Phase 2
N=7
A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children
Dengue
Bottom Line
View on ClinicalTrials.gov: NCT01843621 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) — 16.7; 83.3; 16.7; 66.7 % of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DEN vaccine F17 (Biological)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Feb 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) |
16.7; 83.3; 16.7; 66.7; 50.0; 100 | — |
| PRIMARY Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) |
6.0; 28.2; 6.8; 18.0; 16.8; 94.4 | — |
| SECONDARY Solicited Local Adverse Events (AEs) Within 21 Day Follow-up |
3; 0; 3; 0; 4; 1 | — |
| SECONDARY Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination |
85.7; 14.3; 14.3; 42.9; 14.3; 28.6 | — |
| SECONDARY Serious Adverse Events (SAE) Within 31 Days Post Vaccination |
— | — |
| SECONDARY Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination |
42.9 | — |
| SECONDARY Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster |
16.67; 33.33; 0.00; 16.67; 0.00; 0.00 | — |
| SECONDARY Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose |
1 | — |
| SECONDARY Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) |
0; 0.3; 0; 0; 0.4; 0 | — |
| SECONDARY Subject Biochemistry and Hematology Parameters Monitored for Alert Levels |
15; 28; 494000; 37; 2820; 15 | — |
Summary
One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose
Eligibility Criteria
Inclusion Criteria
- Subjects who received two doses of DEN vaccine in the Dengue-003 study
- Subjects whos parents signed an informed consent form were eligible for participation in the five year follow-up study
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01843621). 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.