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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04035278




Registration number
NCT04035278
Ethics application status
Date submitted
25/07/2019
Date registered
29/07/2019
Date last updated
3/01/2024

Titles & IDs
Public title
A Phase 1 Safety Study of Dengusiil in Healthy Adults
Scientific title
A Phase 1, Double Blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Dengusiil in Healthy Adults
Secondary ID [1] 0 0
Dengusiil-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Dengue Fever 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Dengusiil
Treatment: Other - Placebo

Experimental: Dengusiil -

Placebo comparator: Placebo -


Treatment: Other: Dengusiil
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.

Treatment: Other: Placebo
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Solicited local and systemic reactions
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Occurrence, severity, and relatedness to vaccination of unsolicited adverse events
Timepoint [2] 0 0
21 days
Primary outcome [3] 0 0
Occurrence, severity, and relatedness to vaccination of serious adverse events
Timepoint [3] 0 0
180 days
Primary outcome [4] 0 0
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Timepoint [4] 0 0
8 days
Primary outcome [5] 0 0
Proportion of participants with clinically significant physical examination and vital signs findings
Timepoint [5] 0 0
180 days
Secondary outcome [1] 0 0
Proportion of participants with seroconversion for DENV-1 to 4 virus neutralization antibodies (PRNT50) titer
Timepoint [1] 0 0
84 days
Secondary outcome [2] 0 0
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Timepoint [2] 0 0
84 days
Secondary outcome [3] 0 0
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Timepoint [3] 0 0
180 days
Secondary outcome [4] 0 0
Geometric mean titers (GMTs) of DENV-1 to 4 virus neutralization antibodies
Timepoint [4] 0 0
56 days
Secondary outcome [5] 0 0
GMTs of DENV-1 to 4 virus neutralization antibodies
Timepoint [5] 0 0
84 days
Secondary outcome [6] 0 0
Proportion of participants with viremia for each of DENV-1 to 4
Timepoint [6] 0 0
12 days

Eligibility
Key inclusion criteria
1. Healthy adults aged 18-45, men, or women.
2. Seronegative for Dengue NS1 and IgM at screening indicating no current dengue infection
3. Seronegative for dengue IgG at screening
4. Participants who are willing to comply with the requirements of the study protocol and attend scheduled visits.
5. Participants who give written informed consent approved by the Human Research Ethics Committee (HREC) governing the site.
6. Participants must have the laboratory parameters within normal range.
7. Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
8. Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations those are acceptable for study entry.
9. Participants should agree to not:

1. donate blood for the purpose of blood transfusion
2. donate an organ for the purpose of transplantation
3. to share needles with other people
4. allow their blood to come in contact with another person's mucous membranes for 84 days post-vaccination.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous dengue vaccination.
2. 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
3. Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
4. Evidence or history of substance abuse including alcohol or previous substance abuse within the last year.
5. Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
6. Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing.
7. History of allergic disease, allergic reactions or known hypersensitivity to any component of the study vaccines.
8. Confirmed or suspected immunosuppressive or immune-deficient condition.
9. A family history of congenital or hereditary immunodeficiency.
10. 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.)
11. Laboratory confirmed infection with either hepatitis B virus (HBs Ag positive), hepatitis C virus (anti-HCV positive), or human immunodeficiency virus (HIV) at screening.
12. Known bleeding disorders.
13. 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.
14. Women who are pregnant, breast-feeding, or considering becoming pregnant.
15. 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/06/2021
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Serum Institute of India Pvt. Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
PPD Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04035278
Trial related presentations / publications
Gunale B, Farinola N, Yeolekar L, Shrivastava S, Girgis H, Poonawalla CS, Dhere RM, Arankalle V, Chandra Mishra A, Mehla R, Kulkarni PS. A Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a tetravalent live attenuated dengue vaccine in adults. Vaccine. 2023 Aug 31;41(38):5614-5621. doi: 10.1016/j.vaccine.2023.07.045. Epub 2023 Jul 31.
Public notes

Contacts
Principal investigator
Name 0 0
PRASAD KULKARNI, MD
Address 0 0
SERUM INSTITUTE OF INDIA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04035278