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

NCT00584805 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: A-14568FY06-31S-09-12
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eastern Equine Encephalitis

Keywords

EEE

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Number of Subject Experiencing Local and Systemic Adverse Events

  vaccination/booster days 0-28 for up to 5 years

Study Arms (1)

Vaccination

EXPERIMENTAL

Inactivated, Dried, TSI-GSD 104, EEE

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

Interventions

Inactivated, Dried, TSI-GSD 104, EEE 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.

Also known as: EEE A-14568

Vaccination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

Location

Related Publications (1)

• 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.

  PMID: 33899755 DERIVED

MeSH Terms

Conditions

Encephalomyelitis, Eastern Equine

Interventions

Desiccation

Condition Hierarchy (Ancestors)

Encephalomyelitis, Equine; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Encephalomyelitis; Infectious Encephalitis; Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Encephalitis, Arbovirus; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Results Point of Contact

• Title: Anthony Cardile, D.O.
• Organization: USAMRIID Medical Division

anthony.cardile.mil@mail.mil

301-619-8833

Study Officials

• Robert Rivard, MD

  USAMRIID Medical Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: January 2, 2008
• Study Start: June 3, 2008
• Primary Completion: June 27, 2016
• Study Completion: June 1, 2017
• Last Updated: September 24, 2019
• Results First Posted: September 24, 2019

Record last verified: 2018-10

Locations

US (1)