title: Peru-15 (Choleragarde(®)), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand.
abstract: 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.
  
  
  CONCLUSIONS
  Peru-15 was shown to be safe and immunogenic in HIV-seropositive Thai adults.
authors.affiliation: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: W
authors.initials: W
authors.lastname: Ratanasuwan
authors.affiliation: International Vaccine Institute, Seoul, Republic of Korea. Electronic address: yhkim@ivi.int.
authors.forename: Y H
authors.initials: YH
authors.lastname: Kim
authors.affiliation: International Vaccine Institute, Seoul, Republic of Korea.
authors.forename: B K
authors.initials: BK
authors.lastname: Sah
authors.affiliation: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: S
authors.initials: S
authors.lastname: Suwanagool
authors.affiliation: International Vaccine Institute, Seoul, Republic of Korea.
authors.forename: D R
authors.initials: DR
authors.lastname: Kim
authors.affiliation: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: A
authors.initials: A
authors.lastname: Anekthananon
authors.affiliation: University of the Philippines Manila - National Institutes of Health, Manila, Philippines.
authors.forename: A L
authors.initials: AL
authors.lastname: Lopez
authors.affiliation: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: W
authors.initials: W
authors.lastname: Techasathit
authors.affiliation: The George Washington University School of Medicine and Health Sciences, Washington, DC, United States; Sabin Vaccine Institute, Washington, DC, United States.
authors.forename: S L
authors.initials: SL
authors.lastname: Grahek
authors.affiliation: International Center for Diarrheal Disease Research, Dhaka, Bangladesh.
authors.forename: J D
authors.initials: JD
authors.lastname: Clemens
authors.affiliation: International Vaccine Institute, Seoul, Republic of Korea.
authors.forename: T F
authors.initials: TF
authors.lastname: Wierzba
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D002771:Cholera / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D013785:Thailand; D016896:Treatment Outcome; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; C497037:Peru 15; D010919:Placebos; D014613:Vaccines, Attenuated
keywords: HIV-seropositive adult; Immunogenicity; Live attenuated cholera vaccine; Oral cholera vaccine; Peru-15; Safety