Phase 2
N=90
Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine
Dengue · Dengue Fever · Dengue Hemorrhagic Fever
Bottom Line
View on ClinicalTrials.gov: NCT01943825 ↗Enrolled (actual)
90
Serious AEs
4.4%
Results posted
Feb 2020
Primary outcome: Primary: Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains — NA; NA; NA; NA titers (1/dilution)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CYD Dengue Vaccine (Biological); Japanese Encephalitis Vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains |
NA; NA; NA; NA; 6.1; 5.5 | — |
| PRIMARY Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains |
0; 0; 0; 0; 3; 1 | — |
| SECONDARY Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 |
NA; NA; 6.8; 7.4; 6.7; 7.2 | — |
| SECONDARY Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains |
5.8; 6.6; 8.6; 7.3; 13.9; 7.9 | — |
| SECONDARY Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia |
0; 0; 0; 1; 7; 5 | — |
| SECONDARY Number of Participants With Detectable Serotype-Specific Vaccine Viremia |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 |
NA; 22.9; 132.3; 620.9; 382.7; 501.8 | — |
| SECONDARY Number of Participants With Solicited Injection Site Reactions |
7; 6; 3; 6; 7; 4 | — |
| SECONDARY Number of Participants With Solicited Systemic Reactions |
2; 2; 3; 1; 10; 11 | — |
Summary
The aim of the study was to evaluate a compressed dosing schedule and the immunologic effects of co-administration of a CYD dengue vaccine with a licensed flavivirus (FV) with Japanese encephalitis (JE) vaccine.
Primary Objectives:
* To describe and compare the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.
* To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 after CYD dengue vaccine Dose 3, irrespective of whether or not JE vaccine had been previously administered.
Secondary Objectives:
* To describe the safety profile after each injection of CYD dengue vaccine.
* To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose when administered with or after JE virus vaccine in Groups 3 and 4.
* To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes at 6 months post-dose 3 in all four groups and at 12 months post-dose 3 in Groups 1 and 3 with the compressed schedule.
* To determine the level of viremia on Day (D)0, D3, D5, D7 and D14 following each CYD vaccine dose administered in Groups 1-4.
* To describe the JE humoral immune response at baseline and 28 days after each injection of CYD dengue vaccine in Groups 3 and 4.
Eligibility Criteria
Inclusion Criteria
- Aged greater than or equal to (>=)18 to less than or equal to ( ]12 months) in, or travel in the last 30 days to dengue endemic regions.
- Receipt of immune globulins, blood or blood-derived products in the 3 months prior to first vaccination or planned use during the study period.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceded 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the vaccine components (including protamine sulfate), 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.
- Excessive alcohol consumption or drug addiction.
- Chronic illness that, in the opinion of the Investigator, was 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.
- Temporary Exclusion Criteria: Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [>= 100.4 degree fahrenheit]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided. If the delay for the febrile illness exceeded the window between screening and vaccination, or if deemed necessary by the Investigator, a prospective participant might be re-screened once the fever had resolved.
Data sourced from ClinicalTrials.gov (NCT01943825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.