W. RatanasuwanY. H. KimB. K. SahS. SuwanagoolD. R. KimA. AnekthananonA. L. LopezW. TechasathitS. L. GrahekJ. D. ClemensT. F. WierzbaMahidol UniversityInternational Vaccine Institute, SeoulUniversity of the Philippines ManilaGeorge Washington University School of Medicine and Health SciencesSabin Vaccine InstituteInternational Centre for Diarrhoeal Disease Research Bangladesh2018-11-232018-11-232015-01-01Vaccine. Vol.33, No.38 (2015), 4820-4826187325180264410X2-s2.0-84940721046https://repository.li.mahidol.ac.th/handle/20.500.14594/35644© 2015 Elsevier Ltd. Background: Many areas with endemic and epidemic cholera report significant levels of HIV transmission. According to the World Health Organization (WHO), over 95% of reported cholera cases occur in Africa, which also accounts for nearly 70% of people living with HIV/AIDS globally. Peru-15, a promising single dose live attenuated oral cholera vaccine (LA-OCV), was previously found to be safe and immunogenic in cholera endemic areas. However, no data on the vaccine's safety among HIV-seropositive adults had been collected. Methods: This study was a double-blinded, individually randomized, placebo-controlled trial enrolling HIV-seropositive adults, 18-45 years of age, conducted in Bangkok, Thailand, to assess the safety of Peru-15 in a HIV-seropositive cohort. Results: 32 HIV infected subjects were randomized to receive either a single oral dose of the Peru-15 vaccine with a buffer or a placebo (buffer only). No serious adverse events were reported during the follow-up period in either group. The geometric mean fold (GMF) rise in V. cholerae O1 El Tor specific antibody titers between baseline and 7 days after dosing was 32.0 (. p<. 0.001) in the vaccine group compared to 1.6 (. p<. 0.14) in the placebo group. Among the 16 vaccinees,14 vaccinees (87.5%) had seroconversion compared to 1 of 16 placebo recipients (6.3%). V. cholerae was isolated from the stool of one vaccinee, and found to be genetically identical to the Peru-15 vaccine strain. There were no significant changes in HIV viral load or CD4 T-cell counts between vaccine and placebo groups. Conclusion: Peru-15 was shown to be safe and immunogenic in HIV-seropositive Thai adults.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyImmunology and MicrobiologyArticleSCOPUS10.1016/j.vaccine.2015.07.073