A randomised, double-blind, controlled trial of a killed L. major vaccine plus BCG against zoonotic cutaneous leishmaniasis in Iran

Momeni, Ali; Jalayer, T; Emamjomeh, Morteza; Khamesipour, Ali; Zicker, Fábio; Ghassemi, R L; Dowlati, Yahya; Sharifi, Iraj; Aminjavaheri, Mali; Shafiei, A; Alimohammadian, Mohammad Hossein; Hashemi-Fesharki, R.; Nasseri, Kiumarss; Godal, Tore; Smith, P. G.; Modabber, Farrokh

doi:10.1016/s0264-410x(98)00220-5

Cited by 130 publications

(86 citation statements)

References 14 publications

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“…In first-generation vaccine trials, persons with negative LST results were recruited and those who became LST positive had a lower incidence of disease but not all were protected. 28 Protection showed a maximum rate of 50%, 29 and those protected may have produced IFN-γ. The QFN test would have been a useful tool to address this issue.…”

Section: Discussionmentioning

confidence: 95%

Assessment of Interferon-γ Levels and Leishmanin Skin Test Results in Persons Recovered for Leishmaniasis

Alimohammadian

Jones²,

Darabi³

et al. 2012

The American Society of Tropical Medicine and Hygiene

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Abstract. Patients who recover from leishmaniasis usually show development of strong immunity and induction of interferon-γ (IFN-γ) and delayed type hypersensitivity. In a randomized trial, we analyzed the IFN-γ response by using a Quantiferon-Leishmania assay against three Leishmania peptide antigens and compared it with results of the leishmanin skin test (LST) in persons residing in areas in Iran to which zoonotic cutaneous leishmaniasis (ZCL, 181 persons), anthroponotic cutaneous leishmaniasis (ACL, 104 persons), and zoonotic visceral leishmaniasis (ZVL, 67 persons) are endemic. The percentage of persons with an IFN-γ-positive response ( 0.2 IU/mL) to three antigens and the mean concentration of IFN-γ induced by the antigens were higher for persons from areas endemic for ZVL than for persons from areas endemic for ZCL and ACL. The percentage of persons with LST-positive results ( 5 mm indurations) was 99%, 94%, and 70% for areas with ZCL, ACL, and ZVL, respectively. Our data indicate that the LST is significantly more sensitive than IFN-γ levels in persons who have been cured of cutaneous leishmaniasis than in persons who have been cured of ZVL.

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Section: Discussionmentioning

confidence: 95%

Assessment of Interferon-γ Levels and Leishmanin Skin Test Results in Persons Recovered for Leishmaniasis

Alimohammadian

Jones²,

Darabi³

et al. 2012

The American Society of Tropical Medicine and Hygiene

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“…In the present studies, the ALM, which has been given with bacillus Calmette-Guérin as adjuvant in phase III clinical trials (21,22), was given with rIL-12, which has been shown to be a powerful adjuvant for killed Leishmania or recombinant protein vaccines in both mouse and monkey models (13,16,19,20). The DNA vaccine used was a mixture of plasmid DNAs encoding the Ags LACK, LmSTI1, and TSA.…”

Section: Discussionmentioning

confidence: 99%

“…The immunization with protein was conducted by the injection of 50 g of heat-killed L. major promastigotes (ALM) 3 with or without 1.5 g of rIL-12 (Genetics Institute, Cambridge, MA). The protein-based vaccine was prepared from whole-cell, heat-killed L. major (ALM) and is identical to that being used with BCG as adjuvant in phase III clinical trials in Iran and Sudan (21,22). Each group was boosted 2 wk later using the same regimen.…”

Section: Immunizationmentioning

confidence: 99%

The Potency and Durability of DNA- and Protein-Based Vaccines Against Leishmania major Evaluated Using Low-Dose, Intradermal Challenge

Méndez

Gurunathan

Kamhawi

et al. 2001

The Journal of Immunology

128

104

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DNA- and protein- based vaccines against cutaneous leishmaniasis due to Leishmania major were evaluated using a challenge model that more closely reproduces the pathology and immunity associated with sand fly-transmitted infection. C57BL/6 mice were vaccinated s.c. with a mixture of plasmid DNAs encoding the Leishmania Ags LACK, LmSTI1, and TSA (AgDNA), or with autoclaved L. major promastigotes (ALM) plus rIL-12, and the mice were challenged by inoculation of 100 metacyclic promastigotes in the ear dermis. When challenged at 2 wk postvaccination, mice receiving AgDNA or ALM/rIL-12 were completely protected against the development of dermal lesions, and both groups had a 100-fold reduction in peak dermal parasite loads compared with controls. When challenged at 12 wk, mice vaccinated with ALM/rIL-12 maintained partial protection against dermal lesions and their parasite loads were no longer significantly reduced, whereas the mice vaccinated with AgDNA remained completely protected and had a 1000-fold reduction in dermal parasite loads. Mice vaccinated with AgDNA also harbored few, if any, parasites in the skin during the chronic phase, and their ability to transmit L. major to vector sand flies was completely abrogated. The durable protection in mice vaccinated with AgDNA was associated with the recruitment of both CD8+ and CD4+ T cells to the site of intradermal challenge and with IFN-γ production by CD8+ T cells in lymph nodes draining the challenge site. These data suggest that under conditions of natural challenge, DNA vaccination has the capacity to confer complete protection against cutaneous leishmaniasis and to prevent the establishment of infection reservoirs.

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“…Alum has been previously used in leishmania candidate vaccines alone or in combination with other adjuvants (KENNEY et al, 1999;MISRA et al, 2001;TONUI et al, 2004). Montanide ISA 720 (MISA 720) has been recommended by the manufacturer for clinical trials in humans (GOMEZ et al, 1999 as an adjuvant is regarded as an acceptable practice in humans, and at present this adjuvant is routinely used in vaccination and immunotherapy trials against leishmaniasis (CONVIT et al, 1989;BAHAR et al, 1996;SHARIFI et al, 1998;MOMENI et al, 1999;KHALIL et al, 2000). Despite the availability of numerous studies on development and evaluation of candidate vaccines against leishmaniasis, very limited data is available on the use of formalin-killed promastigotes in these studies.…”

Section: Introductionmentioning

confidence: 99%

Subcutaneous immunization against Leishmania major - infection in mice: efficacy of formalin-killed promastigotes combined with adjuvants

Mutiso

Macharia

Mutisya

et al. 2010

Rev. Inst. Med. trop. S. Paulo

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SUMMARYFormalin-killed promastigotes (FKP) of Leishmania major, in combination with Montanide ISA 720 (MISA), BCG or alum were used in vaccination of an inbred murine model against cutaneous leishmaniasis (CL). Significant and specific increases in anti-FKP IgG responses were detected for both alum-FKP and BCG-FKP compared to MISA-FKP (p < 0.001). Significant increases in splenic lymphocyte recall proliferation was obtained in the MISA-FKP vaccinated mice compared to alum-FKP or BCG-FKP vaccinated groups (p < 0.01). The highest interferon-γ responses were observed in the BCG-FKP group followed by the MISA-FKP while the alum-FKP gave the least responses. Significantly reduced lesion sizes were obtained in the MISA-FKP group compared to the BCG/ alum adjuvants-FKP vaccinated groups. Although the BCG-FKP group showed the highest IFN-γ responses, it failed to control cutaneous lesions. Significant reductions in parasite numbers were observed in the MISA-FKP and BCG-FKP vaccinated groups (p < 0.001). There was a good correlation between parasite burden and IFN-γ level indicating IFN-γ response as a sensitive parameter of the immune status. In conclusion, MISA-FKP is the most efficacious vaccine formulation against murine cutaneous leishmaniasis.

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A randomised, double-blind, controlled trial of a killed L. major vaccine plus BCG against zoonotic cutaneous leishmaniasis in Iran

Cited by 130 publications

References 14 publications

Assessment of Interferon-γ Levels and Leishmanin Skin Test Results in Persons Recovered for Leishmaniasis

Assessment of Interferon-γ Levels and Leishmanin Skin Test Results in Persons Recovered for Leishmaniasis

The Potency and Durability of DNA- and Protein-Based Vaccines Against Leishmania major Evaluated Using Low-Dose, Intradermal Challenge

Subcutaneous immunization against Leishmania major - infection in mice: efficacy of formalin-killed promastigotes combined with adjuvants

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