A Phase 1 Safety Study of Dengusiil in Healthy Adults

A Phase 1, Double Blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Dengusiil in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Prevention of Dengue Fever
• Intervention / Treatment: Biological: Dengusiil; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX Clinical Research Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: 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.; Other Names: Lyophilized powder containing all the components of the vaccine except DENV serotypes 1, 2, 3 and 4
Experimental: Dengusiil	Biological: 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.; Other Names: Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Solicited local and systemic reactions	21 days
Occurrence, severity, and relatedness to vaccination of unsolicited adverse events	21 days
Occurrence, severity, and relatedness to vaccination of serious adverse events	180 days
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings	8 days
Proportion of participants with clinically significant physical examination and vital signs findings	180 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with seroconversion for DENV-1 to 4 virus neutralization antibodies (PRNT50) titer	84 days
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies	84 days
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies	180 days
Geometric mean titers (GMTs) of DENV-1 to 4 virus neutralization antibodies	56 days
GMTs of DENV-1 to 4 virus neutralization antibodies	84 days
Proportion of participants with viremia for each of DENV-1 to 4	12 days

Collaborators and Investigators

• Sponsor: Serum Institute of India Pvt. Ltd.
• Collaborators: PPD Australia Pty Ltd
• Investigators: Study Director: PRASAD KULKARNI, MD, SERUM INSTITUTE OF INDIA

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): June 11, 2021
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Dengusiil-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No