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

NCT02678455 | Completed Phase 2 Results DMC

• 2 other identifiers: PR-15097Dengue TV005 in Dhaka
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dengue

Keywords

Dengue Virus

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  Study day 14 through study day 180

Secondary Outcomes (3)

• Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination

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

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

  Study day 14 through study day 180

• Durability of Seropositivity Post TV005 Vaccination

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

Study Arms (2)

TV005 vaccine

EXPERIMENTAL

Participants will receive one dose of TV005 vaccine at study entry (Day 0).

Biological: TV005 vaccine

Placebo

PLACEBO COMPARATOR

Participants will receive one dose of placebo at study entry (Day 0).

Biological: Placebo

Interventions

TV005 vaccine BIOLOGICAL

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.

Also known as: TetraVax-DV T005

TV005 vaccine

Placebo BIOLOGICAL

Delivered by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 12 Months - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• University of Vermont: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Mīrpur, Dhaka Division, Bangladesh

Location

Related Publications (3)

• 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.

  PMID: 16474082 BACKGROUND

• 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.

  PMID: 25801652 BACKGROUND

• 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.

  PMID: 37776876 DERIVED

Related Links

• International Center for Diarrhoeal Diseases Research, Bangladesh

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Results Point of Contact

• Title: Beth Kirkpatrick MD
• Organization: University of Vermont

beth.kirkpatrick@med.uvm.edu

802-656-5822

Study Officials

• Rashidul Haque, MD

  Centre for Vaccine Sciences, International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

• Beth D. Kirkpatrick, MD

  Vaccine Testing Center, University of Vermont College of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: March 1, 2016
• Primary Completion: August 10, 2017
• Study Completion: February 5, 2020
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2024-02

Locations

BA (1)