A Phase 1 Safety Study of Dengusiil in Healthy Adults
Primary Purpose
Prevention of Dengue Fever
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Dengusiil
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Dengue Fever
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged 18-45, men, or women.
- Seronegative for Dengue NS1 and IgM at screening indicating no current dengue infection
- Seronegative for dengue IgG at screening
- Participants who are willing to comply with the requirements of the study protocol and attend scheduled visits.
- Participants who give written informed consent approved by the Human Research Ethics Committee (HREC) governing the site.
- Participants must have the laboratory parameters within normal range.
- Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
- Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations those are acceptable for study entry.
Participants should agree to not:
- donate blood for the purpose of blood transfusion
- donate an organ for the purpose of transplantation
- to share needles with other people
- allow their blood to come in contact with another person's mucous membranes for 84 days post-vaccination.
Exclusion Criteria:
- Previous dengue vaccination.
- Presence of acute infection in the preceding 14 days or presence of a temperature ≥ 38.0°C, or acute symptoms of infection greater than of "mild" severity on the scheduled date of first dosing
- Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
- Evidence or history of substance abuse including alcohol or previous substance abuse within the last year.
- Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
- Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing.
- History of allergic disease, allergic reactions or known hypersensitivity to any component of the study vaccines.
- Confirmed or suspected immunosuppressive or immune-deficient condition.
- A family history of congenital or hereditary immunodeficiency.
- Chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying agents within six months prior to administration of study vaccine. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day; topical or inhalable steroids are allowed.)
- Laboratory confirmed infection with either hepatitis B virus (HBs Ag positive), hepatitis C virus (anti-HCV positive), or human immunodeficiency virus (HIV) at screening.
- Known bleeding disorders.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccines or planned administration during the study period.
- Women who are pregnant, breast-feeding, or considering becoming pregnant.
- Any other condition, which in the opinion of the investigator, might interfere with the study objectives, jeopardize the safety or rights of the participant or making it unlikely the participant could complete the protocol.
Sites / Locations
- CMAX Clinical Research Pty Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dengusiil
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Solicited local and systemic reactions
Occurrence, severity, and relatedness to vaccination of unsolicited adverse events
Occurrence, severity, and relatedness to vaccination of serious adverse events
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Proportion of participants with clinically significant physical examination and vital signs findings
Secondary Outcome Measures
Proportion of participants with seroconversion for DENV-1 to 4 virus neutralization antibodies (PRNT50) titer
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Geometric mean titers (GMTs) of DENV-1 to 4 virus neutralization antibodies
GMTs of DENV-1 to 4 virus neutralization antibodies
Proportion of participants with viremia for each of DENV-1 to 4
Full Information
NCT ID
NCT04035278
First Posted
July 25, 2019
Last Updated
August 16, 2022
Sponsor
Serum Institute of India Pvt. Ltd.
Collaborators
PPD Australia Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04035278
Brief Title
A Phase 1 Safety Study of Dengusiil in Healthy Adults
Official Title
A Phase 1, Double Blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Dengusiil in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serum Institute of India Pvt. Ltd.
Collaborators
PPD Australia Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 1 study to assess safety and tolerability of a single subcutaneous dose of Dengusiil in healthy adults of 18 to 45 years of age. In this study, immune response to Dengusiil will also be assessed over a period of 6 months and vaccine viremia will also be assessed over a period of 12 days after administration of vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Dengue Fever
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dengusiil
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Dengusiil
Other Intervention Name(s)
Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4)
Intervention Description
Dengusiil is provided as lyophilized powder to be reconstituted with 0.5 mL sterile water for injection (sWFI).The reconstituted vaccine is injected as a single 0.5 mL subcutaneous (SC) dose.
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lyophilized powder containing all the components of the vaccine except DENV serotypes 1, 2, 3 and 4
Intervention Description
Placebo is supplied as a vial of lyophilized powder containing all the components of the vaccine except dengue virus serotypes (DENV1, 2, 3 and 4) to be reconstituted with 0.5 mL sterile water for injection (sWFI).The reconstituted product is injected as a single 0.5 mL subcutaneous (SC) dose.
Primary Outcome Measure Information:
Title
Solicited local and systemic reactions
Time Frame
21 days
Title
Occurrence, severity, and relatedness to vaccination of unsolicited adverse events
Time Frame
21 days
Title
Occurrence, severity, and relatedness to vaccination of serious adverse events
Time Frame
180 days
Title
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Time Frame
8 days
Title
Proportion of participants with clinically significant physical examination and vital signs findings
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Proportion of participants with seroconversion for DENV-1 to 4 virus neutralization antibodies (PRNT50) titer
Time Frame
84 days
Title
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Time Frame
84 days
Title
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Time Frame
180 days
Title
Geometric mean titers (GMTs) of DENV-1 to 4 virus neutralization antibodies
Time Frame
56 days
Title
GMTs of DENV-1 to 4 virus neutralization antibodies
Time Frame
84 days
Title
Proportion of participants with viremia for each of DENV-1 to 4
Time Frame
12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged 18-45, men, or women.
Seronegative for Dengue NS1 and IgM at screening indicating no current dengue infection
Seronegative for dengue IgG at screening
Participants who are willing to comply with the requirements of the study protocol and attend scheduled visits.
Participants who give written informed consent approved by the Human Research Ethics Committee (HREC) governing the site.
Participants must have the laboratory parameters within normal range.
Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations those are acceptable for study entry.
Participants should agree to not:
donate blood for the purpose of blood transfusion
donate an organ for the purpose of transplantation
to share needles with other people
allow their blood to come in contact with another person's mucous membranes for 84 days post-vaccination.
Exclusion Criteria:
Previous dengue vaccination.
Presence of acute infection in the preceding 14 days or presence of a temperature ≥ 38.0°C, or acute symptoms of infection greater than of "mild" severity on the scheduled date of first dosing
Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
Evidence or history of substance abuse including alcohol or previous substance abuse within the last year.
Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing.
History of allergic disease, allergic reactions or known hypersensitivity to any component of the study vaccines.
Confirmed or suspected immunosuppressive or immune-deficient condition.
A family history of congenital or hereditary immunodeficiency.
Chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying agents within six months prior to administration of study vaccine. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day; topical or inhalable steroids are allowed.)
Laboratory confirmed infection with either hepatitis B virus (HBs Ag positive), hepatitis C virus (anti-HCV positive), or human immunodeficiency virus (HIV) at screening.
Known bleeding disorders.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccines or planned administration during the study period.
Women who are pregnant, breast-feeding, or considering becoming pregnant.
Any other condition, which in the opinion of the investigator, might interfere with the study objectives, jeopardize the safety or rights of the participant or making it unlikely the participant could complete the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PRASAD KULKARNI, MD
Organizational Affiliation
SERUM INSTITUTE OF INDIA
Official's Role
Study Director
Facility Information:
Facility Name
CMAX Clinical Research Pty Ltd
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 1 Safety Study of Dengusiil in Healthy Adults
We'll reach out to this number within 24 hrs