Participants will receive a single injection of TV003 at Days 0 and 180. |
| Placebo vaccine for TV003 | Placebo comparator | Biological: Placebo for TV003Participants will receive a single injection of placebo for TV003 at Days 0 and 180. |
Who may qualify
- Ages
- 12 months to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy male or female participant between the ages of 12 months and 50 years at the time of enrollment into the study
- Residence within the greater Bangkok area for the entire duration of the study period with access to transportation to study site
- Participants and/or their parents/guardians 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)
- Participants who will remain available for the duration of the study, approximately 26 weeks post-second vaccination
- Good general health as determined by physical examination, laboratory screening, and review of medical history
Key exclusion criteria (16 listed)
- Pregnant or lactating female or female planning to become pregnant or planning to discontinue abstinence or contraceptive precautions
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, autoimmune, hematologic, or endocrine disease or functional defect, as determined by history, physical examination, or screening tests
- History of any neurological, psychiatric, or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood
- Self-reported or suspected congenital or acquired immunodeficiency; 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, greater than or equal to 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.
- Body weight less than 10 kg at the time of enrollment
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 |
|---|---|---|
| TV00310^3 plaque forming units (PFU) of rDEN1 delta 30, 10^3 PFU of rDEN2/4 delta 30(ME), 10^3 PFU of rDEN3 delta 30/31-7164, and 10^3 PFU of rDEN4 delta 30 to be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants | Biological | TV003 Vaccine |
| Placebo for TV003To be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants | Biological | Placebo vaccine for TV003 |
Primary outcome
Occurrence of solicited local and general adverse events (AEs) within the 21-day (Days 0-20) follow-up period after each vaccine dose
Time frame: Measured through Day 200
AEs will be summarized by severity and relationship to vaccine by individuals and each group.
Occurrence of unsolicited AEs within the 21-day (Days 0-20) follow-up period after each vaccine dose
Time frame: Measured through Day 200
AEs will be summarized by severity and relationship to vaccine by individuals and each group.
Occurrence of serious adverse events (SAEs) throughout the entire study period
Time frame: Measured through Day 360
Serum plaque reduction neutralization titer 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses for each participant at baseline (Day 0) and Study Days 28, 56, 72, and 180 following each vaccination
Time frame: Measured through Day 360
Monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates will be determined at these time points. Seroconversion will be defined as a 4-fold or greater rise in DENV-1, DENV-2, DENV-3, or DENV-4 neutralizing antibody titers by Day 72 compared with the pre-vaccination titer.
5 secondary outcomes
Frequency of viremia of each monovalent component of the vaccine after the first and second doses of vaccine
Time frame: Measured through Day 360
Quantity of viremia of each monovalent component of the vaccine after the first and second doses of vaccine
Time frame: Measured through Day 360
Duration of viremia of each monovalent component of the vaccine after the first and second doses of vaccine
Time frame: Measured through Day 360
Number of vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4
Time frame: Measured through Day 360
Duration of the antibody response in recipients of the tetravalent vaccine
Time frame: Measured through Day 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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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.
Veerachai Watanaveeradej, MD principal investigator
Phramongkutklao College of Medicine and 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 National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Thailand.
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 16 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 5 Dec 2018. 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 Thailand. 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?
Occurrence of solicited local and general adverse events (AEs) within the 21-day (Days 0-20) follow-up period after each vaccine dose (time frame: Measured through Day 200). 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 5 Dec 2018.