DenguePhase 1/2NCT02421367
Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults
A Phase 1/2 study of Dengue, run by U.S. Army Medical Research and Development Command at 2 sites in United States.
Trial summary
This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Mar 2018
- Phase
- Phase 1/2
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be able to provide written informed consent.
- Subjects must be healthy as established by medical history and clinical examination at study entry
- 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, etc.)
- Subjects at WRAIR CTC must be able to pass Department of Defense (DoD) base entry requirements, including the possession of a valid government issued ID card.
- Male or non-pregnant, non-breastfeeding female between 20 and 49 years of age (inclusive) at the time of consent
- Female subjects of non-childbearing potential (non-childbearing potential is defined as having had one of the following: a tubal ligation at least 3 months prior to enrollment, a hysterectomy, an ovariectomy, or is post-menopausal).
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- Female subjects of childbearing potential may be enrolled in the study, if all of the following apply:
- Practiced adequate contraception (see Definition of Terms, section 5) for 30 days prior to vaccination
- Has a negative urine pregnancy test on the day of vaccination
- Agrees to continue adequate contraception until two months after completion of the vaccination series.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines/placebo during the period starting 30 days preceding the first dose of study vaccine/placebo and/or planned use during the study period
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone >=5mg/day or equivalent; inhaled, intranasal and topical steroids are allowed)
- Planned administration or administration of a vaccine/product not planned in the study protocol during the period starting 30 days prior to the first dose of vaccine/placebo until 30 days after the last dose of study vaccine/placebo (routine influenza vaccination will be allowed as long as it is not administered within 14 days of the vaccine/placebo, and will not lead to study exclusion although it should be reported to the PI)
- History of dengue infection or dengue illness, or history of flavivirus vaccination (e.g., yellow fever, tick-borne-encephalitis virus [TBEV], Japanese encephalitis, and dengue)
- Planned administration of any flavivirus vaccine for the entire study duration
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
- Family history of congenital or hereditary immunodeficiency
- Autoimmune disease or history of autoimmune disease
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine/placebo or related to a study procedure
- Major congenital defects or serious chronic illness
- History of any neurological disorders or seizures
- Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least 1 month) or narcolepsy; or history of narcolepsy in a subject's parent, sibling, or child
- Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of enrollment: note that a subject with a minor illness such as mild diarrhea, mild upper respiratory infection, etc., without fever, may be enrolled at the discretion of the investigator
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
- Administration of immunoglobulins and/or any blood products during the period starting 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period
- Recent history of chronic alcohol consumption (more than 2 drinks per day and/or drug abuse (based on subject reported history)
- Pregnant or breastfeeding female or female currently planning to become pregnant or planning to discontinue adequate contraception
- A planned move to a location that will prohibit participating in the trial until Study End for the participant
- Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
- Safety laboratory test results at screening that are deemed clinically significant or more than Grade 1 deviation from normal
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, Center for Vaccine Development,
Baltimore, Maryland, 21201
WRAIR, Clinical Trials Center
Silver Spring, Maryland, 20910-7500
About this study
Official title: A Phase 1/2, Randomized, Observer-blind Study of Varying Injection Schedules of a Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) With AS03B Adjuvant and Placebo in Healthy Adults in the US
This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.
- Conditions
- Dengue
- Being tested
- TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.Biological
Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)
| Study group | Role | What they receive |
|---|---|---|
| TDENV-PIV (0-1) | Experimental | The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.
The placebo is sodium chloride.
TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.
The intervention will be administered on Day 0 and Day 28. The placebo will be administered on Day 84 and Day 168. Receives: Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution. |
| TDENV-PIV (0-1-6) | Experimental | The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.
The placebo is sodium chloride.
TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.
The intervention will be administered on Day 0, Day 28, and Day 168. The placebo will be administered on Day 84. Receives: Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution. |
| TDENV-PIV (0-3) | Experimental | The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.
The placebo is sodium chloride.
TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.
The intervention will be administered on Day 84 and Day 168. The placebo will be administered on Day 0 and Day 28. Receives: Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of solicited local adverse events related to product
Measured: 7-day follow-up period after each dose
Intensity of solicited local adverse events related to product
Measured: 7-day follow-up period after each dose
Number of unsolicited adverse events related to product
Measured: 28-day follow-up period after each dose
Intensity of unsolicited adverse events related to product
Measured: 28-day follow-up period after each dose
Number of Grade 2 laboratory abnormalities
Measured: 7-day follow-up period after each dose
Number of Grade 3 laboratory abnormalities
Measured: 7-day follow-up period after each dose
Number of serious adverse events from day 0 through 28 days after the last dose
Measured: 7 months after first dose
Number of potential immune-mediated diseases from Day 0 through 28 days after the last dose
Measured: 7 months after first dose
Neutralizing antibody titers to each DENV type
Measured: Day 0 and 28 days after the second and third doses of TDENV-PIV
Number of general adverse events related to product
Measured: 7-day follow-up period after each dose
Intensity of solicited general adverse events related to product
Measured: 7-day follow-up period after each dose
Number of medically attended AEs related to product
Measured: Day 0 through 28 days after the last dose
Secondary outcomes (16)
Number of potential immune-mediated diseases from post Month 7 to Study End
Measured: 7 months after first dose to the end of study
Number of serious adverse events related to product
Measured: 7 months after first dose to the end of study
Neutralizing antibody titers to each DENV type
Measured: 56 days after the second dose of active vaccine
Seropositivity status for each DENV type
Measured: 28 days after the second dose of active vaccine for all groups
Number of medically attended AEs from post Month 7 to Study End
Measured: 7 months after first dose to the end of study
Neutralizing antibody titers to each DENV type for the TDENV-PIV (0-1-6) group
Measured: 56 days after the third dose of active vaccine
Neutralizing antibody titers to each DENV type
Measured: 4 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Measured: 6 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Measured: 9 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Measured: 12 months after the last dose of active vaccine
Seropositivity status for each DENV type for the TDENV-PIV (0-1-6) group
Measured: 28 days after the third dose of active vaccine
Seropositivity status for each DENV type for the TDENV-PIV (0-1-6) group
Measured: 56 days after the third dose of active vaccine
Seropositivity status for each DENV type
Measured: 4 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Measured: 6 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Measured: 9 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Measured: 12 months after the last dose of active vaccine for all groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Leyi Lin, M.D., Principal investigator, USAMRMC/WRAIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421367
- Sponsor's protocol ID
- S-14-13
- Other IDs
- WRAIR # 2195, 201658
- Status last verified
- Sep 2019
- First submitted
- 15 Apr 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lin L, Lyke KE, Koren M, Jarman RG, Eckels KH, Lepine E, McArthur MA, Currier JR, Friberg H, Moris P, Keiser PB, De La Barrera R, Vaughn DW, Paris RM, Thomas SJ, Schmidt AC. Safety and Immunogenicity of an AS03B-Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study. Am J Trop Med Hyg. 2020 Jul;103(1):132-141. doi: 10.4269/ajtmh.19-0738. Epub 2020 Apr 23.
PubMed 32342848
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Observer-blind Study of Varying Injection Schedules of a Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) With AS03B Adjuvant and Placebo in Healthy Adults in the US
- ClinicalTrials.gov ID
- NCT02421367
- Acronym / sponsor ID
- S-14-13
- Conditions
- Dengue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), GlaxoSmithKline
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 Apr 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.
This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TDENV-PIV (0-1) | Experimental | Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B. The placebo is sodium chloride. TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm. The intervention will be administered on Day 0 and Day 28. The placebo will be administered on Day 84 and Day 168. |
| TDENV-PIV (0-1-6) | Experimental | Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B. The placebo is sodium chloride. TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm. The intervention will be administered on Day 0, Day 28, and Day 168. The placebo will be administered on Day 84. |
| TDENV-PIV (0-3) | Experimental | Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B. The placebo is sodium chloride. TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm. The intervention will be administered on Day 84 and Day 168. The placebo will be administered on Day 0 and Day 28. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects must be able to provide written informed consent.
- Subjects must be healthy as established by medical history and clinical examination at study entry
- 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, etc.)
- Subjects at WRAIR CTC must be able to pass Department of Defense (DoD) base entry requirements, including the possession of a valid government issued ID card.
- Male or non-pregnant, non-breastfeeding female between 20 and 49 years of age (inclusive) at the time of consent
Key exclusion criteria (22 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines/placebo during the period starting 30 days preceding the first dose of study vaccine/placebo and/or planned use during the study period
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone >=5mg/day or equivalent; inhaled, intranasal and topical steroids are allowed)
- Planned administration or administration of a vaccine/product not planned in the study protocol during the period starting 30 days prior to the first dose of vaccine/placebo until 30 days after the last dose of study vaccine/placebo (routine influenza vaccination will be allowed as long as it is not administered within 14 days of the vaccine/placebo, and will not lead to study exclusion although it should be reported to the PI)
- History of dengue infection or dengue illness, or history of flavivirus vaccination (e.g., yellow fever, tick-borne-encephalitis virus [TBEV], Japanese encephalitis, and dengue)
- Planned administration of any flavivirus vaccine for the entire study duration
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 |
|---|---|---|
| TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type) | Biological | TDENV-PIV (0-1), TDENV-PIV (0-1-6), TDENV-PIV (0-3) |
Primary outcome
Number of solicited local adverse events related to product
Time frame: 7-day follow-up period after each dose
Intensity of solicited local adverse events related to product
Time frame: 7-day follow-up period after each dose
Number of unsolicited adverse events related to product
Time frame: 28-day follow-up period after each dose
Intensity of unsolicited adverse events related to product
Time frame: 28-day follow-up period after each dose
Number of Grade 2 laboratory abnormalities
Time frame: 7-day follow-up period after each dose
Number of Grade 3 laboratory abnormalities
Time frame: 7-day follow-up period after each dose
Number of serious adverse events from day 0 through 28 days after the last dose
Time frame: 7 months after first dose
Number of potential immune-mediated diseases from Day 0 through 28 days after the last dose
Time frame: 7 months after first dose
Neutralizing antibody titers to each DENV type
Time frame: Day 0 and 28 days after the second and third doses of TDENV-PIV
Number of general adverse events related to product
Time frame: 7-day follow-up period after each dose
Intensity of solicited general adverse events related to product
Time frame: 7-day follow-up period after each dose
Number of medically attended AEs related to product
Time frame: Day 0 through 28 days after the last dose
16 secondary outcomes
Number of potential immune-mediated diseases from post Month 7 to Study End
Time frame: 7 months after first dose to the end of study
Number of serious adverse events related to product
Time frame: 7 months after first dose to the end of study
Neutralizing antibody titers to each DENV type
Time frame: 56 days after the second dose of active vaccine
Seropositivity status for each DENV type
Time frame: 28 days after the second dose of active vaccine for all groups
Number of medically attended AEs from post Month 7 to Study End
Time frame: 7 months after first dose to the end of study
Neutralizing antibody titers to each DENV type for the TDENV-PIV (0-1-6) group
Time frame: 56 days after the third dose of active vaccine
Neutralizing antibody titers to each DENV type
Time frame: 4 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Time frame: 6 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Time frame: 9 months after the last dose of active vaccine
Neutralizing antibody titers to each DENV type
Time frame: 12 months after the last dose of active vaccine
Seropositivity status for each DENV type for the TDENV-PIV (0-1-6) group
Time frame: 28 days after the third dose of active vaccine
Seropositivity status for each DENV type for the TDENV-PIV (0-1-6) group
Time frame: 56 days after the third dose of active vaccine
Seropositivity status for each DENV type
Time frame: 4 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Time frame: 6 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Time frame: 9 months after the last dose of active vaccine for all groups
Seropositivity status for each DENV type
Time frame: 12 months after the last dose of active vaccine for all groups
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 25 Sep 2019.
- Derived from this study: PubMed 32342848Lin L, Lyke KE, Koren M, Jarman RG, Eckels KH, Lepine E, McArthur MA, Currier JR, Friberg H, Moris P, Keiser PB, De La Barrera R, Vaughn DW, Paris RM, Thomas SJ, Schmidt AC. Safety and Immunogenicity of an AS03B-Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study. Am J Trop Med Hyg. 2020 Jul;103(1):132-141. doi: 10.4269/ajtmh.19-0738. Epub 2020 Apr 23.
- 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.
Leyi Lin, M.D. principal investigator
USAMRMC/WRAIR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Dengue, run by U.S. Army Medical Research and Development Command 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 10 inclusion and 22 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 25 Sep 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 combined 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.
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?
Number of solicited local adverse events related to product (time frame: 7-day follow-up period after each dose). The study lists 12 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 NCT02421367, 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 25 Sep 2019.