Leishmanization: Use of an old method for evaluation of candidate vaccines against leishmaniasis
VaccinePublished 11 March 2005
Ali Khamesipour, Yahya Dowlati, Ali Asilian, R. Hashemi‐Fesharki, Amir Javadi, Sassan Noazin
Citations205
SJR quartileQ1
SJR score1.25
SNIP0.97
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TL;DR
LZ used as live challenge to test vaccine candidates reduces the required sample size, is cost effective for surrogate markers studies and will induce protection in the participants who are not protected by candidate vaccines.
Abstract
To establish the safety and reproducibility of live challenge with Leishmania major, a single frozen stabilate was used in two open, single-arm leishmanization (LZ) trials. A total of 42 inoculations in 28 male adult volunteers were followed until complete healing. Lesions induced by LZ are as diverse as natural infection, but much milder. Total protection was seen in 100% (11/11) of recovered volunteers. LZ used as live challenge to test vaccine candidates reduces the required sample size, is cost effective for surrogate markers studies and will induce protection in the participants who are not protected by candidate vaccines.
Keywords
Medicine
New England Journal of MedicineMeasurement of Delayed Skin-Test Responses
505 Citations1975Joseph E. Sokal
ScienceIdentification of an Infective Stage of <i>Leishmania</i> Promastigotes
498 Citations1984David L. Sacks, Peter V. Perkins
Sequential development of Leishmania promastigotes from a noninfective to an infective stage was demonstrated and the generation of an infected stage was found to be growth cycle-dependent and restricted to nondividing organisms.
The LancetRandomised vaccine trial of single dose of killed Leishmania major plus BCG against anthroponotic cutaneous leishmaniasis in Bam, Iran
237 Citations1998Iraj Sharifi, Alireza Fekri +10 more
A single dose of ALM + BCG was safe and more immunogenic than BCG alone, as measured by leishmanin skin test, and the preferential protective effect in boys may have resulted from a greater booster effect produced by repeated exposure to infected sandflies.
The LancetAutoclaved Leishmania major vaccine for prevention of visceral leishmaniasis: a randomised, double-blind, BCG-controlled trial in Sudan
234 Citations2000EAG Khalil, A. M. A. El Hassan +9 more
It was found no evidence that two doses of ALM plus BCG offered significant protective immunity against visceral leishmaniasis compared with BCG alone, andLeishmanin skin conversion with an induration of 5 mm or more in either group was associated with protection from the disease.
Infection and ImmunityRandomized, Double-Blind, Placebo-Controlled, Multicentered Trial of the Efficacy of a Single Dose of Live Oral Cholera Vaccine CVD 103-HgR in Preventing Cholera following Challenge with <i>Vibrio cholerae</i> O1 El Tor Inaba Three Months after Vaccination
173 Citations1999Carol O. Tacket, Mitchell B. Cohen +10 more
This vaccine was well tolerated and immunogenic in double-blind, controlled studies and was protective in open-label studies of volunteers challenged with V. cholerae El Tor Inaba, suggesting it could be a safe and effective tool to prevent cholera in travelers.
The Journal of ImmunologyProtective Immunity Using Recombinant Human IL-12 and Alum as Adjuvants in a Primate Model of Cutaneous Leishmaniasis
154 Citations1999Richard T. Kenney, David L. Sacks +4 more
A single dose vaccine with killed Ag using rhIL-12 and alum as adjuvants was safe and fully effective in this primate model of cutaneous leishmaniasis, and provides a basis for further human trials.
VaccineA randomised, double-blind, controlled trial of a killed L. major vaccine plus BCG against zoonotic cutaneous leishmaniasis in Iran
150 Citations1999Ali Momeni, T Jalayer +14 more
A single dose of ALM + BCG is not sufficiently immunogenic to provide a measurable response when compared to BCG alone; hence, multiple doses or other adjuvants should be considered to increase its immunogenicity.
International Journal of EpidemiologyControlled Field Trials of a Vaccine Against New World Cutaneous Leishmaniasis
140 Citations1986Carlos Antunes, Wilson Mayrink +9 more
Two controlled, double blind field trials of a non-living promastigote vaccine against New World Cutaneous Leishmaniasis (NWCL) were conducted in 1981 and 1983 in Brazil and showed no significant differences between the vaccine and the placebo groups.
PubMedEffectiveness of leishmanization in the control of cutaneous leishmaniasis.
128 Citations1983A Nadim, E Javadian +2 more
It is concluded that leishmanized skin test two years after inoculation has a protective effect of about 80% in this endemic area.
Clinics in DermatologyEpidemiology of cutaneous leishmaniasis
125 Citations1999Sidney N. Klaus
It is now clear that only by recognizing the complexity of this group of diseases—including the intricate patterns of interaction between hosts, reservoirs, and vectors—can progress be made in formulating effective methods of control.
The Journal of Infectious DiseasesField Trial of a Vaccine against New World Cutaneous Leishmaniasis in an At‐Risk Child Population: Safety, Immunogenicity, and Efficacy during the First 12 Months of Follow‐Up
98 Citations1998Rodrigo X. Armijos, M. Margaret Weigel +3 more
The safety, immunogenicity, and efficacy of a vaccine against cutaneous leishmaniasis in rural Ecuadorian children was assessed in a randomized, controlled, double-blinded study.
VaccineSuccessful vaccination against Leishmania donovani infection in Indian langur using alum-precipitated autoclaved Leishmania major with BCG
95 Citations2001Alka Misra, Anuradha Dube +5 more
Alum-precipitated ALM+BCG is suggested as a potential vaccine against visceral leishmaniasis and warrants clinical trials, indicating IFN-gamma response as a sensitive parameter of immune status.
ParasitologyExperiences with vaccines against cutaneous leishmaniasis: of men and mice
93 Citations1989Farrokh Modabber
It is suggested that a vaccine against cutaneous leishmaniasis, at least against L. major, is imminent in the not too distant future.
PubMedTreatment of cutaneous leishmaniasis with aminosidine (paromomycin) ointment: double-blind, randomized trial in the Islamic Republic of Iran.
82 Citations2003Ali Asilian, T Jalayer +6 more
Although about half of those cured might have recovered spontaneously even without treatment, four weeks of aminosidine ointment could become the first-line treatment for uncomplicated cutaneous leishmaniasis due to L. major, with antimonials needed in only the one-third of patients not cured by the end of treatment withAminosidine.
PubMedEpidemiology of cutaneous leishmaniasis in Iran: B. Khorassan Part V: Report on a focus of zoonotic cutaneous leishmaniasis in Esferayen.
80 Citations1977E Javadian, A Nadim +2 more
During August and September 1975, an epidemiological investigation was carried out in another focus of cutaneous leishmaniasis in Khorassan province namely the Esferayen district located in the north western part of this province.
Clinics in DermatologyComparative safety and immunogenicity trial of two killed Leishmania Major vaccines with or without BCG in human volunteers
65 Citations1996Kamal Bahar, Yahya Dowlati +7 more
American Journal of Tropical Medicine and HygieneVolunteer Studies Investigating the Safety and Efficacy of Live Oral El Tor Vibrio cholerae O1 Vaccine Strain CVD 111
56 Citations1997C O Tacket, Karen L. Kotloff +6 more
A live oral cholera vaccine should ideally protect against both classical and El Tor biotypes of Vibrio cholerae O1, and this study vaccinated 25 healthy adult volunteers against El Tor vaccine strain CVD 111, a derivative of El Tor Ogawa strain N16117 deleted in the virulence cassette.
PubMedComparison of topical paromomycin sulfate (twice/day) with intralesional meglumine antimoniate for the treatment of cutaneous leishmaniasis caused by L. major.
54 Citations2005Babak Shazad, Babak Abbaszadeh +1 more
This is an open study to compare the cure rate of cutaneous leishmaniasis caused by L. major treated with either paromomycin sulfate or intralesional injection of meglumine antimoniate with results showing no significant difference.
VaccineImmunogenicity and safety of autoclaved Leishmania major plus BCG vaccine in healthy Sudanese volunteers
50 Citations2001Iman Satti, H Y. Osman +6 more
The vaccine produced significant cellular immune responses that may protect against natural challenge and none of the groups had systemic reactions and all the reactions observed in the vaccinated group were comparable with the BCG-vaccinated group.
Clinical & Experimental ImmunologyImmune response measured in human volunteers vaccinated with autoclaved<i>Leishmania major</i>vaccine mixed with low dose of BCG
46 Citations2003Majid Mahmoodi, Ali Khamesipour +6 more
The data suggest that a single dose of ALM + BCG induces a weak Th1 response in vaccinated volunteers that is far lower than that in volunteers with prior subclinical infection or volunteers with history of CL, who are presumed to be immune.
Transactions of the Royal Society of Tropical Medicine and HygieneArtificial infection and immunization of man with cultures of Leishmania tropica
37 Citations1941H.A. Senekji, C. P. Beattie
Experimental ParasitologySelective Killing ofLeishmaniaAmastigotes Expressing a Thymidine Kinase Suicide Gene
35 Citations1997Anthony Muyombwe, Martin Olivier +2 more
The thymidine kinase gene of Herpes simplex type-1 virus was transfected into several Leishmania species to create drug-sensitive mutants to suggest novel strategies for controlling parasitic infections.
Clinics in DermatologyStepwise safety trial of a killed Leishmania vaccine in Iran
27 Citations1996Yahya Dowlati, Siemin Ehsasi +2 more
Efforts to protect people against leish maniasis have a long historical background, such as leishmanization of Kurds and Bedouins, and recent experience with leishManization took place in Iran, where about 2,000,OOO individuals were included in the program.
PubMedDevelopment of a storable Leishmania tropica vaccine: field testing with frozen promastigotes.
13 Citations1979Eliezer Witztum, Charles L. Greenblatt +4 more
The development of a frozen vaccine against cutaneous leishmaniasis offers the possibility of controlling the quality, efficiency and sterility of the promastigotes used for inoculation, as well as the different responses of men and women.
Journal of Biological StandardizationAn improved protocol for the preparation of a frozen promastigote vaccine for cutaneous leishmaniasis
11 Citations1980Charles L. Greenblatt, Dan T. Spira +2 more
A simple protocol for freezing the promastigote vaccine in liquid nitrogen is described, which allows prolonged storage of the material in the final container and tests of biochemical identity, sterility, pyrogenicity and infectivity for animals and cultured cells are carried out.
Transactions of the Royal Society of Tropical Medicine and HygieneOriental sore and immunity against it
11 Citations1924E. I. Marzinowsky, A. Schurenkowa