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Clinical Trial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan

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ClinicalTrials.gov Identifier: NCT04133987
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Centers for Disease Control, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Phase II, randomized, double-blind, placebo-controlled study of the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 in the elderly in Taiwan

Condition or disease Intervention/treatment Phase
Dengue Biological: Tetravalent live attenuated dengue vaccine admixture TV005 Biological: Placebo Phase 2

Detailed Description:
In Taiwan, people who aged 50 to 70 years accounted for over 40% among those who infected by dengue virus every year. Therefore, to understanding the immunogenicity and safety of TV005 vaccine among people aged 50 to 70 years is important for whether TV005 can be introduced into Taiwan as a major intervention to control dengue. This trial is a phase II, double-blind, multicenter, and placebo-controlled one. The investigators plan to enroll 252 subjects whose age are 50 to 70 years at four study sites. One single-dose TV005 vaccine or placebo will be given subcutaneously. After vaccination, detailed data of the subjective symptoms, physical examination, laboratory examination, and titer of neutralization antibody from all subjects will be recorded. After completion of the present trial, the investigators can clarify the immunogenicity and safety of TV005 among people aged 50 to 70 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Phase II, Randomized, Double-blind, Clinical Tial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: Tetravalent live attenuated dengue vaccine admixture TV005
Tetravalent live attenuated dengue vaccine admixture TV005
Biological: Tetravalent live attenuated dengue vaccine admixture TV005
The admixtures of the candidate vaccines each contain 4 live attenuated dengue viruses, each of a different serotype.

Placebo Comparator: placebo
Plasma-Lyte A
Biological: Placebo
PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration.




Primary Outcome Measures :
  1. Proportion of study participants with solicited local and general adverse events. [ Time Frame: Measured through Day 21 ]
  2. Proportion of study participants with unsolicited adverse events. [ Time Frame: Measured through Day 29 ]
  3. Proportion of study participants with serious adverse events. [ Time Frame: Measured through Day 1080 ]
  4. Evaluation of the immunogenicity of TV005, as assessed by PRNT50 to DENV-1, DENV-2, DENV-3, and DENV-4 at 0, 28, 56, 72 and 180 days after TV005 vaccination [ Time Frame: Measured through Day 180 ]

Secondary Outcome Measures :
  1. Evaluation of the frequency and quantity of viremia of each monovalent component of the vaccine after vaccination. [ Time Frame: Measured through Day 21 ]
  2. Number of TV005 vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4. [ Time Frame: Measured through Day 72 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Man or non-pregnant / non-lactating woman between the ages of 50 years and 70 years at the time of enrollment into the study.
  2. Subjects 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).
  3. Subject who allow to access to their Medical Record.
  4. Subjects whose residence is in Taiwan who will remain available for the duration of the study, approximately 3 years following the first vaccination.
  5. Good general health as determined by physical examination, laboratory screening, and review of medical history.
  6. An informed consent form signed and dated by the subject.
  7. If the subject is female, she must be of non-childbearing potential, i.e. 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 90 days after completion of the vaccination. For male subject, he must be abstinent or use a condom together with spermicide for 14 days after completion of the vaccination.

Exclusion Criteria:

  1. Pregnant or lactating female or female planning to become pregnant within 90 days of receiving an investigational product or planning to discontinue abstinence or contraceptive precautions within 90 days of receiving an investigational product.
  2. Acute or chronic, clinically significant neurological, pulmonary, cardiovascular, hepatic, renal, autoimmune, hematologic, endocrine disease or functional defect, as determined by history, physical examination or screening tests that in the opinion of the investigator would, will jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
  3. Psychiatric, behavioral disorder, or seizures (with the exception of a single febrile seizure in childhood) that in the opinion of the investigator, will affect the ability of the subject to understand and cooperate with the requirements of the study protocol.
  4. Self-reported or suspected congenital or acquired immunodeficiency, or asplenia; 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, ≥ 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.
  5. HIV infection by screening (by HIV Ag/Ab combo test or HIV Ab test) and confirmatory assays (by Western blot), Hepatitis C virus (HCV) infection by Anti-HCV Ab, or Hepatitis B virus (HBV) infection by Hepatitis B surface antigen (HBsAg) screening or, unwilling to allow HIV, HCV and HBV testing.
  6. Screening laboratory values of hemoglobin <9.5 gm/dL in female adults or <11 gm/dL in male adults, neutrophil <1,000 mm3, platelet < 100,000/mm3, Creatinine >1.5 mg/dL, Bilirubin-T >1.5 times of upper limit, or ALT > 2 times of upper limit.
  7. 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.
  8. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures.
  9. 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.
  10. Planned administration of any vaccine not foreseen by the study protocol, during the period starting from 30 days before the study vaccine and ending 30 days after study vaccination; with the exceptions of the inactivated influenza vaccine or the inactivated rabies vaccine (without administration of immunoglobulin) administered.
  11. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the 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.
  12. Administration of immunoglobulins and/or blood products within 90 days preceding the study vaccine dose or planned administration at any time during the study period, which might interfere with assessment of the immune response. Or administration of killed vaccine within 14 days, or attenuated vaccine within 28 days.
  13. A planned or anticipated move to a location that will prohibit participating in the trial for the 12 month duration and unavailable for schedule visit during 2nd and 3rd year follow-up.
  14. Potential volunteers who do not have easy access to a fixed or mobile telephone.
  15. Any subject 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 family member (i.e., immediate, husband, wife and their children, adopted or natural) of the clinic employees or the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133987


Contacts
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Contact: Shan-Chwen Chang +886-2-2312-3456 ext 88002 changsc@ntu.edu.tw
Contact: Jann-Tay Wang +886-2-2312-3456 ext 63517 wang.jt1968@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Shan-Chwen Chang    +886-2-2312-3456 ext 88002    changsc@ntu.edu.tw   
Contact: Jann-Tay Wang    +886-2-2312-3456 ext 63517    wang.jt1968@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Centers for Disease Control, Taiwan

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04133987     History of Changes
Other Study ID Numbers: 201712180MSD
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
tetravalent dengue vaccine
Phase II clinical trial
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs