Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Vaccine. 2020 Jun 15;38(29):4592-4600. doi: 10.1016/j.vaccine.2020.05.008. Epub 2020 May 19.
PfSPZ Vaccine, composed of radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, is administered by direct venous inoculation (DVI) for maximal efficacy against malaria. A critical issue for advancing vaccines that are administered intravenously is the ability to efficiently administer them across multiple age groups. As part of a pediatric safety, immunogenicity, and efficacy trial in western Kenya, we evaluated the feasibility and tolerability of DVI, including ease of venous access, injection time, and crying during the procedure across age groups. Part 1 was an age de-escalation, dose escalation trial in children aged 13 months-5 years and infants aged 5-12 months; part 2 was a vaccine efficacy trial including only infants, using the most skilled injectors from part 1. Injectors could use a vein viewer, if needed. A total of 1222 injections (target 0.5 mL) were initiated by DVI in 511 participants (36 were 5-9-year-olds, 65 were 13-59-month-olds, and 410 infants). The complete volume was injected in 1185/1222 (97.0%) vaccinations, 1083/1185 (91.4%) achieved with the first DVI. 474/511 (92.8%) participants received only complete injections, 27/511 (5.3%) received at least one partial injection (<0.5 mL), and in 10/511 (2.0%) venous access was not obtained. The rate of complete injections by single DVI for infants improved from 77.1% in part 1 to 92.8% in part 2. No crying occurred in 51/59 (86.4%) vaccinations in 5-9-year-olds, 25/86 (29.1%) vaccinations in 13-59-month-olds and 172/1067 (16.1%) vaccinations in infants. Mean administration time ranged from 2.6 to 4.6 minutes and was longer for younger age groups. These data show that vaccination by DVI was feasible and well tolerated in infants and children in this rural hospital in western Kenya, when performed by skilled injectors. We also report that shipping and storage in liquid nitrogen vapor phase was simple and efficient. (Clinicaltrials.gov NCT02687373).
PfSPZ 疫苗由经过辐射减毒、无菌、纯化、冷冻保存的恶性疟原虫孢子组成，通过直接静脉接种（DVI）进行给药，以实现对疟疾的最大疗效。对于静脉内给药的疫苗，一个关键问题是能够有效地在多个年龄组中进行给药。作为在肯尼亚西部进行的儿科安全性、免疫原性和疗效试验的一部分，我们评估了 DVI 的可行性和耐受性，包括静脉穿刺的便利性、注射时间和各年龄段的哭泣情况。第 1 部分是在 13 个月至 5 岁的儿童和 5-12 个月的婴儿中进行的年龄递减、剂量递增试验；第 2 部分是一项仅包括婴儿的疫苗效力试验，使用第 1 部分中最熟练的注射者。如果需要，注射者可以使用静脉可视仪。在 511 名参与者中，共进行了 1222 次 DVI 注射（目标剂量为 0.5ml）（36 名参与者为 5-9 岁，65 名参与者为 13-59 个月，410 名婴儿）。在 1222 次接种中，1185 次（97.0%）完全注射了疫苗，其中 1083 次（91.4%）是通过第一次 DVI 注射完成的。474/511（92.8%）名参与者仅接受了完全注射，27/511（5.3%）名参与者至少接受了一次部分注射（<0.5ml），而 10/511（2.0%）名参与者未能获得静脉通路。在第 1 部分中，婴儿单次 DVI 的完全注射率从 77.1%提高到第 2 部分的 92.8%。在 5-9 岁的儿童中，51/59（86.4%）次接种中没有哭泣，在 13-59 个月的儿童中，25/86（29.1%）次接种中没有哭泣，在婴儿中，172/1067（16.1%）次接种中没有哭泣。平均给药时间为 2.6 至 4.6 分钟，年龄越小时间越长。这些数据表明，在肯尼亚西部的一家农村医院，由熟练的注射者进行 DVI 接种，在婴儿和儿童中是可行的，并且耐受性良好。我们还报告说，在液氮气相中的运输和储存非常简单高效。（Clinicaltrials.gov NCT02687373）
