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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05507450




Registration number
NCT05507450
Ethics application status
Date submitted
17/08/2022
Date registered
19/08/2022
Date last updated
20/05/2024

Titles & IDs
Public title
Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)
Scientific title
A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENV?30 [Live, Attenuated]) in Healthy Adults
Secondary ID [1] 0 0
V181-003
Secondary ID [2] 0 0
V181-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dengue Disease 0 0
Dengue Virus 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 - V181 High-Potency Level
Treatment: Other - V181 Mid-Potency Level
Treatment: Other - V181 Low-Potency Level
Treatment: Other - Placebo

Experimental: V181 High-Potency Level Group - Participants will receive a single 0.5mL subcutaneous (SC) dose of V181 High-Potency vaccine.

Experimental: V181 Mid-Potency Level Group - Participants will receive a single 0.5mL SC dose of V181 Mid-Potency vaccine.

Experimental: V181 Low-Potency Level Group - Participants will receive a single 0.5mL SC dose of V181 Low-Potency vaccine.

Placebo comparator: Placebo - Participants will receive a single SC 0.5 mL dose of placebo.


Treatment: Other: V181 High-Potency Level
0.5 mL SC dose of V181 High-Potency vaccine

Treatment: Other: V181 Mid-Potency Level
0.5 mL SC dose of V181 Mid-Potency vaccine

Treatment: Other: V181 Low-Potency Level
0.5 mL SC dose of V181 Low-Potency vaccine

Treatment: Other: Placebo
0.5 mL SC dose of placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)
Timepoint [1] 0 0
Day 28 post-vaccination
Primary outcome [2] 0 0
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 28 days post-vaccination
Secondary outcome [1] 0 0
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Timepoint [1] 0 0
Up to 5 days post-vaccination
Secondary outcome [2] 0 0
Percentage of Participants With Solicited Systemic AEs
Timepoint [2] 0 0
Up to 28 days post-vaccination

Eligibility
Key inclusion criteria
* Male participants are eligible to participate if they agree to the following for at least 90 days after administration of study intervention: Abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is NOT women of child-bearing potential; or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or is abstinent from heterosexual intercourse as her preferred and usual lifestyle (abstinent on a long term and persistent basis), for at least 90 days after administration of study intervention. (Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Has known history of dengue or zika natural infection.
* Has an acute febrile illness (temperature =38.0°C [=100.4°F] oral or equivalent) occurring within 72 hours before receipt of study vaccine or placebo.
* Has a serious or progressive disease, including but not limited to cancer; uncontrolled diabetes; severe cardiac, renal, or hepatic insufficiency; or systemic autoimmune or neurologic disorder.
* Has known or suspected impairment of immunological function, including but not limited to congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, hematologic malignancy, or treatment for autoimmune diseases.
* Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access.
* Has a known hypersensitivity to any component of the study vaccine or placebo, or history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
* Has received a dose of any dengue vaccine (investigational or approved) before study entry, or plans to receive any dengue vaccine (investigational or approved) for the duration of the trial.
* Has received other licensed non-live vaccines within 14 days before receipt of study vaccine or placebo, or is scheduled to receive any licensed non-live vaccine within 28 days following receipt of study vaccine or placebo. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or placebo, or at least 28 days after receipt of study vaccine or placebo.
* Has received a licensed live vaccine within 28 days before receipt of study vaccine or placebo, or is scheduled to receive any live vaccine within 28 days following receipt of study vaccine or placebo.
* Has received systemic corticosteroids (equivalent of =2 mg/kg/day of prednisone or =20 mg/d for persons weighing >10 kg) for =14 consecutive days and has not completed treatment at least 30 days before study entry or is expected to receive systemic corticosteroids at aforementioned dose and duration within 28 days following receipt of study vaccine or placebo. (Note: Topical and inhaled/nebulized steroids are permitted.)
* Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination.
* Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, within 6 months before receipt of study vaccine or placebo, or plans to receive immunosuppressive therapies within 28 days following receipt of study vaccine or placebo.
* Has received a blood transfusion or blood products (including immunoglobulins) within 6 months before receipt of a study vaccine or placebo, or plans to receive a blood transfusion or blood products (including immunoglobulins) within 28 days following receipt of study vaccine or placebo.
* Has participated in another clinical study of an investigational product within 6 months before signing the informed consent, or plans to participate in another interventional clinical study at any time during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor.
* Has planned donation of blood, eggs, or sperm at any time from signing the informed consent through 90 days post-vaccination.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
7/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2024
Sample size
Target
Accrual to date
Final
1271
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney ( Site 0007) - Blacktown
Recruitment hospital [2] 0 0
Emeritus Research ( Site 0010) - Botany
Recruitment hospital [3] 0 0
USC Clinical Trials Moreton Bay ( Site 0001) - Morayfield
Recruitment hospital [4] 0 0
USC Clinical Trials Sunshine Coast ( Site 0005) - Sippy Downs
Recruitment hospital [5] 0 0
USC Clinical Trials Brisbane (South Bank) ( Site 0006) - South Brisbane
Recruitment hospital [6] 0 0
Emeritus Research ( Site 0009) - Camberwell
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
4506 - Morayfield
Recruitment postcode(s) [4] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Finland
State/province [7] 0 0
Mellersta Osterbotten
Country [8] 0 0
Finland
State/province [8] 0 0
Pirkanmaa
Country [9] 0 0
Finland
State/province [9] 0 0
Pohjois-Pohjanmaa
Country [10] 0 0
Finland
State/province [10] 0 0
Satakunta
Country [11] 0 0
Finland
State/province [11] 0 0
Sodra Osterbotten
Country [12] 0 0
Finland
State/province [12] 0 0
Uusimaa
Country [13] 0 0
Finland
State/province [13] 0 0
Varsinais-Suomi
Country [14] 0 0
Germany
State/province [14] 0 0
Bayern
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Israel
State/province [17] 0 0
Haifa
Country [18] 0 0
Israel
State/province [18] 0 0
Jerusalem
Country [19] 0 0
Israel
State/province [19] 0 0
Ramat Gan
Country [20] 0 0
Taiwan
State/province [20] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.
Trial website
https://clinicaltrials.gov/study/NCT05507450
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
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/NCT05507450