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| Name | Class |
|---|---|
| PPD Australia Pty Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dengusiil | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PRASAD KULKARNI, MD | SERUM INSTITUTE OF INDIA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Adelaide | South Australia | 5000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37532611 | Result | 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. |
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| 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. |
|
|
| 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 |