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Bull World Health Organ. 1998; 76(1): 63–71.
PMCID: PMC2305629

A single dose of live oral cholera vaccine CVD 103-HgR is safe and immunogenic in HIV-infected and HIV-noninfected adults in Mali.

Abstract

Despite considerable experience with single-dose, live, oral cholera vaccine CVD 103-HgR in Asia, Europe, and the Americas, the vaccine had not been evaluated in sub-Saharan Africa or on individuals infected with human immunodeficiency virus (HIV). We therefore conducted a randomized, 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 recipients. 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-seropositives, and in 40% of HIV-seropositives with CD4+ counts below 500 per microliter. Following immunization, the peak vibriocidal GMT in HIV-seronegatives was 1:584 versus 1:124 in HIV-seropositives (P = 0.0006); in HIV-seropositives with CD4+ counts < 500 per microliter, the peak vibriocidal GMT was 1:40 (P = 0.03 versus other HIV-seropositives). CVD 103-HgR was safe in HIV-infected Malian adults, although serological responses were significantly attenuated among HIV-seropositives (particularly in those with CD4+ counts < 500 per microliter) relative to HIV-seronegatives. These results encourage further evaluations of this single-dose, oral cholera vaccine in high-risk populations such as refugees in sub-Saharan Africa.

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  • Glass RI, Claeson M, Blake PA, Waldman RJ, Pierce NF. Cholera in Africa: lessons on transmission and control for Latin America. Lancet. 1991 Sep 28;338(8770):791–795. [PubMed]
  • Eko FO, Udo SM, Antia-Obong OE. Epidemiology and spectrum of vibrio diarrheas in the lower cross river basin of Nigeria. Cent Eur J Public Health. 1994 Jun;2(1):37–41. [PubMed]
  • Tauxe RV, Holmberg SD, Dodin A, Wells JV, Blake PA. Epidemic cholera in Mali: high mortality and multiple routes of transmission in a famine area. Epidemiol Infect. 1988 Apr;100(2):279–289. [PMC free article] [PubMed]
  • St Louis ME, Porter JD, Helal A, Drame K, Hargrett-Bean N, Wells JG, Tauxe RV. Epidemic cholera in West Africa: the role of food handling and high-risk foods. Am J Epidemiol. 1990 Apr;131(4):719–728. [PubMed]
  • Sack DA. Cholera control. Lancet. 1994 Aug 27;344(8922):616–617. [PubMed]
  • Hatch DL, Waldman RJ, Lungu GW, Piri C. Epidemic cholera during refugee resettlement in Malawi. Int J Epidemiol. 1994 Dec;23(6):1292–1299. [PubMed]
  • Levine MM, Kaper JB, Herrington D, Ketley J, Losonsky G, Tacket CO, Tall B, Cryz S. Safety, immunogenicity, and efficacy of recombinant live oral cholera vaccines, CVD 103 and CVD 103-HgR. Lancet. 1988 Aug 27;2(8609):467–470. [PubMed]
  • Tacket CO, Losonsky G, Nataro JP, Cryz SJ, Edelman R, Kaper JB, Levine MM. Onset and duration of protective immunity in challenged volunteers after vaccination with live oral cholera vaccine CVD 103-HgR. J Infect Dis. 1992 Oct;166(4):837–841. [PubMed]
  • Kotloff KL, Wasserman SS, O'Donnell S, Losonsky GA, Cryz SJ, Levine MM. Safety and immunogenicity in North Americans of a single dose of live oral cholera vaccine CVD 103-HgR: results of a randomized, placebo-controlled, double-blind crossover trial. Infect Immun. 1992 Oct;60(10):4430–4432. [PMC free article] [PubMed]
  • Suharyono, Simanjuntak C, Witham N, Punjabi N, Heppner DG, Losonsky G, Totosudirjo H, Rifai AR, Clemens J, Lim YL, et al. Safety and immunogenicity of single-dose live oral cholera vaccine CVD 103-HgR in 5-9-year-old Indonesian children. Lancet. 1992 Sep 19;340(8821):689–694. [PubMed]
  • Simanjuntak CH, O'Hanley P, Punjabi NH, Noriega F, Pazzaglia G, Dykstra P, Kay B, Suharyono, Budiarso A, Rifai AR, et al. Safety, immunogenicity, and transmissibility of single-dose live oral cholera vaccine strain CVD 103-HgR in 24- to 59-month-old Indonesian children. J Infect Dis. 1993 Nov;168(5):1169–1176. [PubMed]
  • Su-Arehawaratana P, Singharaj P, Taylor DN, Hoge C, Trofa A, Kuvanont K, Migasena S, Pitisuttitham P, Lim YL, Losonsky G, et al. Safety and immunogenicity of different immunization regimens of CVD 103-HgR live oral cholera vaccine in soldiers and civilians in Thailand. J Infect Dis. 1992 Jun;165(6):1042–1048. [PubMed]
  • Gotuzzo E, Butron B, Seas C, Penny M, Ruiz R, Losonsky G, Lanata CF, Wasserman SS, Salazar E, Kaper JB, et al. Safety, immunogenicity, and excretion pattern of single-dose live oral cholera vaccine CVD 103-HgR in Peruvian adults of high and low socioeconomic levels. Infect Immun. 1993 Sep;61(9):3994–3997. [PMC free article] [PubMed]
  • Lagos R, Avendaño A, Prado V, Horwitz I, Wasserman S, Losonsky G, Cryz S, Jr, Kaper JB, Levine MM. Attenuated live cholera vaccine strain CVD 103-HgR elicits significantly higher serum vibriocidal antibody titers in persons of blood group O. Infect Immun. 1995 Feb;63(2):707–709. [PMC free article] [PubMed]
  • Levine MM, Kaper JB. Live oral vaccines against cholera: an update. Vaccine. 1993;11(2):207–212. [PubMed]
  • Rey JL, Milleliri JM, Soares JL, Boutin JP, Desfontaine M, Merouze F, Van de Perre P. HIV seropositivity and cholera in refugee children from Rwanda. AIDS. 1995 Oct;9(10):1203–1204. [PubMed]
  • Bourée P, Lamour P, Bisaro F, Didier E. Etude d'une population d'origine tropicale, VIH positive, dans un centre de réfugiés en France. Bull Soc Pathol Exot. 1995;88(1):24–28. [PubMed]
  • Cossa HA, Gloyd S, Vaz RG, Folgosa E, Simbine E, Diniz M, Kreiss JK. Syphilis and HIV infection among displaced pregnant women in rural Mozambique. Int J STD AIDS. 1994 Mar-Apr;5(2):117–123. [PubMed]
  • Van Rensburg EJ, Lemmer HR, Joubert JJ. Prevalence of viral infections in Mozambican refugees in Swaziland. East Afr Med J. 1995 Sep;72(9):588–590. [PubMed]
  • Wasserman SS, Losonsky GA, Noriega F, Tacket CO, Castañeda E, Levine MM. Kinetics of the vibriocidal antibody response to live oral cholera vaccines. Vaccine. 1994 Aug;12(11):1000–1003. [PubMed]
  • Benenson AS, Saad A, Mosley WH. Serological studies in cholera. 2. The vibriocidal antibody response of cholera patients determined by a microtechnique. Bull World Health Organ. 1968;38(2):277–285. [PMC free article] [PubMed]
  • Clements ML, Levine MM, Young CR, Black RE, Lim YL, Robins-Browne RM, Craig JP. Magnitude, kinetics, and duration of vibriocidal antibody responses in North Americans after ingestion of Vibrio cholerae. J Infect Dis. 1982 Apr;145(4):465–473. [PubMed]
  • Mosley WH, Ahmad S, Benenson AS, Ahmed A. The relationship of vibriocidal antibody titre to susceptibility to cholera in family contacts of cholera patients. Bull World Health Organ. 1968;38(5):777–785. [PMC free article] [PubMed]
  • Glass RI, Svennerholm AM, Khan MR, Huda S, Huq MI, Holmgren J. Seroepidemiological studies of El Tor cholera in Bangladesh: association of serum antibody levels with protection. J Infect Dis. 1985 Feb;151(2):236–242. [PubMed]
  • Clemens JD, van Loon F, Sack DA, Chakraborty J, Rao MR, Ahmed F, Harris JR, Khan MR, Yunus M, Huda S, et al. Field trial of oral cholera vaccines in Bangladesh: serum vibriocidal and antitoxic antibodies as markers of the risk of cholera. J Infect Dis. 1991 Jun;163(6):1235–1242. [PubMed]
  • Levine MM, Young CR, Black RE, Takeda Y, Finkelstein RA. Enzyme-linked immunosorbent assay to measure antibodies to purified heat-labile enterotoxins from human and porcine strains of Escherichia coli and to cholera toxin: application in serodiagnosis and seroepidemiology. J Clin Microbiol. 1985 Feb;21(2):174–179. [PMC free article] [PubMed]
  • Levine MM, Kaper JB, Herrington D, Losonsky G, Morris JG, Clements ML, Black RE, Tall B, Hall R. Volunteer studies of deletion mutants of Vibrio cholerae O1 prepared by recombinant techniques. Infect Immun. 1988 Jan;56(1):161–167. [PMC free article] [PubMed]
  • Mahalanabis D, Choudhuri AB, Bagchi NG, Bhattacharya AK, Simpson TW. Oral fluid therapy of cholera among Bangladesh refugees. Johns Hopkins Med J. 1973 Apr;132(4):197–205. [PubMed]
  • Siddique AK. Failure of treatment centres to prevent cholera deaths in Goma. Lancet. 1995 Aug 5;346(8971):379–379. [PubMed]
  • Clemens JD, Sack DA, Harris JR, Van Loon F, Chakraborty J, Ahmed F, Rao MR, Khan MR, Yunus M, Huda N, et al. Field trial of oral cholera vaccines in Bangladesh: results from three-year follow-up. Lancet. 1990 Feb 3;335(8684):270–273. [PubMed]
  • Sanchez JL, Vasquez B, Begue RE, Meza R, Castellares G, Cabezas C, Watts DM, Svennerholm AM, Sadoff JC, Taylor DN. Protective efficacy of oral whole-cell/recombinant-B-subunit cholera vaccine in Peruvian military recruits. Lancet. 1994 Nov 5;344(8932):1273–1276. [PubMed]
  • Clemens JD, Sack DA, Harris JR, Chakraborty J, Khan MR, Stanton BF, Kay BA, Khan MU, Yunus M, Atkinson W, et al. Field trial of oral cholera vaccines in Bangladesh. Lancet. 1986 Jul 19;2(8499):124–127. [PubMed]
  • Lewis DJ, Gilks CF, Ojoo S, Castello-Branco LR, Dougan G, Evans MR, McDermott S, Griffin GE. Immune response following oral administration of cholera toxin B subunit to HIV-1-infected UK and Kenyan subjects. AIDS. 1994 Jun;8(6):779–785. [PubMed]
  • Huang KL, Ruben FL, Rinaldo CR, Jr, Kingsley L, Lyter DW, Ho M. Antibody responses after influenza and pneumococcal immunization in HIV-infected homosexual men. JAMA. 1987 Apr 17;257(15):2047–2050. [PubMed]
  • Carson PJ, Schut RL, Simpson ML, O'Brien J, Janoff EN. Antibody class and subclass responses to pneumococcal polysaccharides following immunization of human immunodeficiency virus-infected patients. J Infect Dis. 1995 Aug;172(2):340–345. [PubMed]
  • Birx DL, Rhoads JL, Wright JC, Burke DS, Redfield RR. Immunologic parameters in early-stage HIV-seropositive subjects associated with vaccine responsiveness. J Acquir Immune Defic Syndr. 1991;4(2):188–196. [PubMed]
  • Kroon FP, van Dissel JT, de Jong JC, van Furth R. Antibody response to influenza, tetanus and pneumococcal vaccines in HIV-seropositive individuals in relation to the number of CD4+ lymphocytes. AIDS. 1994 Apr;8(4):469–476. [PubMed]
  • Janoff EN, Douglas JM, Jr, Gabriel M, Blaser MJ, Davidson AJ, Cohn DL, Judson FN. Class-specific antibody response to pneumococcal capsular polysaccharides in men infected with human immunodeficiency virus type 1. J Infect Dis. 1988 Nov;158(5):983–990. [PubMed]
  • Collier AC, Corey L, Murphy VL, Handsfield HH. Antibody to human immunodeficiency virus (HIV) and suboptimal response to hepatitis B vaccination. Ann Intern Med. 1988 Jul 15;109(2):101–105. [PubMed]
  • Stanley SK, Ostrowski MA, Justement JS, Gantt K, Hedayati S, Mannix M, Roche K, Schwartzentruber DJ, Fox CH, Fauci AS. Effect of immunization with a common recall antigen on viral expression in patients infected with human immunodeficiency virus type 1. N Engl J Med. 1996 May 9;334(19):1222–1230. [PubMed]
  • Staprans SI, Hamilton BL, Follansbee SE, Elbeik T, Barbosa P, Grant RM, Feinberg MB. Activation of virus replication after vaccination of HIV-1-infected individuals. J Exp Med. 1995 Dec 1;182(6):1727–1737. [PMC free article] [PubMed]
  • O'Brien WA, Grovit-Ferbas K, Namazi A, Ovcak-Derzic S, Wang HJ, Park J, Yeramian C, Mao SH, Zack JA. Human immunodeficiency virus-type 1 replication can be increased in peripheral blood of seropositive patients after influenza vaccination. Blood. 1995 Aug 1;86(3):1082–1089. [PubMed]
  • Glesby MJ, Hoover DR, Farzadegan H, Margolick JB, Saah AJ. The effect of influenza vaccination on human immunodeficiency virus type 1 load: a randomized, double-blind, placebo-controlled study. J Infect Dis. 1996 Dec;174(6):1332–1336. [PubMed]

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