{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T07:04:52Z","timestamp":1784790292507,"version":"3.55.0"},"reference-count":42,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T00:00:00Z","timestamp":1784764800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Science, Technology and Innovation (STI) Secretariat through the Office of the President (OP) of Uganda"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background: Adenoviral vectors are widely used in vaccine development; however, pre-existing immunity to common human adenovirus serotypes can limit their effectiveness. Canine adenovirus type 2 (CAV-2) is a non-human adenovirus with low seroprevalence in humans, making it a suitable alternative vector. Despite its promise, comprehensive preclinical safety data for CAV-2 vector-based vaccine platforms remain limited. In this study, we evaluated the safety profile of a replication-defective CAV-2 vector expressing the Omicron BA.4 SARS-CoV-2 spike immunogen in BALB\/c mouse models. Methods: The SARS-CoV-2 CAV-2 vector-based vaccine was expressed and propagated in AD293 cells. The mice received intramuscular prime-boost immunisations with low (1 \u00d7 106 PFU), moderate (0.5 \u00d7 1010 PFU), or high (1 \u00d7 1010 PFU) vaccine doses, alongside empty CAV-2 vector and physiological buffer control groups, and were monitored longitudinally up to Day 72. The mice were clinically assessed at days 0, 7, 21, 42, and 72 for any deviations from normal conditions in comparison to the control groups. Biochemical analyses were performed to evaluate liver and kidney function, as well as any tissue injury due to the vaccine candidate. Hematological parameters were assessed by conducting complete blood counts. Body temperature and weight changes were also monitored as an indicator of systemic toxicity. Results: The biochemical and haematological parameters remained within physiological reference ranges across all dose groups and timepoints, with no dose-related deviations, indicating that the vaccine candidate did not show evidence of hepatotoxicity, nephrotoxicity, tissue or haematological toxicity. Body temperatures remained within normal physiological ranges following both prime and booster immunisations, and body weights increased normally across all groups as the animals grew throughout the study period without any abnormal weight gain or loss. Conclusions: These results suggest that the replication-defective CAV-2-vectored SARS-CoV-2 vaccine candidate was well tolerated and did not demonstrate evidence of systemic toxicity under the conditions tested. These findings demonstrate that the CAV-2 vector exhibits a favourable safety profile in murine models when used as a vaccine delivery platform, supporting its translational potential as an alternative adenoviral vector-based vaccine platform. Further studies incorporating additional safety endpoints, including histopathological, vector persistence and shedding evaluation, are warranted to support continued development of the platform.<\/jats:p>","DOI":"10.3390\/vaccines14080647","type":"journal-article","created":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T06:11:42Z","timestamp":1784787102000},"page":"647","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Preclinical Safety Evaluation of a Replication-Defective Canine Adenovirus Type 2 Vector-Based SARS-CoV-2 Vaccine Candidate in Murine Models"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7936-1754","authenticated-orcid":false,"given":"Denis","family":"Omara","sequence":"first","affiliation":[{"name":"Uganda Virus Research Institute (UVRI), Entebbe P.O. Box 49, Uganda"},{"name":"Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala P.O. Box 7062, Uganda"},{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Ndekezi","sequence":"additional","affiliation":[{"name":"Uganda Virus Research Institute (UVRI), Entebbe P.O. Box 49, Uganda"},{"name":"Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala P.O. Box 7062, Uganda"},{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Mugaba","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2866-5998","authenticated-orcid":false,"given":"Angella","family":"Nakyanzi","sequence":"additional","affiliation":[{"name":"Uganda Virus Research Institute (UVRI), Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fortunate","family":"Natwijuka","sequence":"additional","affiliation":[{"name":"Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala P.O. Box 7062, Uganda"},{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0726-1276","authenticated-orcid":false,"given":"Anne","family":"Kapaata","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5075-0756","authenticated-orcid":false,"given":"Frank","family":"Kato","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Drake","family":"Byamukama","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E.","family":"Ggwaabya","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orla","family":"Mugulusi","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Freddie","family":"Bwanga","sequence":"additional","affiliation":[{"name":"Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala P.O. Box 7062, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David P.","family":"Katete","sequence":"additional","affiliation":[{"name":"Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala P.O. Box 7062, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enock","family":"Matovu","sequence":"additional","affiliation":[{"name":"Central Laboratory for Animal Research Facility (CLARF), College of Veterinary Medicine, Animal Resources and Biosecurity (COVAB), Makerere University, Kampala P.O. Box 7062, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Olobo","sequence":"additional","affiliation":[{"name":"Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala P.O. Box 7062, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekii Andrew","family":"Obuku","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2301-5980","authenticated-orcid":false,"given":"Obondo James","family":"Sande","sequence":"additional","affiliation":[{"name":"Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala P.O. Box 7062, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Serwanga","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5156-037X","authenticated-orcid":false,"given":"Stephen","family":"Cose","sequence":"additional","affiliation":[{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pontiano","family":"Kaleebu","sequence":"additional","affiliation":[{"name":"Uganda Virus Research Institute (UVRI), Entebbe P.O. Box 49, Uganda"},{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8374-3122","authenticated-orcid":false,"given":"Sheila N.","family":"Balinda","sequence":"additional","affiliation":[{"name":"Uganda Virus Research Institute (UVRI), Entebbe P.O. Box 49, Uganda"},{"name":"Medical Research Council\/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC\/UVRI & LSHTM), Uganda Research Unit, Entebbe P.O. Box 49, Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"546","DOI":"10.1016\/j.copbio.2007.10.010","article-title":"Replicating and non-replicating viral vectors for vaccine development","volume":"18","year":"2007","journal-title":"Curr. Opin. Biotechnol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"e6","DOI":"10.4110\/in.2021.21.e6","article-title":"Adenovirus vectors: Excellent tools for vaccine development","volume":"21","author":"Chang","year":"2021","journal-title":"Immune Netw."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Murala, M.S., Gairola, V., Sayedahmed, E.E., and Mittal, S.K. (2025). Next-Generation Adenoviral Vector-Based Vaccines for Severe Acute Respiratory Syndrome Coronavirus-2. 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