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DenguePhase 2NCT02678455

Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

A Phase 2 study testing TV005 vaccine in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh. 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?
TV005 vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
192 participants
Where
1 siteBangladesh
Study dates
Mar 2016to 5 Feb 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 males or females (non-pregnant or lactating) between the ages of 12 months and 50 years at the time of enrollment into the study.
  • Reside in Mirpur Wards 2, 3, or 5 (or other Wards within Mirpur as designated by the PI if needed to reach enrollment targets) at the time of screening.
  • Study participants and/or their parents/guardians/legally acceptable or authorized representatives (LARs) who the Investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits).
  • Good general health as determined by physical examination, laboratory screening, and review of medical history.
  • If the participant is greater than or equal to 18 years of age, an informed consent form signed and dated by the study participant (and by an independent witness if required by local regulations). If the study participant is a minor, an assent form (for participants age 11-17 years) and informed consent form signed and dated by the participant's properly identified parent(s) or legally acceptable representative. If a participant is less than 11 years of age, the participant's parent(s) or legally acceptable representative will consent by signing the consent form for minor participants.
  • If the participant is female, she must not be pregnant or planning to become pregnant up to 28 days post vaccination. Female participants under the age of 18 will be enrolled, if they have not yet reached menarche. Females 18 years of age or older, must be properly using a method of pregnancy prevention that is known to be highly effective per the PI. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (greater than or equal to 6 months since last sexual encounter). For female study participants who are 18 years of age or older pregnancy testing will occur at screening and again before vaccination and they must have a negative pregnancy test prior to vaccination. Additionally, they will receive counselling on the importance of effective contraception during the 30 days prior to vaccination and continuing up to Day 28. Counselling will occur at their screening visit, on all clinic visit days up to Day 28. Female participants 18 years of age and older will be subject to pregnancy testing on the Study Day 28 and 56 visits. If female participants under the age of 18 that have not yet reached menarche prior to enrollment, reach menarche during the study, they will continue to be enrolled and followed-up through the entire three year follow-up period.

Who cannot join

  • Pregnant or lactating female or female planning to become pregnant within 28 days of receiving an investigational product or planning to discontinue abstinence or contraceptive precautions within 28 days of receiving an investigational product. Menstruating females under the age of 18 will be excluded from being enrolled.
  • 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 behavioural 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.
  • Having a height-for-age z-score (HAZ) or weight-for-age z-score (WAZ) of less than or equal to 3 for children under the age of two. Severe malnutrition as observed by the study physician for all study participants ages 2 years old and older.
  • Hepatitis C virus (HCV) infection by screening and confirmatory assays (screening in adults and adolescents only), or hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening (all participants) or, unwilling to allow HCV (adults and adolescents only) and HBV testing.
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  • Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine transaminase (ALT), or platelet count, as defined in this protocol.
  • For children under 5 years of age, screening laboratory values of Grade 1 or above for Haemoglobin.
  • History of allergic reaction likely to be exacerbated by any component of the vaccine; 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 participating in the trial or would render the participant unable to comply with the protocol.
  • Planned administration of any vaccine from 30 days prior to receipt of the study vaccine and ending 30 days after; with the exceptions of standard infant and child Expanded Program on Immunization (EPI) 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 receipt of study vaccine/placebo or planned use at any time during the study period or history of having received any investigational dengue vaccine at any previous time.
  • Current participation in any clinical or investigational study.
  • Administration of immunoglobulins and/or blood products within 90 days preceding the 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 full participation in the trial for the three year duration.
  • Potential adult volunteers or parents of potential child volunteers, who do not have easy access to a fixed or mobile telephone.
  • Any participant that resides in a household with an individual previously enrolled in an older age cohort in this study. Only one participant from each household will be enrolled.
  • 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 immediate family member (such as husband, wife and their children, adopted or natural) of the clinic employees or the Investigator.
  • Elimination Criteria During the Study:
  • The following criteria should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the participant from the study but may determine a participant's evaluability in the per-protocol (PP) analysis. The participant will continue to be evaluated for safety purposes at the regularly scheduled visits. See the protocol for definition of study cohorts to be evaluated.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/placebo during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
  • Administration of a licensed vaccine during the period starting from 30 days before dose of vaccine/placebo and ending 30 days after, with the exception of standard infant and childhood EPI "inactivated" vaccinations.
  • Administration of immunoglobulins and/or any blood products during the study period.
  • Pregnancy within the 28 days after investigational product administration.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    Mīrpur, Dhaka Division

Other trials in Bangladesh

About this study

Official title: Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixture TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

The purpose of this study is to evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh.

Read the detailed description

Dengue viruses (DENV) are the leading arboviral infection globally, with over 2 billion people at risk of infection worldwide. The first dengue fever outbreak in Bangladesh occurred in 2000, and since then, dengue fever has had a continued presence throughout Bangladesh. This study will evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh.

The study will enroll four cohorts of participants: adults, adolescents, children, and young children. Study researchers will evaluate study data for each cohort before enrolling the subsequent cohort.

Participants will be randomly assigned to receive either TV005 vaccine or placebo at study entry (Day 0). Additional study visits will occur on Days 7, 14, 28, 56, 180, 360, 720, and 1080. Study visits will include blood collection, physical examinations, and clinical assessments. Participants will record and monitor their temperature and symptoms until Day 14. Study staff will contact participants daily until Day 14; after Day 14, study staff will contact participants weekly (and after Day 180, monthly) throughout the study for follow-up health monitoring.

Conditions
Dengue
Being tested
TV005 vaccine, Placebo
Keywords
Dengue Virus
Medical subject headings
Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TV005 vaccineBiological

    Also called TetraVax-DV T005

    Delivered by subcutaneous injection; contains 10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31, and 10^3 PFU of rDEN4Δ30.

  • PlaceboBiological

    Delivered by subcutaneous injection

Study groups in NCT02678455
Study groupRoleWhat they receive
TV005 vaccineExperimentalParticipants will receive one dose of TV005 vaccine at study entry (Day 0).
Receives: Biological: TV005 vaccine
PlaceboPlacebo comparatorParticipants will receive one dose of placebo at study entry (Day 0).
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.

    Collected through daily home visits up to day 14, clinic visits for physical exam and hematological and blood chemistry labs, and weekly phone surveillance after day 14. Study staff record temperatures and AEs on the surveillance source document.

    Measured: Vaccine/placebo administration (study day 0) up to 28 days post vaccine/placebo administration

  2. Percentage of Study Participants Who Are Seropositive Following Vaccination

    Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 58, and 180 post vaccination. Seropositivity to each serotype as defined as PRNT50>=10.

    Per protocol analysis includes participants meeting eligibility criteria, complying with defined visits and protocols, no elimination criteria, and immunogenicity data endpoints measures available.

    Measured: Study day 14 through study day 180

Secondary outcomes (3)

  1. Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination

    Viremia in serum was determined both by amplification and direct titration using Vero cell monolayers. Each specific serotype was identified using monoclonal antibodies.

    Measured: Vaccine administration (study day 0) up to 14 days post vaccine administration

  2. Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.

    Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, and 180 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10.

    Measured: Study day 14 through study day 180

  3. Durability of Seropositivity Post TV005 Vaccination

    Estimated percent seropositive, over 3 years by age group and serotype. Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, 180, 360, 720, and 1080 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10.

    Measured: Vaccine/placebo administration (study day 0) up to three years post vaccine/placebo administration (study day 1080).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion10 Aug 2017
  4. Study completion5 Feb 2020

Resources

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
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02678455
Sponsor's protocol ID
PR-15097
Other IDs
Dengue TV005 in Dhaka
Status last verified
Feb 2024
First submitted
5 Feb 2016
Last updated
17 Jan 2025
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Podder G, Breiman RF, Azim T, Thu HM, Velathanthiri N, Mai le Q, Lowry K, Aaskov JG. Origin of dengue type 3 viruses associated with the dengue outbreak in Dhaka, Bangladesh, in 2000 and 2001. Am J Trop Med Hyg. 2006 Feb;74(2):263-5.

    PubMed 16474082

  • Kirkpatrick BD, Durbin AP, Pierce KK, Carmolli MP, Tibery CM, Grier PL, Hynes N, Diehl SA, Elwood D, Jarvis AP, Sabundayo BP, Lyon CE, Larsson CJ, Jo M, Lovchik JM, Luke CJ, Walsh MC, Fraser EA, Subbarao K, Whitehead SS. Robust and Balanced Immune Responses to All 4 Dengue Virus Serotypes Following Administration of a Single Dose of a Live Attenuated Tetravalent Dengue Vaccine to Healthy, Flavivirus-Naive Adults. J Infect Dis. 2015 Sep 1;212(5):702-10. doi: 10.1093/infdis/jiv082. Epub 2015 Mar 22.

    PubMed 25801652

  • Walsh MR, Alam MS, Pierce KK, Carmolli M, Alam M, Dickson DM, Bak DM, Afreen S, Nazib F, Golam K, Qadri F, Diehl SA, Durbin AP, Whitehead SS, Haque R, Kirkpatrick BD. Safety and durable immunogenicity of the TV005 tetravalent dengue vaccine, across serotypes and age groups, in dengue-endemic Bangladesh: a randomised, controlled trial. Lancet Infect Dis. 2024 Feb;24(2):150-160. doi: 10.1016/S1473-3099(23)00520-0. Epub 2023 Sep 27.

    PubMed 37776876

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TV005 vaccine in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Bangladesh.

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 6 inclusion and 26 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 17 Jan 2025. 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 Bangladesh. 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?

Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. (time frame: Vaccine/placebo administration (study day 0) up to 28 days post vaccine/placebo administration). 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 NCT02678455, which also lists 3 linked publications.

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 17 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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