Phase 2
N=390
Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine
Dengue · Dengue Fever · Dengue Hemorrhagic Fever · Yellow Fever
Bottom Line
View on ClinicalTrials.gov: NCT01488890 ↗Enrolled (actual)
390
Serious AEs
3.3%
Results posted
Jun 2019
Primary outcome: Primary: 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 — 5.38; 5.13; 14.8; 15.9 Titers (1/dilution)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus (Biological); Yellow Fever (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5.38; 5.13; 14.8; 15.9; 13.3; 9.01 | — |
| PRIMARY Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 |
1.7; 2.5; 52.7; 56.5; 47.7; 32.7 | — |
| SECONDARY 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 |
5.38; 5.13; 10.3; 8.75; 11.2; 11.5 | — |
| SECONDARY 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 |
1.7; 2.5; 34.2; 24.6; 35.5; 35.6 | — |
| SECONDARY 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 |
5.19; 5.00; 8.71; 7.68; 5.06; 5.06 | — |
| SECONDARY 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 |
1.7; 0.0; 23.3; 20.4; 0.9; 0.9 | — |
| SECONDARY 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) |
5.73; 5.23; 14.3; 13.9; 9.25; 27.2 | — |
| SECONDARY 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) |
5.00; 5.00; 5.00; 7.31; 8.18; 7.50 | — |
| SECONDARY 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) |
3.2; 4.6; 18.2; 47.6; 26.6; 45.5 | — |
| SECONDARY 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) |
0.0; 0.0; 0.0; 18.5; 22.2; 19.4 | — |
| SECONDARY 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 |
44; 59; 51; NA; 0; 3 | — |
| SECONDARY 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 |
7; 5; 4; 1; 1; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Aged >= 18 to = 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.
Data sourced from ClinicalTrials.gov (NCT01488890). 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.