Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group
Background: Canine visceral leishmaniasis (CVL) is not only an emerging veterinary concern but also a public health threat in endemic areas. The aim of this study was to assess the efficacy, immunogenicity and safety of two doses of aluminum hydroxide (alum) precipitated Leishmania major (Alum-ALM)...
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| Format: | Article |
| Language: | English |
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Tehran University of Medical Sciences
2015-10-01
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| Series: | Iranian Journal of Parasitology |
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| Online Access: | https://ijpa.tums.ac.ir/index.php/ijpa/article/view/300 |
| _version_ | 1818903903598542848 |
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| author | Mohammad BARATI Mehdi MOHEBALI Mohammad Hossein ALIMOHAM¬MADIAN Ali KHMESIPOUR Hossein KESHAVARZ Behnaz AKHOUNDI Zabi¬hollah ZAREI |
| author_facet | Mohammad BARATI Mehdi MOHEBALI Mohammad Hossein ALIMOHAM¬MADIAN Ali KHMESIPOUR Hossein KESHAVARZ Behnaz AKHOUNDI Zabi¬hollah ZAREI |
| author_sort | Mohammad BARATI |
| collection | DOAJ |
| description | Background: Canine visceral leishmaniasis (CVL) is not only an emerging veterinary concern but also a public health threat in endemic areas. The aim of this study was to assess the efficacy, immunogenicity and safety of two doses of aluminum hydroxide (alum) precipitated Leishmania major (Alum-ALM) mixed with BCG plus imiquimod against CVL.
Methods: A total of 560 ownership dogs were serologically tested and 234 healthy dogs with no clinical signs of CVL, no anti-Leishmania antibodies and negative leishmanin skin test were selected and double-blind randomly injected intradermally either with 0.1 ml Alum-ALM (200µg protein) mixed with BCG (2 × 106 CFUs) plus imiquimod (121 dogs) or with 0.1 ml of normal saline (113 dogs).
Results: The follow-up examinations showed that there was no side effect associated with the vaccination except one case. Strong skin test conversion were seen in vaccinated group (30.3%) compared to the control group (6.6%) at 22-24 weeks after the booster injection (p<0.001). The seroconversion was 16.3% (18/110) in vaccinated group and 26.4% (28/106) in control group after two transmission cycles but the difference was not significant (P=0.095). The efficacy rate based on seroconversion was 40.4 %.
Conclusion: Two injections of Alum-ALM mixed with BCG and imiquimod is safe, although decreases the seroconversion rate of CVL, but the overall efficacy was low. |
| first_indexed | 2024-12-19T20:58:56Z |
| format | Article |
| id | doaj.art-8d2760155cb7405580c7d634d572953f |
| institution | Directory Open Access Journal |
| issn | 1735-7020 2008-238X |
| language | English |
| last_indexed | 2024-12-19T20:58:56Z |
| publishDate | 2015-10-01 |
| publisher | Tehran University of Medical Sciences |
| record_format | Article |
| series | Iranian Journal of Parasitology |
| spelling | doaj.art-8d2760155cb7405580c7d634d572953f2022-12-21T20:05:53ZengTehran University of Medical SciencesIranian Journal of Parasitology1735-70202008-238X2015-10-01103279Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control GroupMohammad BARATI0Mehdi MOHEBALI1Mohammad Hossein ALIMOHAM¬MADIAN2Ali KHMESIPOUR3Hossein KESHAVARZ4Behnaz AKHOUNDI5Zabi¬hollah ZAREI6Dept. of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran AND Center for Research of Infectious Diseases, AJA University of Medical Sciences, Tehran, IranDept. of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran AND Center for Research of Endemic Parasites of Iran (CREPI), Tehran University of Medical Sciences, Tehran, IranDept. of Immunology, Pasteur Institute of Iran, Tehran, IranCenter for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, IranDept. of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, IranDept. of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, IranMeshkin-Shahr Research station, School of Public Health, Tehran University of Medical Sciences, IranBackground: Canine visceral leishmaniasis (CVL) is not only an emerging veterinary concern but also a public health threat in endemic areas. The aim of this study was to assess the efficacy, immunogenicity and safety of two doses of aluminum hydroxide (alum) precipitated Leishmania major (Alum-ALM) mixed with BCG plus imiquimod against CVL. Methods: A total of 560 ownership dogs were serologically tested and 234 healthy dogs with no clinical signs of CVL, no anti-Leishmania antibodies and negative leishmanin skin test were selected and double-blind randomly injected intradermally either with 0.1 ml Alum-ALM (200µg protein) mixed with BCG (2 × 106 CFUs) plus imiquimod (121 dogs) or with 0.1 ml of normal saline (113 dogs). Results: The follow-up examinations showed that there was no side effect associated with the vaccination except one case. Strong skin test conversion were seen in vaccinated group (30.3%) compared to the control group (6.6%) at 22-24 weeks after the booster injection (p<0.001). The seroconversion was 16.3% (18/110) in vaccinated group and 26.4% (28/106) in control group after two transmission cycles but the difference was not significant (P=0.095). The efficacy rate based on seroconversion was 40.4 %. Conclusion: Two injections of Alum-ALM mixed with BCG and imiquimod is safe, although decreases the seroconversion rate of CVL, but the overall efficacy was low.https://ijpa.tums.ac.ir/index.php/ijpa/article/view/300AlumLeishmania majorVaccineCanine visceral leish-maniasisBCGImiquimod |
| spellingShingle | Mohammad BARATI Mehdi MOHEBALI Mohammad Hossein ALIMOHAM¬MADIAN Ali KHMESIPOUR Hossein KESHAVARZ Behnaz AKHOUNDI Zabi¬hollah ZAREI Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group Iranian Journal of Parasitology Alum Leishmania major Vaccine Canine visceral leish-maniasis BCG Imiquimod |
| title | Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group |
| title_full | Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group |
| title_fullStr | Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group |
| title_full_unstemmed | Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group |
| title_short | Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group |
| title_sort | double blind randomized efficacy field trial of alum precipitated autoclaved leishmania major alum alm vaccine mixed with bcg plus imiquimod vs placebo control group |
| topic | Alum Leishmania major Vaccine Canine visceral leish-maniasis BCG Imiquimod |
| url | https://ijpa.tums.ac.ir/index.php/ijpa/article/view/300 |
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