A Phase 1 Safety Study of Dengusiil in Healthy Adults

NCT04035278 | Completed Phase 1

• 1 other identifier: Dengusiil-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention of Dengue Fever

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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

Study Arms (2)

Dengusiil

EXPERIMENTAL

Biological: Dengusiil

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Dengusiil BIOLOGICAL

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.

Also known as: Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4)

Dengusiil

Placebo BIOLOGICAL

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.

Also known as: Lyophilized powder containing all the components of the vaccine except DENV serotypes 1, 2, 3 and 4

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead
• PPD Australia Pty Ltd: collaborator

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

• 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.

  PMID: 37532611 RESULT

Study Officials

• PRASAD KULKARNI, MD

  SERUM INSTITUTE OF INDIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: December 17, 2019
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)