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

NCT ID: NCT00584805

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-03
• Study Completion Date: 2017-06-30

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.

Conditions

Eastern Equine Encephalitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaccination

Inactivated, Dried, TSI-GSD 104, EEE

Group Type: EXPERIMENTAL

Inactivated, Dried, TSI-GSD 104, EEE

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

EEE A-14568

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Rivard, MD

Role: PRINCIPAL_INVESTIGATOR

USAMRIID Medical Division

Locations

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33899755 (View on PubMed)

Other Identifiers

FY06-31

Identifier Type: OTHER

Identifier Source: secondary_id

S-09-12

Identifier Type: OTHER

Identifier Source: secondary_id

A-14568

Identifier Type: -

Identifier Source: org_study_id