Evaluating the Safety of and Immune Response to a Dengue Vaccine (TV003) in Healthy Adults, Adolescents, and Children in Thailand

NCT02332733 | Completed Phase 2 DMC

• 1 other identifier: WRAIR 2041
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of and immune response to two doses of a dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in Thailand.

Conditions

Dengue

Outcome Measures

Primary Outcomes (4)

• Occurrence of solicited local and general adverse events (AEs) within the 21-day (Days 0-20) follow-up period after each vaccine dose

  AEs will be summarized by severity and relationship to vaccine by individuals and each group.

  Measured through Day 200

• Occurrence of unsolicited AEs within the 21-day (Days 0-20) follow-up period after each vaccine dose

  AEs will be summarized by severity and relationship to vaccine by individuals and each group.

  Measured through Day 200

• Occurrence of serious adverse events (SAEs) throughout the entire study period

  Measured through Day 360

• Serum plaque reduction neutralization titer 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses for each participant at baseline (Day 0) and Study Days 28, 56, 72, and 180 following each vaccination

  Monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates will be determined at these time points. Seroconversion will be defined as a 4-fold or greater rise in DENV-1, DENV-2, DENV-3, or DENV-4 neutralizing antibody titers by Day 72 compared with the pre-vaccination titer.

  Measured through Day 360

Secondary Outcomes (5)

• Frequency of viremia of each monovalent component of the vaccine after the first and second doses of vaccine

  Measured through Day 360

• Quantity of viremia of each monovalent component of the vaccine after the first and second doses of vaccine

  Measured through Day 360

• Duration of viremia of each monovalent component of the vaccine after the first and second doses of vaccine

  Measured through Day 360

• Number of vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4

  Measured through Day 360

• Duration of the antibody response in recipients of the tetravalent vaccine

  Measured through Day 360

Study Arms (2)

TV003 Vaccine

EXPERIMENTAL

Participants will receive a single injection of TV003 at Days 0 and 180.

Biological: TV003

Placebo vaccine for TV003

PLACEBO COMPARATOR

Participants will receive a single injection of placebo for TV003 at Days 0 and 180.

Biological: Placebo for TV003

Interventions

TV003 BIOLOGICAL

10\^3 plaque forming units (PFU) of rDEN1 delta 30, 10\^3 PFU of rDEN2/4 delta 30(ME), 10\^3 PFU of rDEN3 delta 30/31-7164, and 10\^3 PFU of rDEN4 delta 30 to be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants

TV003 Vaccine

Placebo for TV003 BIOLOGICAL

To be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants

Placebo vaccine for TV003

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 male or female participant between the ages of 12 months and 50 years at the time of enrollment into the study
• Residence within the greater Bangkok area for the entire duration of the study period with access to transportation to study site
• Participants and/or their parents/guardians 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)
• Participants who will remain available for the duration of the study, approximately 26 weeks post-second vaccination
• Good general health as determined by physical examination, laboratory screening, and review of medical history
• If the participant is a minor, an assent form (for participant age 7-17 years) and informed consent form signed and dated by minor and the participant's parent(s) or legally acceptable representative, respectively. If the participant is 18 years of age or older, an informed consent form signed and dated by the participant (and by an independent witness if required by local regulations)
• If the participant is female, she must be of non-childbearing potential (i.e., either pre-menarcheal, surgically sterilized, or one year post-menopausal), or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device, condom and spermicide combination, oral contraceptives or other equivalent hormonal contraception \[e.g., progestin implantable, cutaneous hormonal patch, or injectable contraceptives\]) for 30 days prior to vaccination, have a negative pregnancy test prior to vaccination, and must agree to continue such precautions for 60 days after completion of the vaccination series. Any child who begins menarche during the study period must follow the same precautions listed above, from menarche until 60 days after the second vaccine dose.

You may not qualify if:

• Pregnant or lactating female or female planning to become pregnant or planning to discontinue abstinence or contraceptive precautions
• 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 behavioral 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.
• Body weight less than 10 kg at the time of enrollment
• HIV infection by screening and confirmatory assays, hepatitis C virus (HCV) infection by screening and confirmatory assays, or hepatitis B virus (HBV) infection by hepatitis B surface antigen (HBsAg) screening
• Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), or platelet count, as defined in this protocol
• History of allergic disease/reaction likely to be exacerbated by any component of the vaccine; or 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 in the trial or would render the participant unable to comply with the protocol
• Planned administration of any vaccine not foreseen by the study protocol, during the period starting from 30 days before each dose of the study vaccine and ending 30 days after each dose; with the exceptions of standard infant and child 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 the first dose of study vaccine/placebo or planned use at any time during the study period
• Administration of immunoglobulins and/or blood products within 90 days preceding the first 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 participating in the trial for the full 12 month duration
• Potential adult participants or parents of potential child participants, who do not have easy access to a fixed or mobile telephone

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

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

Study Officials

• Veerachai Watanaveeradej, MD

  Phramongkutklao College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

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: January 6, 2015
• First Posted: January 7, 2015
• Study Start: November 1, 2014
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

TH (1)