A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines.
BACKGROUND
Currently, there are two oral cholera vaccines (OCV) that are prequalified by the World Health Organization. Both (Dukoral and Shanchol) have been proven to be safe, immunogenic, and effective. As the global supply of OCV remains limited, we assessed the safety and immunogenicity of a new low cost, killed, bivalent OCV (Euvichol) in the Philippines.


METHODS
The randomized controlled trial was carried out in healthy Filipino adults and children. Two doses of either the current WHO prequalified OCV (Shanchol) or the same composition OCV being considered for WHO prequalification (Euvichol) were administered to participants.


RESULTS
The pivotal study was conducted in total of 1263 healthy participants (777 adults and 486 children). No serious adverse reactions were elicited in either vaccine groups. Vibriocidal antibody responses to V. cholerae O1 Inaba following administration of two doses of Euvichol were non-inferior to those of Shanchol in adults (82% vs 76%) and children (87% vs 89%). Similar findings were observed for O1 Ogawa in adults (80% vs 74%) and children (91% vs 88%).


CONCLUSIONS
A two dose schedule with Euvichol induces a strong vibriocidal response comparable to those elicited by the currently WHO prequalified OCV, Shanchol. Euvichol will be an oral cholera vaccine suitable for use in lower income countries, where cholera still has a significant economic and public health impact.
EuBiologics Co., Ltd., Seoul, Republic of Korea; Department of Biotechnology, Korea University, Seoul, Republic of Korea.
Yeong Ok
YO
Baik
EuBiologics Co., Ltd., Seoul, Republic of Korea; Department of Biotechnology, Korea University, Seoul, Republic of Korea.
Seuk Keun
SK
Choi
Research Institute for Tropical Medicine, Muntinlupa City, Philippines.
Remigio M
RM
Olveda
De Lasalle University Medical Center, Dasmarinas, Philippines.
Roberto A
RA
Espos
National Children's Hospital, Quezon, Philippines.
Antonio D
AD
Ligsay
Mary Chiles General Hospital, Manila, Philippines.
May B
MB
Montellano
EuBiologics Co., Ltd., Seoul, Republic of Korea.
Jong Sun
JS
Yeam
Clinical Immunology, Laboratory Science Unit, International Vaccine Institute (IVI), Seoul, Republic of Korea.
Jae Seung
JS
Yang
Development and Delivery, International Vaccine Institute (IVI), Seoul, Republic of Korea.
Ju Yeon
JY
Park
Development and Delivery, International Vaccine Institute (IVI), Seoul, Republic of Korea.
Deok Ryun
DR
Kim
Development and Delivery, International Vaccine Institute (IVI), Seoul, Republic of Korea.
Sachin N
SN
Desai
Development and Delivery, International Vaccine Institute (IVI), Seoul, Republic of Korea.
Ajit Pal
AP
Singh
Department of Biotechnology, Korea University, Seoul, Republic of Korea.
Ick Young
IY
Kim
Department of Biotechnology, Korea University, Seoul, Republic of Korea.
Chan Wha
CW
Kim
EuBiologics Co., Ltd., Seoul, Republic of Korea. Electronic address: suenie@eubiologics.com.
Sue-nie
SN
Park
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D001770:Blood Bactericidal Activity; D002648:Child; D002675:Child, Preschool; D002771:Cholera / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D010679:Philippines; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000914:Antibodies, Viral; D022121:Cholera Vaccines; D015164:Vaccines, Inactivated
Adults; Children; Euvichol; Immunogenicity; Oral cholera vaccine; Safety; Shanchol