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Open-label phase I clinical trial of Ad5-EBOV in Africans in China.

ABSTRACT: To determine the safety and immunogenicity of a novel recombinant adenovirus type 5 vector based Ebola virus disease vaccine (Ad5-EBOV) in Africans in China.A phase 1, dose-escalation, open-label trial was conducted. 61 healthy Africans were sequentially enrolled, with 31 participants receiving one shot intramuscular injection and 30 participants receiving a double-shot regimen. Primary and secondary end points related to safety and immunogenicity were assessed within 28 d after vaccination. This study was registered with ClinicalTrials.gov (NCT02401373).Ad5-EBOV is well tolerated and no adverse reaction of grade 3 or above was observed. 53 (86.89%) participants reported at least one adverse reaction within 28 d of vaccination. The most common reaction was fever and the mild pain at injection site, and there were no significant difference between these 2 groups. Ebola glycoprotein-specific antibodies appeared in all 61 participants and antibodies titers peaked after 28 d of vaccination. The geometric mean titres (GMTs) were similar between these 2 groups (1919.01 vs 1684.70 P = 0.5562). The glycoprotein-specific T-cell responses rapidly peaked after 14 d of vaccination and then decreased, however, the percentage of subjects with responses were much higher in the high-dose group (60.00% vs 9.68%, P = 0.0014). Pre-existing Ad5 neutralizing antibodies could significantly dampen the specific humoral immune response and cellular response to the vaccine.The application of Ad5-EBOV demonstrated safe in Africans in China and a specific GP antibody and T-cell response could occur 14 d after the first immunization. This acceptable safety profile provides a reliable basis to proceed with trials in Africa.

SUBMITTER: Wu L

PROVIDER: S-EPMC5612469 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Open-label phase I clinical trial of Ad5-EBOV in Africans in China.

Wu Lihua L Zhang Zhe Z Gao Hainv H Li Yuhua Y Hou Lihua L Yao Hangping H Wu Shipo S Liu Jian J Wang Ling L Zhai You Y Ou Huilin H Lin Meihua M Wu Xiaoxin X Liu Jingjing J Lang Guanjing G Xin Qian Q Wu Guolan G Luo Li L Liu Pei P Shentu Jianzhong J Wu Nanping N Sheng Jifang J Qiu Yunqing Y Chen Wei W Li Lanjuan L

Human vaccines & immunotherapeutics 20170714 9

<h4>Background</h4>To determine the safety and immunogenicity of a novel recombinant adenovirus type 5 vector based Ebola virus disease vaccine (Ad5-EBOV) in Africans in China.<h4>Methods</h4>A phase 1, dose-escalation, open-label trial was conducted. 61 healthy Africans were sequentially enrolled, with 31 participants receiving one shot intramuscular injection and 30 participants receiving a double-shot regimen. Primary and secondary end points related to safety and immunogenicity were assessed ...[more]

PMID: 28708962

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Project description:BACKGROUND:Antiangiogenesis tyrosine kinase inhibitors (TKIs) have been shown to prolong progression-free survival (PFS) in advanced osteosarcoma. Methylsulfonic apatinib is a TKI that specifically inhibits vascular endothelial growth factor receptor-2. We aim to assess apatinib in patients with advanced high-grade osteosarcoma progressing upon chemotherapy. MATERIALS AND METHODS:This phase II trial was conducted at Peking University People's Hospital. We enrolled participants (≥16 years of age) with progressive relapsed or unresectable osteosarcoma. Participants received 750 mg or 500 mg of apatinib according to body surface area once daily until disease progression or unacceptable toxicity. The primary endpoint was objective response rate and PFS at 4 months. RESULTS:A total of 37 participants were finally included into the analysis. Until final follow-up, the objective response rate (complete response + partial response) was 43.24% (16/37). The 4-month PFS rate was 56.76% (95% confidence interval [CI], 39.43%-70.84%). Median PFS and overall survival were 4.50 (95% CI, 3.47-6.27) and 9.87 (95% CI 7.97-18.93) months, respectively. Toxic effects led to dose reductions or interruptions in a total of 25 of 37 (67.57%) patients. The most common grade 3-4 adverse events were pneumothorax in six (16.22%) patients, wound dehiscence in four (10.81%), proteinuria in three (8.11%), diarrhea in three (8.11%), and palmar-plantar erythrodysesthesia syndrome in three (8.11%). No other serious adverse events were reported during the trial. There were no treatment-related deaths. CONCLUSION:Apatinib is a sensitive drug for advanced osteosarcoma with a high response rate after failure of chemotherapy, with similar duration of response compared to other TKIs. IMPLICATIONS FOR PRACTICE:For advanced osteosarcoma progressing upon chemotherapy, antiangiogenesis tyrosine kinase inhibitors (TKIs) have been proved to be effective in prolonging the progression-free survival in previous multicenter trials and have been included into new National Comprehensive Cancer Network guidelines as second-line therapy. Apatinib is a TKI that specifically inhibits vascular endothelial growth factor receptor-2, which is domestically made in China. This phase II trial supports the use of apatinib in patients with advanced osteosarcoma progressing after chemotherapy.

Dataset Information

Open-label phase I clinical trial of Ad5-EBOV in Africans in China.

Publications

Open-label phase I clinical trial of Ad5-EBOV in Africans in China.

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