Eastern Equine Encephalitis Clinical Trial
— EEEOfficial 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
Verified date | October 2018 |
Source | U.S. Army Medical Research and Development Command |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.
Status | Completed |
Enrollment | 138 |
Est. completion date | June 2017 |
Est. primary completion date | June 27, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | U.S. Army Medical Research Institute of Infectious Diseases | Fort Deterick | Maryland |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Development Command |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
5 years | |
Primary | 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. | Post dose 2, days 21-35 | |
Primary | 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. | Pre-month 6 | |
Primary | Response Rates of Post Month 6: Day 21-35 PRNT80 Titers | Subject response rates for PRNT80 titers for post month 6, 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. | Post month 6, days 21-35 | |
Primary | Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers | Subject response rates for PRNT80 titers for post booster 1, 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. | Post booster 1, days 21-35 | |
Primary | Response Rates of Annual (11-13 Months) PRNT80 Titers | Subject annual response rates for PRNT80 titers for months 11-13. 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. | Months 11-13 | |
Secondary | Number of Subject Experiencing Local and Systemic Adverse Events | Number of subjects of who experienced and didn't experience local and systemic adverse events after vaccination and booster. | vaccination/booster days 0-28 for up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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