Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine

U.S. Army Medical Research and Development Command138 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

138

Conditions

Eastern Equine Encephalitis

Interventions

Inactivated, Dried, TSI-GSD 104, EEEBIOLOGICAL

Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, United States

Outcomes

Primary Outcomes

Subject Response Rates for PRNT80 Titers

Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution).

Time frame: 5 years

Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers

Subject response rates for PRNT80 titers for post dose 2, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.

Time frame: Post dose 2, days 21-35

Response Rates of Pre-Month 6 PRNT80 Titers

Subject response rates for PRNT80 titers of pre-month 6. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.

Time frame: Pre-month 6

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.