Vaccine
Volume 33, Issue 38, Pages 4737-5026 (11 September 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/38

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Peru-15 (Choleragarde®), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand
Original Research Article
Pages 4820-4826
W. Ratanasuwan, Y.H. Kim, B.K. Sah, S. Suwanagool, D.R. Kim, A. Anekthananon, A.L. Lopez, W. Techasathit, S.L. Grahek, J.D. Clemens, T.F. Wierzba
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.
Conclusion
Peru-15 was shown to be safe and immunogenic in HIV-seropositive Thai adults.