A phase I COVID-19 vaccine trial among SARS-CoV-2 seronegative and seropositive individuals in Uganda utilizing a self-amplifying RNA vaccine platform: Screening and enrollment experiences.
A phase I COVID-19 vaccine trial among SARS-CoV-2 seronegative and seropositive individuals in Uganda utilizing a self-amplifying RNA vaccine platform: Screening and enrollment experiences.
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DOI：
10.1080/21645515.2023.2240690
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发表时间：
2023-08-01
影响因子：
4.8
通讯作者：
Kaleebu, Pontiano
中科院分区：
文献类型：
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作者：
Kitonsa, Jonathan;Kamacooko, Onesmus;Ruzagira, Eugene;Nambaziira, Florence;Abaasa, Andrew;Serwanga, Jennifer;Gombe, Ben;Lunkuse, Jane;Naluyinda, Hadijah;Tukamwesiga, Naboth;Namata, Tamara;Kigozi, Antony;Kafeero, Paddy;Basajja, Vincent;Joseph, Sarah;Pierce, Benjamin F.;Shattock, Robin;Kaleebu, Pontiano
我们报告了在乌干达马萨卡进行的 I 期疫苗试验的筛选和招募过程，该试验研究了自放大 SARS-CoV-2 RNA 疫苗在具有和不具有 SARS-CoV-2 抗体的个体中的安全性和免疫原性。参与者筛选和登记于 2021 年 12 月至 2022 年 4 月期间进行。如果个人年龄在 18 岁至 45 岁之间、身体健康且从未接种过 COVID-19 疫苗，则符合资格。 SARS-CoV-2 抗体状态通过两种即时快速检测确定，即 Multi G (MGFT3) 和 Standard Q（Standard Q COVID-19 IgM/IgG Plus）。数据在 OpenClinica 中输入和管理。进行了分析并进行了描述性呈现。共有 212 人接受筛查，43 人（20.3%）入组。最常见的排除原因是 ≥ 1 级实验室异常（39 例，18.4%），其次是 SARS-CoV-2 抗体结果不一致（23 例，10.9%）。虽然前 38 名参与者在 9 周内迅速入组，但由于在 Omicron 变种激增期间抗体阴性参与者变得稀缺，因此又花了 9 周才入组剩余 5 名参与者。在 18 个月的筛查中，SARS-CoV-2 抗体阳性率分别为 60.8% 和 84.4%。筛选和登记参与者的平均年龄（±标准差，SD）分别为 27.7 (±8.1) 和 30.2 (±8.3) 岁。我们证明，在大流行期间，在乌干达成功筛选和招募参加 COVID-19 疫苗试验的参与者是可行的。我们的经验可能对计划在非洲开展类似工作的研究人员有用。
We report the screening and enrollment process for a phase I vaccine trial in Masaka, Uganda that investigated the safety and immunogenicity of a self-amplifying SARS-CoV-2 RNA vaccine amongst individuals with and without antibodies to SARS-CoV-2. Participant screening and enrollment were conducted between December 2021 and April 2022. Individuals were eligible if they were aged between 18 and 45 years, healthy, and never vaccinated against COVID-19. SARS-CoV-2 antibody status was determined using two point-of-care rapid tests, i.e. Multi G (MGFT3) and Standard Q (Standard Q COVID-19 IgM/IgG Plus). Data were entered and managed in OpenClinica. Analyses were performed and presented descriptively. A total of 212 individuals were screened and 43(20.3%) enrolled. The most common reasons for exclusion were ≥ grade 1 laboratory abnormalities (39, 18.4%), followed by discordant SARS-CoV-2 antibody results (23, 10.9%). While the first 38 participants were quickly enrolled over a period of 9 weeks, it took another 9 weeks to enroll the remaining five, as antibody negative participants became scarce during the surge of the Omicron variant. The SARS-CoV-2 antibody positivity rate was determined to be 60.8% and 84.4% in each half of the 18 months of screening respectively. The mean age (±Standard Deviation, SD) of screened and enrolled participants was 27.7 (±8.1) and 30.2 (±8.3) years respectively. We demonstrated that it is feasible to successfully screen and enroll participants for COVID-19 vaccine trials in Uganda in the time of a pandemic. Our experiences may be useful for investigators planning to undertake similar work in Africa.
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影响因子：
11.8
作者：
通讯作者：
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影响因子：
9.9
作者：
He X;Hong W;Pan X;Lu G;Wei X
通讯作者：
Wei X
DOI：
10.1016/s0140-6736(22)00007-1
发表时间：
2022-03-19
期刊：
Lancet (London, England)
影响因子：
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作者：
Bekker LG;Garrett N;Goga A;Fairall L;Reddy T;Yende-Zuma N;Kassanjee R;Collie S;Sanne I;Boulle A;Seocharan I;Engelbrecht I;Davies MA;Champion J;Chen T;Bennett S;Mametja S;Semenya M;Moultrie H;de Oliveira T;Lessells RJ;Cohen C;Jassat W;Groome M;Von Gottberg A;Le Roux E;Khuto K;Barouch D;Mahomed H;Wolmarans M;Rousseau P;Bradshaw D;Mulder M;Opie J;Louw V;Jacobson B;Rowji P;Peter JG;Takalani A;Odhiambo J;Mayat F;Takuva S;Corey L;Gray GE;Sisonke Protocol Team;Sisonke Study Team
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Sisonke Study Team
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作者：
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通讯作者：
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非洲Covid-19研究的文献计量分析。
影响因子：
8.1
作者：
Guleid FH;Oyando R;Kabia E;Mumbi A;Akech S;Barasa E
通讯作者：
Barasa E