Peru-15 (Choleragarde (R)), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand

作者：Ratanasuwan W; Kim Y H^*; Sah B K; Suwanagool S; Kim D R; Anekthananon A; Lopez A L; Techasathit W; Grahek S L; Clemens J D; Wierzba T F

来源：Vaccine, 2015, 33(38): 4820-4826.

DOI：10.1016/j.vaccine.2015.07.073

• Oral cholera vaccine
• Peru-15
• Live attenuated cholera vaccine
• Immunogenicity
• Safety
• HIV-seropositive adult

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.

• 出版日期2015-9-11