Prevention of Dengue FeverPhase 1NCT04035278
A Phase 1 Safety Study of Dengusiil in Healthy Adults
A Phase 1 study testing Dengusiil in people with Prevention of Dengue Fever, run by Serum Institute of India Pvt. Ltd. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Dengue Fever
- What is being tested?
- Dengusiil
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Dec 2019to 11 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: 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.
- Conditions
- Prevention of Dengue Fever
- Being tested
- Dengusiil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DengusiilBiological
Also called Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4)
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.
PlaceboBiological
Also called Lyophilized powder containing all the components of the vaccine except DENV serotypes 1, 2, 3 and 4
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.
| Study group | Role | What they receive |
|---|---|---|
| Dengusiil | Experimental | Not described Receives: Biological: Dengusiil |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local and systemic reactions
Measured: 21 days
Occurrence, severity, and relatedness to vaccination of unsolicited adverse events
Measured: 21 days
Occurrence, severity, and relatedness to vaccination of serious adverse events
Measured: 180 days
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Measured: 8 days
Proportion of participants with clinically significant physical examination and vital signs findings
Measured: 180 days
Secondary outcomes (6)
Proportion of participants with seroconversion for DENV-1 to 4 virus neutralization antibodies (PRNT50) titer
Measured: 84 days
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Measured: 84 days
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Measured: 180 days
Geometric mean titers (GMTs) of DENV-1 to 4 virus neutralization antibodies
Measured: 56 days
GMTs of DENV-1 to 4 virus neutralization antibodies
Measured: 84 days
Proportion of participants with viremia for each of DENV-1 to 4
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start17 Dec 2019
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of Dengue FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Australia Pty Ltd
- Responsible party
- Sponsor
- Investigators
- PRASAD KULKARNI, MD, Study director, SERUM INSTITUTE OF INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035278
- Sponsor's protocol ID
- Dengusiil-01
- Status last verified
- Dec 2023
- First submitted
- 25 Jul 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37532611
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double Blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Dengusiil in Healthy Adults
- ClinicalTrials.gov ID
- NCT04035278
- Acronym / sponsor ID
- Dengusiil-01
- Conditions
- Prevention of Dengue Fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PPD Australia Pty Ltd
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dengusiil | Experimental | Biological: Dengusiil |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DengusiilAlso: Live attenuated tetravalent vaccine containing all four dengue virus serotypes (DENV1, 2, 3 and 4)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. | Biological | Dengusiil |
| PlaceboAlso: Lyophilized powder containing all the components of the vaccine except DENV serotypes 1, 2, 3 and 4Placebo 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. | Biological | Placebo |
Primary outcome
Solicited local and systemic reactions
Time frame: 21 days
Occurrence, severity, and relatedness to vaccination of unsolicited adverse events
Time frame: 21 days
Occurrence, severity, and relatedness to vaccination of serious adverse events
Time frame: 180 days
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Time frame: 8 days
Proportion of participants with clinically significant physical examination and vital signs findings
Time frame: 180 days
6 secondary outcomes
Proportion of participants with seroconversion for DENV-1 to 4 virus neutralization antibodies (PRNT50) titer
Time frame: 84 days
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Time frame: 84 days
The percentage of participants seropositive for DENV-1 to 4 virus neutralizing antibodies
Time frame: 180 days
Geometric mean titers (GMTs) of DENV-1 to 4 virus neutralization antibodies
Time frame: 56 days
GMTs of DENV-1 to 4 virus neutralization antibodies
Time frame: 84 days
Proportion of participants with viremia for each of DENV-1 to 4
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Results publication: PubMed 37532611Gunale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PRASAD KULKARNI, MD study director
SERUM INSTITUTE OF INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dengusiil in people with Prevention of Dengue Fever, run by Serum Institute of India Pvt. Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited local and systemic reactions (time frame: 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.