Clinical trial NCT00584805: Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
Official title: A Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104 in Healthy Adults At Risk for Exposure to Eastern Equine Encephalitis Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eastern Equine Encephalitis
Keywords: EEE
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2008-01-02
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.

Detailed description: This was an open-label, vaccine study of Eastern Equine Encephalitis Vaccine, Inactivated Dried, EEE, TSI-GSD 104 in healthy, adult subjects. No concurrent control group was used. The controls used in this study to assess immunogenicity were historical PRNT80 values obtained in past studies of the EEE vaccine. Rates of adverse events (AEs) were tabulated by relationship to product administration and severity.

The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.

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.

Primary outcomes:
measure: Subject Response Rates for PRNT80 Titers
timeFrame: 5 years
measure: Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
timeFrame: Post dose 2, days 21-35
measure: Response Rates of Pre-Month 6 PRNT80 Titers
timeFrame: Pre-month 6
measure: Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
timeFrame: Post month 6, days 21-35
measure: Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
timeFrame: Post booster 1, days 21-35
measure: Response Rates of Annual (11-13 Months) PRNT80 Titers
timeFrame: Months 11-13
Secondary outcomes:
measure: Number of Subject Experiencing Local and Systemic Adverse Events
timeFrame: vaccination/booster days 0-28 for up to 5 years
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: U.S. Army Medical Research Institute of Infectious Diseases
state: Maryland
Study officials:
affiliation: USAMRIID Medical Division
name: Robert Rivard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schultz JS, Sparks H, Beckham JD. Arboviral central nervous system infections. Curr Opin Infect Dis. 2021 Jun 1;34(3):264-271. doi: 10.1097/QCO.0000000000000729.