Dengue VirusPhase 1NCT03141138
Comparison of Tetravalent Dengue Virus Purified Inactivated Vaccine and Tetravalent Dengue Virus Live Attenuated Vaccine
A Phase 1 study testing TDENV-PIV and TDENV-LAV F17 in people with Dengue Virus, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates given in the prime-boost regimen previously demonstrated to have a high level of immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare it with a previously untested schedule: Day 0 prime… Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Virus
- What is being tested?
- TDENV-PIV and TDENV-LAV F17
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 31 Dec 2021
- Phase
- Phase 1
- 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 18 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 42 years of age (inclusive) at the time of consent
- Able to provide written informed consent
- Healthy as established by medical history and clinical examination and basic hematologic laboratory analysis before entering into the study
- Able and willing to comply with the requirements of the protocol (eg, document events in memory aid, return for follow-up visits, etc.)
- Dengue exposure naïve as established by pre-enrollment dengue PRNT testing and questioning of volunteer
- Female subject of non-childbearing potential (non-childbearing potential is defined as having either a current bilateral tubal ligation at least 3 months prior to enrollment or a history of an hysterectomy, bilateral oophorectomy, or is post-menopause(12 months or more since last menstrual period)) or Female subject of childbearing potential may be enrolled in the study, if the subject has:
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- Practiced adequate contraception for 30 days prior to vaccinations, and
- A negative urine pregnancy test on each day of vaccination, and
- Agreed to continue adequate contraception through at least 3 months following last vaccination
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine or device) other than the study vaccines during the period starting 30 days preceding the first dose of study vaccine and/or planned use during the study period
- Chronic administration (defined as more than 14 days in total) of prescription immunosuppressants or other prescription immune-modifying drugs during the period starting 180 days prior to the first vaccine dose
- For corticosteroids, this will mean prednisone ≥ 20 mg/d or equivalent
- Inhaled and topical steroids are allowed
- History of or active use of cancer chemotherapy or radiation therapy for the treatment of cancer
- Receipt or planned receipt of a vaccine/product outside the study protocol within 30 days of each scheduled dose of an investigational product
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- Planned administration of any flavivirus vaccine, to include licensed vaccines for Yellow Fever or Japanese Encephalitis Virus as well as other investigational vaccines for dengue, Zika, West Nile, other flavivirus, for the entire study duration
- Previous receipt of a foreign or investigational dengue vaccine
- 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)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of, or current, auto-immune disease
- History of any reaction or hypersensitivity likely to be triggered by any component of the vaccines or related to a study procedure (This includes hypersensitivity reactions to alum, streptomycin, neomycin, or any other flavivirus vaccine, such as Yellow Fever virus and Japanese Encephalitis virus vaccines)
- Major congenital defects or serious chronic illness
- History of any chronic neurological disorders or chronic and/or uncontrolled seizures
- Acute infectious disease and/or fever (oral body temperature ≥ 100.4°F/38.0°C) at the time of enrollment (a subject with a minor illness, ie, 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 history, physical examination or laboratory screening tests
- Receipt of immunoglobulins or any blood products during the period starting 90 days preceding the first dose of study vaccine or planned receipt during the study period
- Donated blood within 8 weeks before first scheduled investigational vaccine receipt or planned donation of blood products throughout the study period
- History of chronic alcohol abuse and/or drug abuse that, in the opinion of the investigator, could result in poor compliance with study requirements.
- Pregnant or breastfeeding female or female planning to become pregnant or planning to discontinue contraceptive precautions
- A planned move to a location that will prohibit compliance with the requirements of the trial
- 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 that are outside the acceptable values at screening:
- > 110% upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, creatinine, serum urea nitrogen (SUN) and bilirubin (total and direct)
- < 100% lower limit of normal (LLN) or > 120% ULN for hemoglobin, hematocrit and platelet count
- < 75% LLN or >110% ULN for total white blood cell count (WBC) Note: Per guidance in section 8.1, abnormal lab(s) may be repeated x1 in the screening window provided the total amount of blood drawn for all screening labs does not exceed 50 mL.
- Active Diabetes or active peptic ulcer disease (PUD)
- Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from meeting all requirements of the study
- Chronic migraine headaches, defined as more than 15 headache days per month over a 3 month period of which more than 8 are migrainous, in the absence of medication over use
- Chronic medical condition that, in the opinion of the investigator, impacts subject safety
- Any other condition which, in the opinion of the investigator, prevents the subject from meeting all requirements of the study.
- Do not wish to have their blood stored and used for future research
Trial locations and contacts
1 site in 1 country.
United States1 site
WRAIR, Clinical Trials Center
Silver Spring, Maryland, 20910-7500
About this study
Official title: A Phase 1, Randomized, Open-label, Comparison of Heterologous Prime-Boost Vaccination Schedules of Tetravalent Dengue Virus Purified Inactivated Vaccine (PIV) and Tetravalent Dengue Virus Live Attenuated Vaccine (LAV) in Healthy Adults
This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates given in the prime-boost regimen previously demonstrated to have a high level of immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare it with a previously untested schedule: Day 0 prime (PIV) and Day 90 boost (LAV) in order to define the potential tradeoff between potential immunogenicity, including cell-mediated immunity, and a more practical dosing schedule.
Read the detailed description
This study is a Phase 1, randomized, open-label, study with 2 treatment groups (N=40):
Group 1 (n=20): TDENV-PIV 4 µg + Alum adjuvant (Day 0), TDENV-LAV F17 (Day 180) Group 2 (n=20): TDENV-PIV 4 µg + Alum adjuvant (Day 0), TDENV-LAV F17 (Day 90)
Investigational Product Dosage, Schedule, and Mode of Administration:
TDENV-PIV Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible TDENV-LAV F17 Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible Schedule Varied, 2 vaccinations per volunteer in a heterologous prime-boost strategy. First dose on Day 0 (PIV) AND a second dose (LAV) on Day 180 for group 1. First dose on Day 0 (PIV) AND a second dose (LAV) on Day 90 for group 2.
This study is intended to further evaluate the safety and reactogenicity of 2 tetravalent dengue vaccine (TDENV) candidates administered in a heterologous prime boost fashion with PIV followed by LAV 180 days later and to evaluate the safety and reactogenicity of a previously untested vaccination schedule consisting of PIV followed by LAV 90 days later.
- Conditions
- Dengue Virus
- Being tested
- TDENV-PIV, TDENV-LAV F17
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDENV-PIVBiological
Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible
TDENV-LAV F17Biological
Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: TDENV-PIV on Day 0 | Experimental | Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible Receives: Biological: TDENV-PIV |
| Group 1: TDENV-LAV F17 on Day 180 | Experimental | Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible Receives: Biological: TDENV-LAV F17 |
| Group 2: TDENV-PIV on Day 0 | Experimental | Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible Receives: Biological: TDENV-PIV |
| Group 2:TDENV-LAV F17 on Day 90 | Experimental | Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible Receives: Biological: TDENV-LAV F17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With At Least One Local Solicited Adverse Events (AE) during the 28 Day Follow-up After Prime and Boost Vaccinations
The number of subjects with at least one local solicited adverse event (AE), at least one general solicited AE and any solicited AE during the 28-day follow-up period for prime and boost vaccination will be tabulated with 95% confidence interval (CI) after each vaccine dose and overall.
Measured: 28 day follow-up period
Secondary outcomes (1)
Number of subjects reporting at least one of each type of unsolicited AE during the 28-day follow-up period after each vaccination
The number of subjects reporting at least one of each type of unsolicited AE during the 28-day follow-up period after each vaccination will be tabulated with 95% CIs
Measured: 28 day follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start8 Nov 2017
- Primary completion31 Oct 2019
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue VirusStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Simon D Pollett, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141138
- Sponsor's protocol ID
- S-16-23
- Status last verified
- Mar 2021
- First submitted
- 25 Apr 2017
- Last updated
- 26 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Comparison of Heterologous Prime-Boost Vaccination Schedules of Tetravalent Dengue Virus Purified Inactivated Vaccine (PIV) and Tetravalent Dengue Virus Live Attenuated Vaccine (LAV) in Healthy Adults
- ClinicalTrials.gov ID
- NCT03141138
- Acronym / sponsor ID
- S-16-23
- Conditions
- Dengue Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 May 2017 (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.
This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates given in the prime-boost regimen previously demonstrated to have a high level of immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare it with a previously untested schedule: Day 0 prime (PIV) and Day 90 boost (LAV) in order to define the potential tradeoff between potential immunogenicity, including cell-mediated immunity, and a more practical dosing schedule.
Detailed description
This study is a Phase 1, randomized, open-label, study with 2 treatment groups (N=40):
Group 1 (n=20): TDENV-PIV 4 µg + Alum adjuvant (Day 0), TDENV-LAV F17 (Day 180) Group 2 (n=20): TDENV-PIV 4 µg + Alum adjuvant (Day 0), TDENV-LAV F17 (Day 90)
Investigational Product Dosage, Schedule, and Mode of Administration:
TDENV-PIV Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible TDENV-LAV F17 Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible Schedule Varied, 2 vaccinations per volunteer in a heterologous prime-boost strategy. First dose on Day 0 (PIV) AND a second dose (LAV) on Day 180 for group 1. First dose on Day 0 (PIV) AND a second dose (LAV) on Day 90 for group 2.
This study is intended to further evaluate the safety and reactogenicity of 2 tetravalent dengue vaccine (TDENV) candidates administered in a heterologous prime boost fashion with PIV followed by LAV 180 days later and to evaluate the safety and reactogenicity of a previously untested vaccination schedule consisting of PIV followed by LAV 90 days later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: TDENV-PIV on Day 0 | Experimental | Biological: TDENV-PIVDosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible |
| Group 1: TDENV-LAV F17 on Day 180 | Experimental | Biological: TDENV-LAV F17Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible |
| Group 2: TDENV-PIV on Day 0 | Experimental | Biological: TDENV-PIVDosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible |
| Group 2:TDENV-LAV F17 on Day 90 | Experimental | Biological: TDENV-LAV F17Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female between 18 and 42 years of age (inclusive) at the time of consent
- Able to provide written informed consent
- Healthy as established by medical history and clinical examination and basic hematologic laboratory analysis before entering into the study
- Able and willing to comply with the requirements of the protocol (eg, document events in memory aid, return for follow-up visits, etc.)
- Dengue exposure naïve as established by pre-enrollment dengue PRNT testing and questioning of volunteer
Key exclusion criteria (32 listed)
- Use of any investigational or non-registered product (drug or vaccine or device) other than the study vaccines during the period starting 30 days preceding the first dose of study vaccine and/or planned use during the study period
- Chronic administration (defined as more than 14 days in total) of prescription immunosuppressants or other prescription immune-modifying drugs during the period starting 180 days prior to the first vaccine dose
- History of or active use of cancer chemotherapy or radiation therapy for the treatment of cancer
- Receipt or planned receipt of a vaccine/product outside the study protocol within 30 days of each scheduled dose of an investigational product
- Planned administration of any flavivirus vaccine, to include licensed vaccines for Yellow Fever or Japanese Encephalitis Virus as well as other investigational vaccines for dengue, Zika, West Nile, other flavivirus, 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-PIVDosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible | Biological | Group 1: TDENV-PIV on Day 0, Group 2: TDENV-PIV on Day 0 |
| TDENV-LAV F17Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible. | Biological | Group 1: TDENV-LAV F17 on Day 180, Group 2:TDENV-LAV F17 on Day 90 |
Primary outcome
Number of Subjects With At Least One Local Solicited Adverse Events (AE) during the 28 Day Follow-up After Prime and Boost Vaccinations
Time frame: 28 day follow-up period
The number of subjects with at least one local solicited adverse event (AE), at least one general solicited AE and any solicited AE during the 28-day follow-up period for prime and boost vaccination will be tabulated with 95% confidence interval (CI) after each vaccine dose and overall.
1 secondary outcome
Number of subjects reporting at least one of each type of unsolicited AE during the 28-day follow-up period after each vaccination
Time frame: 28 day follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Simon D Pollett principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TDENV-PIV and TDENV-LAV F17 in people with Dengue Virus, run by U.S. Army Medical Research and Development Command at 1 site 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 9 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. 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 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?
Results are not available in the source record.
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 Subjects With At Least One Local Solicited Adverse Events (AE) during the 28 Day Follow-up After Prime and Boost Vaccinations (time frame: 28 day follow-up period). 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 26 Mar 2021.