- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488890
Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine
March 15, 2022 updated by: Sanofi Pasteur, a Sanofi Company
Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.
The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations.
Primary Objectives:
- To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in Group 1 (Month [M] 13) and Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been previously administered.
- To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in Group 1 (M18) and Group 2 (M12), irrespective of whether or not YF vaccine has been previously administered.
Secondary Objective:
- To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2, irrespective of whether or not YF vaccine has been previously administered.
- To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group 1 (N=60) and Group 2 (N=60), and in Group 3 (N=120).
- To describe by FV status at baseline the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each injection of CYD dengue vaccine in Groups 1, 2, and 3.
- To describe the safety profile after each injection of CYD dengue vaccine and/or YF vaccine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants were randomized to 4 different groups to receive either CYD dengue vaccine and/or YF vaccine.
Participants who already received YF vaccine prior to enrolment were randomized to one of the 2 groups receiving CYD dengue vaccine alone.
Participants were evaluated for immunogenicity, antibody persistence, reactogenicity and safety.
Study Type
Interventional
Enrollment (Actual)
390
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Alabaster, Alabama, United States, 35007
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California
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Sacramento, California, United States, 95816
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Florida
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Jacksonville, Florida, United States, 32216
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Maryland
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Silver Spring, Maryland, United States, 20910
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Missouri
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Springfield, Missouri, United States, 65802
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Nevada
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Las Vegas, Nevada, United States, 89104
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Utah
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West Jordan, Utah, United States, 84088
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged >= 18 to <= 45 years on the day of inclusion
- Informed consent form had been signed and dated
- Able to attend all scheduled visits and complied with all trial procedures
- For participants classified as YF positive (+) to be included in Groups 1 and 2, previous vaccination (3 months to 10 years) with YF vaccine confirmed by acceptable documentation.
Exclusion Criteria:
- Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
- Participation 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
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination
- For all participants classified as YF negative (-), any previous vaccination against Flavivirus (FV) diseases (including Japanese Encephalitis [JE], tick-borne encephalitis, and YF)
- For participants classified as YF+, previous vaccination against FV diseases except YF (including JE and tick-borne encephalitis)
- For all participants, any FV vaccination planned during the trial period outside the study protocol
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known 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 seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Self-reported history of FV infection (e.g., JE, Dengue, YF, West Nile), confirmed either clinically or serologically
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including dry natural latex
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Identified as an employee of the Investigator or study center, 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 employee or the Investigator
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C [>=100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Previous residence (> 12 months) in, or travel in the last 30 days to FV endemic regions
- History of thymic pathology (thymoma), thymectomy, or myasthenia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CYD Dengue vaccine: Group 1
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
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0.5 mL, Subcutaneous
Other Names:
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Experimental: CYD Dengue vaccine: Group 2
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
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0.5 mL, Subcutaneous
Other Names:
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Experimental: CYD Dengue and Yellow Fever vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
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0.5 mL, Subcutaneous
Other Names:
0.5 mL, Subcutaneous
Other Names:
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Active Comparator: Yellow Fever vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
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0.5 mL, Subcutaneous
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Time Frame: Pre-injection 1, 28 days and 6 months post-injection 3
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GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
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Pre-injection 1, 28 days and 6 months post-injection 3
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Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Time Frame: Pre-injection 1, 28 days and 6 months post-injection 3
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Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT.
Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
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Pre-injection 1, 28 days and 6 months post-injection 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Time Frame: Pre-injection 1 and 2 and 28 days post-injection 1 and 2
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GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.
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Pre-injection 1 and 2 and 28 days post-injection 1 and 2
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Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Time Frame: Pre-injection 1 and 2 and 28 days post-injection 1 and 2
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Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT.
Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
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Pre-injection 1 and 2 and 28 days post-injection 1 and 2
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Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Time Frame: Pre-injection 1 and 28 days post-injection 1
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GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50).
Groups 1 and 2 data was reported as pooled data.
YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution).
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Pre-injection 1 and 28 days post-injection 1
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Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Time Frame: Pre-injection 1 and 28 days post-injection 1
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Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT.
Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
Groups 1 and 2 data was reported as pooled data.
YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution).
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Pre-injection 1 and 28 days post-injection 1
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Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Time Frame: Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3
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GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.
FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result).
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Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3
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Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Time Frame: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3
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GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.
FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
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Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3
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Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Time Frame: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3
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Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT.
Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result).
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Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3
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Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Time Frame: Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3
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Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT.
Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
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Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3
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Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Time Frame: Within 7 days after any injection
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Solicited injection site reactions: Pain, Erythema, and Swelling.
Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 mm.
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Within 7 days after any injection
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Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Time Frame: Within 14 days after any injection
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Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia.
Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
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Within 14 days after any injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2011
Primary Completion (Actual)
September 27, 2013
Study Completion (Actual)
September 27, 2013
Study Registration Dates
First Submitted
December 6, 2011
First Submitted That Met QC Criteria
December 7, 2011
First Posted (Estimate)
December 8, 2011
Study Record Updates
Last Update Posted (Actual)
March 24, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Wounds and Injuries
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Body Temperature Changes
- Heat Stress Disorders
- Hyperthermia
- Fever
- Yellow Fever
- Hemorrhagic Fevers, Viral
- Dengue
- Severe Dengue
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- CYD51
- U1111-1122-1892 (Other Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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