TY - JOUR
T1 - A non-inferiority trial comparing two killed, whole cell, oral cholera vaccines (Cholvax vs. Shanchol) in Dhaka, Bangladesh
AU - Chowdhury, Fahima
AU - Akter, Afroza
AU - Bhuiyan, Taufiqur Rahman
AU - Tauheed, Imam
AU - Teshome, Samuel
AU - Sil, Arijit
AU - Park, Ju Yeon
AU - Chon, Yun
AU - Ferdous, Jannatul
AU - Basher, Salima Raiyan
AU - Ahmed, Faez
AU - Karim, Mahbubul
AU - Ahasan, Mohammad Mainul
AU - Mia, Masudur Rahman
AU - Masud, Mir Mohammad Ibna
AU - Khan, Abdul Wahab
AU - Billah, Masum
AU - Nahar, Zebun
AU - Khan, Imran
AU - Ross, Allen G.
AU - Kim, Deok Ryun
AU - Ashik, Md Muktadir Rahman
AU - Digilio, Laura
AU - Lynch, Julia
AU - Excler, Jean Louis
AU - Clemens, John D.
AU - Qadri, Firdausi
N1 - Funding Information:
The Cholvax study was supported by a grant from the Bill & Melinda Gates Foundation to the International Vaccine Institute (IVI). The study is also supported by core grants from the Governments of Bangladesh, Canada, Sweden, and the UK to the International Centre for Diarrhoeal Disease Research (icddr,b) and Emerging Global Leader Award; K43 TW010362, R01 AI130378. Thanks to Dr. Nigel A McMillan for his scientific inputs and review of the manuscript. We are grateful to the members of the data and safety monitoring board, the staff members of icddr,b and IVI for their work in the field and laboratory and for data management and the residence of Mirpur for their participation in the trials.
Publisher Copyright:
© 2021 The Author(s)
PY - 2022/1/28
Y1 - 2022/1/28
N2 - Bangladesh remains cholera
endemic with biannual seasonal peaks causing epidemics. At least
300,000 severe cases and over 4,500 deaths occur each year. The
available oral cholera vaccines have not yet
been adopted for cholera control in Bangladesh due to insufficient
number of doses available for endemic control. With a public private partnership, icddr,b initiated a collaboration between vaccine manufacturers in Bangladesh and abroad. A locally manufactured Oral Cholera Vaccine (OCV) named Cholvax became available for testing in Bangladesh. We evaluated the safety and immunogenicity
of this locally produced Cholvax (Incepta Vaccine Ltd) inexpensive OCV
comparatively to Shanchol (Shantha Biotechnics-Sanofi Pasteur) which is
licensed in several countries. We conducted a randomized non-inferiority
clinical trial of bivalent, killed oral whole-cell cholera vaccine
Cholvax vs. Shanchol in the cholera-endemic area of Mirpur, Dhaka, among
three different age cohorts (1–5, 6–17 and 18–45 years) between April
2016 and April 2017. Two vaccine doses were given at 14 days apart to
2,052 healthy participants. No vaccine-related serious adverse events
were reported. There were no significant differences in the frequency of
solicited (7.31% vs. 6.73%) and unsolicited (1.46% vs. 1.07%) adverse
events reported between the Cholvax and Shanchol groups. Vibriocidal antibody responses among the overall population for O1 Ogawa (81% vs. 77%) and O1 Inaba (83% vs. 84%) serotypes
showed that Cholvax was non-inferior to Shanchol, with the
non-inferiority margin of −10%. For O1 Inaba, GMT was 462.60 (Test
group), 450.84 (Comparator group) with GMR 1.02(95% CI: 0.92, 1.13). For
O1 Ogawa, GMT was 419.64 (Test group), 387.22 (Comparator group) with
GMR 1.12 (95% CI: 1.02, 1.23). Cholvax was safe and non-inferior to
Shanchol in terms of immunogenicity in the different age groups. These
results support public use of Cholvax to contribute for reduction of the
cholera burden in Bangladesh. ClinicalTrials.gov number: NCT027425581.
AB - Bangladesh remains cholera
endemic with biannual seasonal peaks causing epidemics. At least
300,000 severe cases and over 4,500 deaths occur each year. The
available oral cholera vaccines have not yet
been adopted for cholera control in Bangladesh due to insufficient
number of doses available for endemic control. With a public private partnership, icddr,b initiated a collaboration between vaccine manufacturers in Bangladesh and abroad. A locally manufactured Oral Cholera Vaccine (OCV) named Cholvax became available for testing in Bangladesh. We evaluated the safety and immunogenicity
of this locally produced Cholvax (Incepta Vaccine Ltd) inexpensive OCV
comparatively to Shanchol (Shantha Biotechnics-Sanofi Pasteur) which is
licensed in several countries. We conducted a randomized non-inferiority
clinical trial of bivalent, killed oral whole-cell cholera vaccine
Cholvax vs. Shanchol in the cholera-endemic area of Mirpur, Dhaka, among
three different age cohorts (1–5, 6–17 and 18–45 years) between April
2016 and April 2017. Two vaccine doses were given at 14 days apart to
2,052 healthy participants. No vaccine-related serious adverse events
were reported. There were no significant differences in the frequency of
solicited (7.31% vs. 6.73%) and unsolicited (1.46% vs. 1.07%) adverse
events reported between the Cholvax and Shanchol groups. Vibriocidal antibody responses among the overall population for O1 Ogawa (81% vs. 77%) and O1 Inaba (83% vs. 84%) serotypes
showed that Cholvax was non-inferior to Shanchol, with the
non-inferiority margin of −10%. For O1 Inaba, GMT was 462.60 (Test
group), 450.84 (Comparator group) with GMR 1.02(95% CI: 0.92, 1.13). For
O1 Ogawa, GMT was 419.64 (Test group), 387.22 (Comparator group) with
GMR 1.12 (95% CI: 1.02, 1.23). Cholvax was safe and non-inferior to
Shanchol in terms of immunogenicity in the different age groups. These
results support public use of Cholvax to contribute for reduction of the
cholera burden in Bangladesh. ClinicalTrials.gov number: NCT027425581.
KW - Cholera
KW - Cholvax
KW - Clinical trial
KW - Non-inferiority
KW - OCV
KW - Oral vaccines
UR - http://www.scopus.com/inward/record.url?scp=85121927094&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85121927094&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2021.12.015
DO - 10.1016/j.vaccine.2021.12.015
M3 - Article
C2 - 34969541
AN - SCOPUS:85121927094
VL - 40
SP - 640
EP - 649
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 4
ER -
