A SINGLE-DOSE OF LIVE ORAL CHOLERA VACCINE CVD 103-HGR IS SAFE AND IMMUNOGENIC IN HIV-INFECTED AND HIV-NONINFECTED ADULTS IN MALI

Despite considerable experience with single-dose, live, oral cholera v accine CVD 103-HgR in Asia, Europe, and the Americas, the vaccine had not been evaluated in sub-Saharan Africa or on individuals infected wi th human immunodeficiency virus (HIV). We therefore conducted a random ized, placebo-controlled double-blind, cross-over clinical trial in 38 HIV-seropositive (without clinical acquired immunodeficiency syndrome (AIDS)) and 387 HIV-seronegative adults in Mali to assess its safety and immunogenicity. Adverse reactions (fever, diarrhoea and vomiting) were observed with similar frequency among vaccine and placebo recipie nts. The Vaccine strain was not isolated from the coprocultures of any subject. The baseline geometric mean titre (GMT) of serum vibriocidal antibody was significantly lower in HIV-seropositives (1:23) than in HIV-seronegatives (1:65) (P = 0.002). Significant rises in vibriocidal antibody were observed in 71% of HIV-seronegatives and 58% of HIV-ser opositives, and in 40% of HIV-seropositives with CD4(+) counts below 5 00 per mu l. Following immunization, the peak vibriocidal GMT in HIV-s eronegatives was 1:584 versus 1: 124 in HIV-seropositives (P = 0.0006) ; in HIV-seropositives with CD4(+) counts <500 per mu l the peak vibri ocidal GMT was 1:40 (P = 0.03 versus other HIV-seropositives). CVD 103 -HgR was safe in HIV-infected Malian adults, although serological resp onses were significantly attenuated among HIV-seropositives (particula rly in those with CD4(+) counts < 500 per mu l) relative to HIV-serone gatives. These results encourage further evaluations of this single-do se, oral cholera vaccine in highrisk populations such as refugees in s ub-Saharan Africa.