A first in Human single-Center Study To Evaluate the effectiveness and Safety Of A Live Attenuated Dengue Vaccine (KD-382) In Healthy Adults
- Conditions
- Dengue FeverInfection - Other infectious diseasesInflammatory and Immune System - Normal development and function of the immune system
- Registration Number
- ACTRN12618001027202
- Lead Sponsor
- KM Biologics Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Male or female volunteers aged between 18 and 65 years (both inclusive) at the time
of screening.
2. Individuals in good health as determined by the outcome of medical history, physical
examination, and clinical judgement by the Investigator.
3. Be willing and able to give written informed consent to participate in this study.
4. Be willing and able to communicate with the Investigator and understand the
requirements of the study.
5. Provision of signed, written and dated informed consent for optional genetic research.
If a subject declines to participate in the genetic component of the study, there will be
no penalty or loss of benefit to the subject. The subject will not be excluded from
other aspects of the study described in this protocol.
Subjects will not be entered into this study if they meet any of the following criteria:
1.History of flavivirus (Dengue, Japanese Encephalitis, Zika, Yellow Fever, West e, Kunjin) infection or vaccination or prolonged habitation in a Dengue endemic area (continuously for more than 1 year).
2.Seropositivity to any of the 4 Dengue serotypes. Seropositivity is defined as a FRNT titer >/= 1:10.
3.Seropositivity to Japanese Encephalitis, Zika, Yellow Fever, West e virus, or Kunjin assessed by commercial Enzyme Linked Immune Sorbent Assay (ELISA).
4.Blood tests positive for human immunodeficiency virus (HIV) antibodies, hepatitis B virus (HBV) surface antigen or Hepatitis C virus (HCV) antibodies.
5.Malignancies (subjects with multiple basal cell cancers but who had their last basal cell cancer removed completely [confirmed pathologically] are allowed to be entered into this study).
6.Hematologic conditions that may lead to bleeding tendencies or abnormality in platelets, white blood cell count, and neutrophil count.
7.Body mass index > 40, regardless of comorbidities.
8.Autoimmune conditions (e.g., rheumatoid arthritis).
9.Taking more than 4 regular medications.
10.Participation in another clinical study of any investigational product (vaccine, drug, medical device) or medical procedure within 4 weeks from last study visit before screening.
11.Plan to participate in another clinical study from 4 weeks before screening until the end of the treatment period.
12.Plan to receive any vaccine from 4 weeks before screening until the end of the treatment period.
13.Have received blood or blood-derived products in the last 3 months before screening, which might interfere with assessment of the immune response.
14.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the last 6 months before screening; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the last 3 months before screening).
15.Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances.
16.Current alcohol abuse or drug addiction that might interfere with the ability to comply with study procedures.
17.Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
Subjects with any of the following conditions are allowed to be entered into this study:
•History of mild to moderate allergic reaction to food or medication and does not meet the exclusion criteria 15.
•Well-controlled hypertension, defined as < 140 mmHg systolic and < 90 mmHg diastolic blood pressure, using no more than 2 antihypertensive drugs, and have been on the same dose of antihypertensive for at least 3 months.
•Well-controlled diabetes, defined as the most recent HbA1c (performed within the last 3 months) < 6.5%, controlled with diet or on metformin alone.
•History of intermittent or mild persistent asthma but not requiring systemic corticosteroid therapy that falls under the exclusion criteria 14.
18.Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Safety Objective:<br>• To evaluate the safety and tolerability of KD-382 in flavivirus<br>antibody-naïve healthy adults<br>The Primary objective will be assessed using a diary card review and AE review by Investigator at site.<br>[Day 57. ];• To evaluate the immunogenicity of KD-382 as assessed by seroconversion rates for each serotype wild-type parental virus (i.e., dengue virus [DENV]1/03135, DENV2/99345, DENV3/16562 and DENV4/1036). This objective will be assessed by Serology samples for DENV FRNT .[Days 29 and 57.]
- Secondary Outcome Measures
Name Time Method •To evaluate the immunogenicity of KD-382 as assessed by geometric mean titer (GMT) of FRNT50, geometric mean ratio (GMR) of FRNT50, number of seroconverted serotypes (i.e., monovalent, bivalent, trivalent, or tetravalent) for each subject and effective boosting* rate.<br><br>*Effective boosting is defined as >/= 4-fold increase in FRNT50 from Day 29 to Day 57 for subjects with FRNT50 >/= 1:10 at Day 29. Blood samples for DENV FRNT for each serotype wild-type parental virus (i.e., DENV1/03135, DENV2/99345, DENV3/16562 and DENV4/1036) will be collected at screening, day 29, and day 57. [Number of seroconverted serotypes (i.e., monovalent, bivalent, trivalent,<br>or tetravalent) for each subject at Days 29 and 57.]