Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
This study is currently recruiting participants.
Verified January 2013 by U.S. Army Medical Research and Materiel Command
Sponsor:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00584805
First received: December 19, 2007
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine
| Condition | Intervention | Phase |
|---|---|---|
|
Eastern Equine Encephalitis |
Biological: Inactivated, Dried, TSI-GSD 104, EEE |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by U.S. Army Medical Research and Materiel Command:
Primary Outcome Measures:
- Safety: The frequency of adverse events in this EEE vaccine study will be evaluated for all intent-to-treat subjects; Immunogenicity: Measurement is the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs recorded through day 28 after each dose; SAEs recorded through duration of study; Immunogenicity: PRNT80 will be assessed after primary series and booster dose; Any EEE illness in a vaccinated subject will be recorded for duration of study. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vaccination |
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.
Other Name: EEE A-14568
|
Detailed Description:
Study Objectives:
Primary:
- 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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- At least 18 years old.
- EEE PRNT80 ≤ 1:20.
- (females) Negative pregnancy test on the same day before vaccination.
- Not planning pregnancy for 3 months.
- Actively enrolled in the SIP.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584805
Contacts
| Contact: Robert Rivard, MD | 301-619-8244 | robert.rivard@amedd.army.mil |
Locations
| United States, Maryland | |
| U.S. Army Medical Research Institute of Infectious Diseases | Recruiting |
| Fort Detrick, Maryland, United States, 21702 | |
| Contact: Robert Rivard, MD 301-619-8244 robert.rivard@amedd.army.mil | |
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
| Principal Investigator: | Robert Rivard, MD | USAMRIID Medical Division |
More Information
No publications provided
| Responsible Party: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT00584805 History of Changes |
| Other Study ID Numbers: | A-14568, FY06-31 |
| Study First Received: | December 19, 2007 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by U.S. Army Medical Research and Materiel Command:
|
EEE |
Additional relevant MeSH terms:
|
Encephalitis Encephalomyelitis, Equine Encephalomyelitis, Eastern Equine Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Infections Arbovirus Infections Encephalitis, Viral Alphavirus Infections Togaviridae Infections RNA Virus Infections Encephalomyelitis |
ClinicalTrials.gov processed this record on May 21, 2013