NCT01436422

Brief Summary

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2011

Typical duration for phase_1

Geographic Reach
1 country

3 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, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

2.6 years

First QC Date

September 16, 2011

Last Update Submit

August 19, 2015

Conditions

Dengue

Keywords

Dengue VirusDengue FeverDengue VaccineDengue Hemorrhagic FeverDengue Shock Syndrome

Outcome Measures

Primary Outcomes (3)

  • Safety of two TetraVax-DV admixtures, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity

    Measured through Day 360

  • Immunogenicity of two TetraVax-DV admixtures, as assessed by neutralizing antibody titers to DEN1, DEN2, DEN3, and DEN4

    Monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates will be determined at 28, 56, and 90 days after each vaccination.

    Measured through Day 180 after each vaccination

  • Seropositivity in those vaccinees who remained seronegative to one or more DENV serotypes following the first vaccination and who recieved a second dose of vaccine given at Day 180

    Measured through Day 360

Secondary Outcomes (10)

  • Frequency of viremia following vaccination

    Measured through Day 360

  • Number of vaccinees infected with DEN1, DEN2, DEN3, and DEN4

    Measured through Day 360

  • Duration of the neutralizing antibody response 26 weeks after each vaccination

    Measured 26 weeks after each vaccination

  • Ability of a second dose of vaccine to boost serum neutralizing antibody titers by Day 270

    Measured at Day 270

  • Evaluate the phenotype of peripheral blood mononuclear cells at primary infection with the TetraVax-DV vaccine

    Measured through Day 360

  • +5 more secondary outcomes

Study Arms (3)

TetraVax-DV Vaccine - Admixture TV003

EXPERIMENTAL

Participants will receive the TetraVax-DV Vaccine - Admixture TV003 at Day 0 and Day 180.

Biological: TetraVax-DV Vaccine - Admixture TV003

TetraVax-DV Vaccine - Admixture TV005

EXPERIMENTAL

Participants will receive the TetraVax-DV Vaccine - Admixture TV005 at Day 0 and Day 180.

Biological: TetraVax-DV Vaccine - Admixture TV005

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

TetraVax-DV Vaccine - Admixture TV003BIOLOGICAL

One subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV003 (10\^3 PFU of rDEN1Δ30, 10\^3 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31-7164, and 10\^3 PFU of rDEN4Δ30)

TetraVax-DV Vaccine - Admixture TV003
TetraVax-DV Vaccine - Admixture TV005BIOLOGICAL

One subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV005 (10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31-7164, and 10\^3 PFU of rDEN4Δ30)

TetraVax-DV Vaccine - Admixture TV005
PlaceboBIOLOGICAL

One subcutaneous injection at Day 0 and Day 180 of placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • In 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-vaccination
  • Willing to participate in the study as evidenced by signing the informed consent document
  • Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial. More information on this criterion can be found in the protocol.

You may not qualify if:

  • Currently pregnant (as determined by positive beta-human choriogonadotropin \[HCG\] test) or breastfeeding
  • 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 participant 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 the protocol
  • 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
  • Any significant alcohol or drug abuse in the 12 months prior to study entry that has caused medical, occupational, or family problems, as indicated by a participant's history
  • History of a severe allergic reaction or anaphylaxis
  • Severe asthma (emergency room visit or hospitalization within the 6 months prior to study entry)
  • 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
  • Use of anticoagulant medications
  • Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 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 42 days following vaccination
  • +36 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center for Immunization Research, Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Fletcher Allen Health Care (FAHC), General Clinical Research Center (GCRC)

Burlington, Vermont, 05401, United States

Location

University of Vermont Vaccine Testing Center

Burlington, Vermont, 05405, United States

Location

Related Publications (4)

  • Bhamarapravati N, Sutee Y. Live attenuated tetravalent dengue vaccine. Vaccine. 2000 May 26;18 Suppl 2:44-7. doi: 10.1016/s0264-410x(00)00040-2.

    PMID: 10821973BACKGROUND

  • Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.

    PMID: 16553547BACKGROUND

  • Durbin AP, Kirkpatrick BD, Pierce KK, Schmidt AC, Whitehead SS. Development and clinical evaluation of multiple investigational monovalent DENV vaccines to identify components for inclusion in a live attenuated tetravalent DENV vaccine. Vaccine. 2011 Sep 23;29(42):7242-50. doi: 10.1016/j.vaccine.2011.07.023. Epub 2011 Jul 21.

    PMID: 21781997BACKGROUND

  • 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: 25801652DERIVED

MeSH Terms

Conditions

DengueSevere 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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 19, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

US(3)