TY - JOUR
T1 - The Western Equine Encephalitis Lyophilized, Inactivated Vaccine
T2 - An Update on Safety and Immunogenicity
AU - Keshtkar-Jahromi, Maryam
AU - Reisler, Ronald B.
AU - Haller, Jeannine M.
AU - Clizbe, Denise P.
AU - Rivard, Robert G.
AU - Cardile, Anthony P.
AU - Pierson, Benjamin C.
AU - Norris, Sarah
AU - Saunders, David
AU - Pittman, Phillip R.
N1 - Funding Information:
The authors thank all personnel, staff, and subjects participating in the Special Immunizations Program at the U.S. Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD, between 1987 and 2011 and associated and partnering organizations.
Publisher Copyright:
© Copyright © 2020 Keshtkar-Jahromi, Reisler, Haller, Clizbe, Rivard, Cardile, Pierson, Norris, Saunders and Pittman.
PY - 2020/11/9
Y1 - 2020/11/9
N2 - Background: Western Equine Encephalitis (WEE) is a naturally acquired infection and potentially devastating bioweapon, with no specific human countermeasures. An experimental inactivated Western Equine Encephalitis Vaccine (WEEV; WEE TSI-GSD 210) has been used under an IND (investigational New Drug) protocol at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) since 1976. Methods: Over 24 years from 1987 to 2011, 876 subjects received 3 primary vaccine doses under 3 studies with 1,537 booster doses administered (FY87-8, phase 2, laboratory workers, vaccine lots 1-81-1, 1-81-2, and 2-1-91; FY99-12, phase 2 laboratory workers, lot 2-1-91; and FY09-02, phase 1 healthy volunteer, lot 3-1-92). Post-vaccination safety and immunogenicity [plaque reduction neutralization test 80% (PRNT80) > 1:40] were analyzed. Results: Overall PRNT80 response to the primary series in FY87-8 was 42% (326/770) but dropped to 16% (14/87) in FY99-12, prompting study FY09-02, which achieved 89% (17/19). The first booster response rate was 68% (814/1194) in FY87-8, 53% (171/324) in FY99-12, and 100% (10/10) in FY09-02. The majority of definitely related adverse reactions (AEs) were mild and local with no definitely related serious AEs. No laboratory acquired WEE infection was documented during this period despite 4 reported exposures in vaccinated subjects. Conclusion: The TSI-GSD 210 WEE vaccine was immunogenic, safe and well tolerated. Use of this vaccine could be considered in an emergency setting. Despite decades of safe and effective use under IND, full licensure is not planned due to manufacturing constraints, and a strategic decision to develop alternatives. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT01159561.
AB - Background: Western Equine Encephalitis (WEE) is a naturally acquired infection and potentially devastating bioweapon, with no specific human countermeasures. An experimental inactivated Western Equine Encephalitis Vaccine (WEEV; WEE TSI-GSD 210) has been used under an IND (investigational New Drug) protocol at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) since 1976. Methods: Over 24 years from 1987 to 2011, 876 subjects received 3 primary vaccine doses under 3 studies with 1,537 booster doses administered (FY87-8, phase 2, laboratory workers, vaccine lots 1-81-1, 1-81-2, and 2-1-91; FY99-12, phase 2 laboratory workers, lot 2-1-91; and FY09-02, phase 1 healthy volunteer, lot 3-1-92). Post-vaccination safety and immunogenicity [plaque reduction neutralization test 80% (PRNT80) > 1:40] were analyzed. Results: Overall PRNT80 response to the primary series in FY87-8 was 42% (326/770) but dropped to 16% (14/87) in FY99-12, prompting study FY09-02, which achieved 89% (17/19). The first booster response rate was 68% (814/1194) in FY87-8, 53% (171/324) in FY99-12, and 100% (10/10) in FY09-02. The majority of definitely related adverse reactions (AEs) were mild and local with no definitely related serious AEs. No laboratory acquired WEE infection was documented during this period despite 4 reported exposures in vaccinated subjects. Conclusion: The TSI-GSD 210 WEE vaccine was immunogenic, safe and well tolerated. Use of this vaccine could be considered in an emergency setting. Despite decades of safe and effective use under IND, full licensure is not planned due to manufacturing constraints, and a strategic decision to develop alternatives. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT01159561.
KW - Western Equine Encephalitis
KW - clinical trial
KW - immunogenicity
KW - inactivated
KW - vaccine
UR - http://www.scopus.com/inward/record.url?scp=85096536686&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85096536686&partnerID=8YFLogxK
U2 - 10.3389/fimmu.2020.555464
DO - 10.3389/fimmu.2020.555464
M3 - Article
C2 - 33240257
AN - SCOPUS:85096536686
SN - 1664-3224
VL - 11
JO - Frontiers in immunology
JF - Frontiers in immunology
M1 - 555464
ER -