Immunogenicity and Safety of Different Vaccination Schedules of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age
NCT ID: NCT02628444
Last Updated: 2022-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1050 participants
INTERVENTIONAL
2016-05-02
2020-04-29
Brief Summary
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The primary objectives of the study were:
* To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants 28 days after the last injection.
* To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD vaccine given as a 3-dose schedule (Group 1) in previously dengue exposed participants, 1 year after the last injection.
* To demonstrate the non-inferiority of the immune response elicited against each dengue serotype elicited by a booster dose of CYD dengue vaccine one year or two years after the last injection in the primary series in previously dengue exposed participants, compared to the immune response post dose 3 in Group 1.
The secondary objectives of the study were:
* To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants, 28 days after the last injection.
* To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants, one year after the last injection.
* To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 3 to the antibody levels immediately before receiving a booster dose, by baseline dengue serostatus.
* To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 2 and 28 days post-injection 3 from Group 1 in a primary series schedule by baseline dengue serostatus.
* To demonstrate the superiority of the immune response elicited against each dengue serotype 28 days after administration of a booster dose of CYD dengue vaccine, in previously dengue exposed participants, at one year or two years after last injection in the primary series.
* To describe the seroconversion rate 28 days post-booster injection in all 3 groups.
* To describe all hospitalized virologically confirmed dengue (VCD) cases during the study.
* To evaluate the safety profile of CYD after each and any injection during the trial. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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STAGE-I Group 1: CYD Dengue Vaccine
Participants received 3 doses of CYD dengue vaccine 0.5 milliliters (mL) subcutaneously (SC) at Day 0 (Vaccination 1), Month 6 (Vaccination 2), and Month 12 (Vaccination 3).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12)
Participants received a dose of placebo at Day 0 (Vaccination 1) along with 2 doses of CYD dengue vaccine 0.5 mL SC at Month 6 (Vaccination 2) and Month 12 (Vaccination 3).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
Placebo (Sodium chloride 0.9%)
0.5 mL, Subcutaneous
STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)
Participants received 2 doses of placebo at Day 0 (Vaccination 1) and Month 6 (Vaccination 2) along with a dose of CYD dengue vaccine 0.5 mL SC at Month 12 (Vaccination 3).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
Placebo (Sodium chloride 0.9%)
0.5 mL, Subcutaneous
STAGE-II Group 1a: CYD Vaccine + CYD Booster Vaccine (1 Year)
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
STAGE-II Group 2a: Placebo + CYD + CYD Booster (1 Year)
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
Placebo (Sodium chloride 0.9%)
0.5 mL, Subcutaneous
STAGE-II Group 3a: Placebo + CYD + CYD Booster (1 Year)
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
Placebo (Sodium chloride 0.9%)
0.5 mL, Subcutaneous
STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years)
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years)
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
Placebo (Sodium chloride 0.9%)
0.5 mL, Subcutaneous
STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years)
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
CYD Dengue Vaccine
0.5 mL, Subcutaneous
Placebo (Sodium chloride 0.9%)
0.5 mL, Subcutaneous
Interventions
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CYD Dengue Vaccine
0.5 mL, Subcutaneous
Placebo (Sodium chloride 0.9%)
0.5 mL, Subcutaneous
Eligibility Criteria
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Inclusion Criteria
* Participant in good health, based on medical history and physical examination.
* Assent form or informed consent form (ICF) had been signed and dated by the participant (based on local regulations), and ICF had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
* Participant and parent(s)/legally acceptable representative(s) were able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
* Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure.
* Self-reported or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
* Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
* Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
* Previous vaccination against dengue disease with either the trial vaccine or another vaccine.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol abuse or drug addiction that, based on investigator's judgment, might interfere with the participant's ability to comply with trial procedures.
* Identified as a site employee of the Investigator, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife, and their children, adopted or natural) of the employees or the Investigator.
* A prospective participant must not be included in the study until the following conditions and/or symptoms were resolved:
* Febrile illness (temperature greater than or equal to \[\>=\] 38.0 degree Celsius) or moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
9 Years
50 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Investigational Site 102
Barranquilla, , Colombia
Investigational Site 101
Cali, , Colombia
Investigational Site 103
Medellín, , Colombia
Investigational Primary Site Muntinlupa 201_Satellite Site San Pablo 202
City of Muntinlupa, , Philippines
Investigational Site 203
Manila, , Philippines
Investigational Site 204
Manila, , Philippines
Countries
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References
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Coronel-Martinez DL, Park J, Lopez-Medina E, Capeding MR, Bonfanti AAC, Montalban MC, Ramirez I, Gonzales MLA, Zambrano B, Dayan G, Chen Z, Wang H, Bonaparte M, Rojas A, Ramirez JC, Verdan MA, Noriega F. Immunogenicity and safety of booster CYD-TDV dengue vaccine after alternative primary vaccination schedules in healthy individuals aged 9-50 years: a randomised, controlled, phase 2, non-inferiority study. Lancet Infect Dis. 2022 Jun;22(6):901-911. doi: 10.1016/S1473-3099(21)00706-4. Epub 2022 Mar 29.
Coronel-MartInez DL, Park J, Lopez-Medina E, Capeding MR, Cadena Bonfanti AA, Montalban MC, Ramirez I, Gonzales MLA, DiazGranados CA, Zambrano B, Dayan G, Savarino S, Chen Z, Wang H, Sun S, Bonaparte M, Rojas A, Ramirez JC, Verdan MA, Noriega F. Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9-50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study. Lancet Infect Dis. 2021 Apr;21(4):517-528. doi: 10.1016/S1473-3099(20)30767-2. Epub 2020 Nov 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1161-3242
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002854-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CYD65
Identifier Type: -
Identifier Source: org_study_id
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