NCT02873260

Brief Summary

This study will evaluate the ability of a single dose of the live attenuated recombinant tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005 vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

August 16, 2016

Last Update Submit

March 7, 2018

Conditions

Dengue

Keywords

Dengue Vaccine

Outcome Measures

Primary Outcomes (2)

  • Frequency of TV005 and rDEN3Δ30-related adverse events (AEs)

    As classified by both severity and seriousness, through active and passive surveillance

    Measured through Day 360

  • Frequency of viremia

    Measured through Day 360

Study Arms (2)

TetraVax-DV-TV005 + rDEN3Δ30

EXPERIMENTAL

Participants will receive the TetraVax-DV-TV005 vaccine at Day 0 and the rDEN3Δ30 virus at Day 180.

Biological: TetraVax-DV-TV005Biological: rDEN3Δ30

Placebo + rDEN3Δ30

PLACEBO COMPARATOR

Participants will receive placebo at Day 0 and the rDEN3Δ30 virus at Day 180.

Biological: rDEN3Δ30Biological: Placebo

Interventions

TetraVax-DV-TV005BIOLOGICAL

TetraVax-DV-TV005 contains 10\^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10\^4.3 PFU/mL of rDEN2/4Δ30(ME), 10\^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10\^3.3 PFU/mL of rDEN4Δ30. The vaccine is administered in 0.5 mL containing 10\^3.0 PFU of each component with the exception of rDEN2/4Δ30 that is given at a dose of 10\^4 PFU. TetraVax-DV-TV005 is administered by subcutaneous injection in the deltoid region of the upper arm.

Also known as: TV005
TetraVax-DV-TV005 + rDEN3Δ30
rDEN3Δ30BIOLOGICAL

Administered at a dose of 10\^4 PFU by subcutaneous injection in the deltoid region of the upper arm.

Placebo + rDEN3Δ30TetraVax-DV-TV005 + rDEN3Δ30
PlaceboBIOLOGICAL

Administered at a volume of 0.5 mL by subcutaneous injection in the deltoid region of the upper arm.

Placebo + rDEN3Δ30

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male or female between 18 and 50 years of age, inclusive.
  • Good general health as determined by physical examination, laboratory screening, and review of medical history.
  • Available for the duration of the study, approximately 26 weeks post-second inoculation.
  • Willingness to participate in the study as evidenced by signing the informed consent document.
  • Females Only: Female subjects of childbearing potential willing to use effective contraception. 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). All female subjects will be considered having child-bearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.

You may not qualify if:

  • Females Only: Currently pregnant, as determined by positive β-human choriogonadotropin (HCG) test, breast-feeding.
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
  • Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
  • Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol.
  • Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
  • Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history.
  • History of a severe allergic reaction or anaphylaxis.
  • Severe asthma (emergency room visit or hospitalization within the last 6 months).
  • HIV infection, by screening and confirmatory assays.
  • Hepatitis C virus (HCV) infection, by screening and confirmatory assays.
  • Hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening.
  • Any known immunodeficiency syndrome.
  • Current use of anticoagulant medications (this does not include anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
  • Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. Immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days.
  • Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination.
  • +36 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Immunization Research, Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

University of Vermont Testing Center

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

  • Pierce KK, Durbin AP, Walsh MR, Carmolli M, Sabundayo BP, Dickson DM, Diehl SA, Whitehead SS, Kirkpatrick BD. TV005 dengue vaccine protects against dengue serotypes 2 and 3 in two controlled human infection studies. J Clin Invest. 2024 Feb 1;134(3):e173328. doi: 10.1172/JCI173328.

    PMID: 37971871DERIVED

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Anna Durbin, MD

    Center for Immunization Research (CIR), Johns Hopkins School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

August 16, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 8, 2018

Record last verified: 2018-03

Locations

US(2)