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

Eastern Equine Encephalitis Clinical Trial

— EEE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584805
• Other study ID #: A-14568
• Secondary ID: FY06-31S-09-12
• Status: Completed
• Phase: Phase 2
• Start date: June 3, 2008
• Est. completion date: June 2017

Study information

• Verified date: October 2018
• Source: U.S. Army Medical Research and Development Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Eastern Equine Encephalitis
• Encephalitis
• Encephalomyelitis, Equine

Intervention

Biological:
• Inactivated, Dried, TSI-GSD 104, EEE
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.

Locations

Country	Name	City	State
United States	U.S. Army Medical Research Institute of Infectious Diseases	Fort Deterick	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

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