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Review of Development of Live Vaccines Against Leishmaniasis

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Review of Development of Live Vaccines Against Leishmaniasis Published online: 2021-06-26 THIEME e178 Review Article Review of Development of Live Vaccines against Leishmaniasis Mohammad Hossein Feiz Haddad1,2 Jalal Lomei3 Azar Shokri4 Habib Habibpour1,2 Hossein Rezvan5 Alireza Nourian5 Mohammad Reza Mahmoudi6 1 Cellular and Molecular Research Center, Ahvaz Jundishapur Address for correspondence Habib Habibpour, PhD, Department of University of Medical Sciences, Ahvaz, Iran Parasitology, Faculty of Medicine, Ahvaz Jundishapur University of 2 Department of Parasitology, Faculty of Medicine, Ahvaz Jundishapur Medical Sciences, Ahvaz, Iran (e-mail: [email protected]). University of Medical Sciences, Ahvaz, Iran 3 Division of Integrative Physiology, Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden 4 Vector-borne Disease Research Center, North Khorasan University of Medical Sciences, Bojnurd, Iran 5 Department of Pathobiology, Faculty of Veterinary Science, Bu-Ali Sina University, Hamedan, Iran 6 Cellular and Molecular Research Center, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran J Child Sci 2021;11:e178–e184. Abstract Leishmaniasis is a serious public health problem in both tropical and temperate regions, caused by protozoan parasites of the genus Leishmania. Cutaneous leishmani- asis is the most common form of leishmaniasis worldwide. After recovery from the initial infection in most of the patients, a long-lasting natural immunity will be established. In individuals with HIV infection or in immune deficient patients, the more dangerous forms can occur. Despite many attempts, there is no efficient vaccine for leishmaniasis. The main concern for live-attenuated vaccines is the possibility of returning to the virulent form. Therefore, the safety is an important point in designing a successful vaccine. Nonvirulent parasites as vaccine candidates are achievable through gamma-irradiation, long-term culture, random mutations induced by chemical agents, and temperature-sensitive mutations. The type of change(s) in such parasites is not known well and drawbacks such as reversion to virulent forms was soon realized. Leishmania tarentolae with capacity of adaptation to mammalian system has a potential to be used as nonpathogenic vector in vaccine programs. Due to its nonpathogenic Keywords intrinsic property, it does not have the ability to replace with the pathogen form. ► Leishmania Moreover, the main problems are associated with the production of live vaccines, ► leishmaniasis including lyophilization, storage, standards, and quality control that must be consid- ► live-attenuated ered. In this review, we focused on the importance of different approaches concerning ► vaccine the development of a live vaccine against leishmaniasis. received DOI https://doi.org/ © 2021. The Author(s). August 29, 2020 10.1055/s-0041-1731336. This is an open access article published by Thieme under the terms of the accepted after revision ISSN 2474-5871. Creative Commons Attribution License, permitting unrestricted use, May 14, 2021 distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/) Georg Thieme Verlag KG, Rüdigerstraße 14, 70469 Stuttgart, Germany Development of Live Vaccine against Leishmaniasis Feiz Haddad et al. e179 Introduction Table 1 Development status of current vaccine candidates Leishmaniasis, caused by an intracellular protozoan para- Candidate Preclinical Phase Phase Reference sites of the genus Leishmania, is prevalent in subtropical and name/identifier I II – tropical regions all around the world.1 3 The disease is LEISH-F2 X 11,25 considered as neglected tropical diseases with the incidence LEISH-F3 X 11,26 4,5 of 1.5 million new cases annually which leads to a consid- 11,27 6 Various Lutzomyia and X erable mortality and morbidity. There are three main forms flyantigens of the disease, namely, cutaneous leishmaniasis (CL), visceral Various second- X 11,27 leishmaniasis (VL), and mucocutaneous leishmaniasis generation protein- 7 (MCL). VL, also known as kala-azar, is caused by Leishmania based vaccines donovani (anthroponotic form) and L. infantum (zoonotic Various third- X 11,27 form). VL is the most important and severe form of leish- generation DNA- maniasis with 500,000 new cases annually. In this form of the based and disease, the parasites invade in internal organs such as liver heterologous prime- and spleen. VL can lead to death in untreated cases and there boost vaccines is no effective vaccine for it.8 MCL is mainly caused by L. braziliensis complex in mucosal tissues of nose and mouth and can result in massive tissue damage and permanent disfiguration.9 CL is self-healing disease10 caused mostly by against human leishmaniasis, even several vaccines have the L. tropica and L. major in the Central Asia and Middle developed to clinical trials, most are still in early research – East11 and L. braziliensis and L. mexicana complexes in the phases and need more develop (►Table 1).25 27 From 2004, Americas.12 CL is the most common form of leishmaniasis in four vaccines have been licensed against canine leishmanio- the world, and 90% of all CL cases occur only in seven sis, two in Brazil (Leishmune, license was withdrawn in 2014, countries: Syria, Iran, Saudi Arabia, Algeria, Peru, Brazil, and Leish-Tec) and two in Europe (CaniLeish and LetiFend).28 and Afghanistan.1 CL can lead to skin deformities, and in Efforts for finding an effective vaccine against leishmaniasis immune compromised patients giving rise to the diffuse is continuing worldwide.9,29 Finally, development of an cutaneous leishmaniasis.13 The host immune response has effective vaccine is one of the most cost-effective ways to a crucial role in leishmaniasis, both in efficacy of treatment eliminate and/or control CL and VL. This review aims to and the clinical patterns of the disease.14 Success in devel- discuss the importance of different approaches concerning opment of vaccine depends on selecting an appropriate the development of a live-attenuated vaccine against vaccine candidate and the immune biology of leishmaniasis. pathogen/host interactions.15 Cell-mediated immunity par- ticularly CD4 T cells are critical in leishmaniasis and protec- Live Active Vaccines tion against the disease.16 The host defense mainly relies on response of Th1 cells which were activated through interleu- Leishmanization (LZ) was the first effort in using live parasite kin (IL)-12. Antigen presenting cells (APCs) and T cells, as they for human immunization, which was used in some countries produce IL-12 and interferon gamma (IFN-γ), are crucial for for immunization against CL. There is a constant concern limiting the numbers of leishmania parasites.17 In contrast, about revision to virulent type. This method was used in last Th2 cells produce cytokines, mainly IL-4, IL-5, and IL-13 and century in several countries particularly in the Middle East, anti-inflammatory cytokines that have suppressive effect on but it countered severe barriers such as local lesions in 2 to host immunity which leads to parasite survival during 3% of cases. The program was stopped due to some problems leishmaniasis.17,18 These effects are exclusively studied in such as spreading the HIV infection, increasing the use of CL and murine models.7,19 Generation of proper immuno- immunosuppressive drugs, permanent skin lesions, dissem- logic memory is the main challenge in designing a vaccine ination of lesions, ethical reasons, and problems in quality that can cause effective immunity. Different studies revealed control of inoculant and long-lasting parasite persistence. that long-lasting immunity against leishmaniasis needs to Uzbekistan is one of the endemic countries, which LZ is involve the function of both regulatory T cells (Tregs) and licensed and its efficacy in human trials was proven. Efforts Th1-mediated immune response.20,21 Currently, treatment for improving the safety of this practice is continuing as this of any form of leishmaniasis is remarkably dependent on program can lead to an efficient vaccine against CL. It is pentavalent antimonials as first-line and amphotericin B declared that under controlled condition, it is achievable to as second-line drugs.22 This treatment is usually adequate elicit quick immune responses using the killed parasites and but long duration of treatment, high costs, and side effects adjuvants.30 are still challenging. Reversion to virulence form has been reported in host with weak immune system, especially in Live-Attenuated Vaccine HIV infected individuals.23 Furthermore, strains which are resistant to available drugs created the need for an effective Several methods such as long-term in vitro cultures,31 atten- vaccine.24 Currently, there is no impermissible vaccine uation with temperature,32 chemical mutagenesis,33,34 Journal of Child Science Vol. 11 No. 1/2021 © 2021. The Author(s). e180 Development of Live Vaccine against Leishmaniasis Feiz Haddad et al. culture under drug pressure,35 and γ-attenuation have been through mimicking natural infection and lead to the highest used to develop an attenuated Leishmania strains for many rate of CD4þ Tcellspolarization.55 Also, it evaluates the years. Recently, live-attenuated mutants through the gene memory of the immune system due to delivery of whole alteration have revealed ability to induce proper immune antigens instead of its subunits, and finally, they cause responses in experimental hosts (►Table 2). This helps antigen constancy through long time subclinical infection.
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