Phase 2
N=138
Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
Eastern Equine Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00584805 ↗Enrolled (actual)
138
Serious AEs
3.7%
Results posted
Sep 2019
Primary outcome: Primary: Subject Response Rates for PRNT80 Titers — 39; 28; 48; 79 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Inactivated, Dried, TSI-GSD 104, EEE (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Response Rates for PRNT80 Titers |
39; 28; 48; 79; 24; 9 | — |
| PRIMARY Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers |
8; 4; 10; 12; 5; 2 | — |
| PRIMARY Response Rates of Pre-Month 6 PRNT80 Titers |
7; 3; 8; 6; 3; 1 | — |
| PRIMARY Response Rates of Post Month 6: Day 21-35 PRNT80 Titers |
2; 16; 9; 11; 2; 1 | — |
| PRIMARY Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers |
34; 23; 11; 3; 6; 3 | — |
| PRIMARY Response Rates of Annual (11-13 Months) PRNT80 Titers |
11; 3; 12; 6; 5; 2 | — |
| SECONDARY Number of Subject Experiencing Local and Systemic Adverse Events |
19; 47; 10; 29; 18; 30 | — |
Summary
This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.
Eligibility Criteria
Inclusion Criteria
- At least 18 years old.
- EEE PRNT80 ≤ 1:20.
- EEE PRNT80 ≤ 1: 40 for booster series
- (females) Negative pregnancy test on the same day before vaccination.
- Not planning pregnancy for 3 months.
- At risk for exposure to virulent EEE virus (with up-to-date risk assessment).
- Up-to-date (within 1 year) physical examination/tests.
- Sign and date the approved informed consent.
- Willing to return for all follow-up visits.
- Agree to report adverse events (AE) up to 28 days after each vaccination.
Exclusion Criteria
- Over 65 years of age (for Primary Immunization).
- Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2X normal) liver function tests.
- History of immunodeficiency or current treatment with immunosuppressive medication.
- (females) Currently breastfeeding.
- Confirmed human immunodeficiency virus (HIV) titer.
- Any known allergies to components of the vaccine.
- A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety (i.e.-vaccination or exposure to another Alphavirus).
- Administration of any IND product or live vaccine within 28 days of EEE.
- Any unresolved AEs resulting from a previous immunization.
Data sourced from ClinicalTrials.gov (NCT00584805). 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.