Dengue FeverPhase 1DPIV-002NCT01702857
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico)
A Phase 1 study testing Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant, Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant and Phosphate buffered saline in people with Dengue Fever, run by U.S. Army Medical Research and Development Command at 1 site in Puerto Rico.
Trial summary
This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV vaccine in a predominantly dengue-primed adult population. The study is designed to afford a first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine candidates, each formulated with a different… Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- What is being tested?
- Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant, Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant and Phosphate buffered saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Nov 2012to 23 Mar 2017
- 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 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
- A male or female between 20 and 39 years of age (inclusive) at the time of consent
- Written informed consent obtained from the subject
- Healthy subjects as established by medical history and clinical examination before entering into the study
- Subject has lived in the Caribbean for more than 10 years
- Female subjects of non-childbearing potential (non-childbearing potential is defined as having either a current tubal ligation at least three months prior to enrollment, hysterectomy, ovariectomy, or is post-menopause).
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- Female subjects of childbearing potential may be enrolled in the study, if the subject has:
- practiced adequate contraception for 30 days prior to vaccination, and
- a negative urine pregnancy test on the day of vaccination, and
- agreed 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 180 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent; inhaled and topical steroids are allowed)
- Planned administration or administration of a vaccine/product not foreseen by the study protocol during the Exclusion:
- 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 180 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent; inhaled and topical steroids are allowed)
- Planned administration or administration of a vaccine/product not foreseen by the study protocol during the period starting 30 days prior to the first dose of vaccine/placebo until after the visit at Day 56 (if influenza activity warrants vaccination of healthy young adults, influenza vaccination will be encouraged and will not lead to study exclusion)
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- Previous or planned administration of any other flavivirus vaccine (approved or investigational) for the entire study duration
- Previous receipt of any investigational dengue virus 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 (no laboratory testing required).
- Family history of congenital or hereditary immunodeficiency
- History of, or current auto-immune disease
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/placebo or related to a study procedure
- Major congenital defects or serious chronic illness
- History of any neurological disorders or seizures
- Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of enrollment (a subject with a minor illness, i.e., 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
- History of chronic alcohol consumption and/or drug abuse
- Pregnant or lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions
- 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 that are outside the normal limits for their age, gender, and locality at screening.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Clinical Research Center, 1st Floor University Hospital
San Juan, 00936-5067
About this study
Official title: A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of WRAIR Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in Puerto Rico
This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV vaccine in a predominantly dengue-primed adult population. The study is designed to afford a first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally, the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per each of the four DENV types. The control group will receive a saline placebo. All experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart. There is a parallel FTiH study that is conducted in the United States in a dengue-naive population using the same investigational vaccines.
- Conditions
- Dengue Fever
- Being tested
- Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant, Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant, Phosphate buffered saline, 1 µg TDENV-PIV with Alum adjuvant, 1 µg TDENV-PIV with AS01E adjuvant
- Keywords
- Dengue, Dengue fever, Dengue Hemorrhagic Fever, Flavivirus
- Medical subject headings
- Dengue, Severe Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvantBiological
Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvantBiological
Phosphate buffered salineOther
1 µg TDENV-PIV with Alum adjuvantBiological
1 µg TDENV-PIV with AS01E adjuvantBiological
| Study group | Role | What they receive |
|---|---|---|
| TDENV-PIV alum4 | Experimental | 4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days Receives: Biological: Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant |
| TDENV-PIV AS03B | Experimental | 1 µg TDENV-PIV with AS03B adjuvant; 0.5 mL intramuscular injection at 0 and 28 days Receives: Biological: Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant |
| Placebo | Placebo comparator | Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days Receives: Other: Phosphate buffered saline |
| TDENV-PIV alum1 | Experimental | 1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days Receives: Biological: 1 µg TDENV-PIV with Alum adjuvant |
| TDENV-PIV AS01E | Experimental | 1 µg TDENV-PIV with AS01E adjuvant; 0.5 mL intramuscular injection at 0 and 28 days Receives: Biological: 1 µg TDENV-PIV with AS01E adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and reactogenicity of various TDENV-PIV formulations from Day 0 through 28 days after the second dose (Day 0 - Day 56)
Safety and Reactogenicity:
- Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) during the 7-day follow-up period post each vaccination (Day 0-6)
- Occurrence, intensity and relationship to vaccination of unsolicited AEs during the 28-day follow-up period post each vaccination (Day 0-27)
- Hematological and biochemical levels at study visits on Days 0, 7, 28, 35 and 56
- Occurrence of serious adverse events (SAEs) from Day 0 to Day 56
- Occurrence of potential immune-mediated diseases (pIMDs) and medically attended AEs from Day 0 to Day 56
Measured: Up to Day 56
Humoral immunogenicity to each of four DENV types of various TDENV-PIV formulations 28 days after the second dose (Day 56)
Humoral Immunogenicity:
Neutralizing antibody titers specific to each DENV type at Day 56
- Geometric mean titers (GMTs) of neutralizing antibody titers to each DENV type
- Rate of fold increases in neutralizing antibody from Day 0 for each DENV type
- Seropositivity rates for each DENV type
- Trivalent and tetravalent seropositivity rates
Measured: Day 56
Secondary outcomes (3)
Safety of various TDENV-PIV formulations, from Day 0 to Month 13 (Visits 1-11)
Safety:
- Hematological and biochemical levels at study visits on Months 4, 7, 10 and Month 13
- Occurrence of pIMDs and medically attended AEs from Day 0 to Month 13
- Occurrence of any SAE from Day 0 to Month 13
Measured: Up to month 13
Humoral immunogenicity to each of four DENV types of various TDENV-PIV formulations on Days 0, 7 and 28 and Months 7 and 13
Humoral Immunogenicity:
- Geometric mean titers (GMTs) of neutralizing antibody titers to each DENV type
- Rate of fold increases in neutralizing antibody from Day 0 for each DENV type
- Seropositivity rates for each DENV type
- Trivalent and tetravalent seropositivity rates
Measured: Up to month 13
• To evaluate the safety of various TDENV-PIV formulations from Month 14 through the end of the study (Visit 15)
Occurrence of serious adverse events (SAEs) related to study procedures from Month 14 to end of study (Month 37-39)
Measured: Up to the end of study (Month 37-39)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startNov 2012
- Primary completion20 Jan 2017
- Study completion23 Mar 2017
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 Dengue FeverStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Clemente Diaz, MD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702857
- Sponsor's protocol ID
- S-12-12
- Other IDs
- 116614, WRAIR 1945, DPIV-002
- Acronym
- DPIV-002
- Status last verified
- May 2017
- First submitted
- 4 Oct 2012
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diaz C, Lin L, Martinez LJ, Eckels KH, Campos M, Jarman RG, De La Barrera R, Lepine E, Toussaint JF, Febo I, Innis BL, Thomas SJ, Schmidt AC. Phase I Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico. Am J Trop Med Hyg. 2018 May;98(5):1435-1443. doi: 10.4269/ajtmh.17-0627. Epub 2018 Mar 1.
PubMed 29512481
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of WRAIR Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in Puerto Rico
- ClinicalTrials.gov ID
- NCT01702857
- Acronym / sponsor ID
- DPIV-002 / S-12-12
- Conditions
- Dengue Fever
- Keywords
- Dengue, Dengue fever, Dengue Hemorrhagic Fever, Flavivirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)
- Study start
- Nov 2012 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 10 Oct 2012 (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 is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV vaccine in a predominantly dengue-primed adult population. The study is designed to afford a first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally, the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per each of the four DENV types. The control group will receive a saline placebo. All experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart. There is a parallel FTiH study that is conducted in the United States in a dengue-naive population using the same investigational vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TDENV-PIV alum4 | Experimental | Biological: Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days |
| TDENV-PIV AS03B | Experimental | Biological: Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant1 µg TDENV-PIV with AS03B adjuvant; 0.5 mL intramuscular injection at 0 and 28 days |
| Placebo | Placebo comparator | Other: Phosphate buffered salinePhosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days |
| TDENV-PIV alum1 | Experimental | Biological: 1 µg TDENV-PIV with Alum adjuvant1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days |
| TDENV-PIV AS01E | Experimental | Biological: 1 µg TDENV-PIV with AS01E adjuvant1 µg TDENV-PIV with AS01E adjuvant; 0.5 mL intramuscular injection at 0 and 28 days |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.)
- A male or female between 20 and 39 years of age (inclusive) at the time of consent
- Written informed consent obtained from the subject
- Healthy subjects as established by medical history and clinical examination before entering into the study
- Subject has lived in the Caribbean for more than 10 years
Key exclusion criteria (24 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 180 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent; inhaled and topical steroids are allowed)
- Planned administration or administration of a vaccine/product not foreseen by the study protocol during the Exclusion:
- 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 180 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent; inhaled and topical steroids are allowed)
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 |
|---|---|---|
| Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant | Biological | TDENV-PIV alum4 |
| Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant | Biological | TDENV-PIV AS03B |
| Phosphate buffered saline | Other | Placebo |
| 1 µg TDENV-PIV with Alum adjuvant | Biological | TDENV-PIV alum1 |
| 1 µg TDENV-PIV with AS01E adjuvant | Biological | TDENV-PIV AS01E |
Primary outcome
Safety and reactogenicity of various TDENV-PIV formulations from Day 0 through 28 days after the second dose (Day 0 - Day 56)
Time frame: Up to Day 56
Safety and Reactogenicity: * Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) during the 7-day follow-up period post each vaccination (Day 0-6) * Occurrence, intensity and relationship to vaccination of unsolicited AEs during the 28-day follow-up period post each vaccination (Day 0-27) * Hematological and biochemical levels at study visits on Days 0, 7, 28, 35 and 56 * Occurrence of serious adverse events (SAEs) from Day 0 to Day 56 * Occurrence of potential immune-mediated diseases (pIMDs) and medically attended AEs from Day 0 to Day 56
Humoral immunogenicity to each of four DENV types of various TDENV-PIV formulations 28 days after the second dose (Day 56)
Time frame: Day 56
Humoral Immunogenicity: Neutralizing antibody titers specific to each DENV type at Day 56 * Geometric mean titers (GMTs) of neutralizing antibody titers to each DENV type * Rate of fold increases in neutralizing antibody from Day 0 for each DENV type * Seropositivity rates for each DENV type * Trivalent and tetravalent seropositivity rates
3 secondary outcomes
Safety of various TDENV-PIV formulations, from Day 0 to Month 13 (Visits 1-11)
Time frame: Up to month 13
Humoral immunogenicity to each of four DENV types of various TDENV-PIV formulations on Days 0, 7 and 28 and Months 7 and 13
Time frame: Up to month 13
• To evaluate the safety of various TDENV-PIV formulations from Month 14 through the end of the study (Visit 15)
Time frame: Up to the end of study (Month 37-39)
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 23 May 2017.
- Derived from this study: PubMed 29512481Diaz C, Lin L, Martinez LJ, Eckels KH, Campos M, Jarman RG, De La Barrera R, Lepine E, Toussaint JF, Febo I, Innis BL, Thomas SJ, Schmidt AC. Phase I Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico. Am J Trop Med Hyg. 2018 May;98(5):1435-1443. doi: 10.4269/ajtmh.17-0627. Epub 2018 Mar 1.
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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.
Clemente Diaz, MD principal investigator
University of Puerto Rico
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 Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant, Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant and Phosphate buffered saline in people with Dengue Fever, run by U.S. Army Medical Research and Development Command at 1 site in Puerto Rico.
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 24 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 23 May 2017. 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 Puerto Rico. 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 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?
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?
Safety and reactogenicity of various TDENV-PIV formulations from Day 0 through 28 days after the second dose (Day 0 - Day 56) (time frame: Up to Day 56). The study lists 2 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 NCT01702857, 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 23 May 2017.