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Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, a V2 specific HIV-1 broadly neutralising antibody, infused intravenously or subcutaneously in people without HIV-1 in the USA (HVTN 140/HPTN 101 part A) : a first-in-human, phase 1 randomised trial
(Elsevier, 2025-06) Seaton, Kelly E.; Paez, Carmen A.; Yu, Chenchen; Karuna, Shelly T.; Gamble, Theresa; Miner, Maurine D.; Heptinstall, Jack; Zhang, Lu; Gao, Fei; Yacovone, Margaret; Spiegel, Hans; Dumond, Julie B.; Anderson, Maija; Piwowar-Manning, Estelle; Dye, Bonnie; Tindale, India; Proulx-Burns, Lori; Trahey, Meg; Takuva, Simbarashe G.; Takalani, Azwidihwi; Bailey, Veronique C.; Kalams, Spyros A.; Scott, Hyman; Mkhize, Nonhlanhla N.; Weiner, Joshua A.; Ackerman, Margaret E.; McElrath, M. Juliana; Pensiero, Michael; Barouch, Dan H.; Montefiori, David; Tomaras, Georgia D.; Corey, Lawrence; Cohen, Myron S.; Huang, Yunda; Mahomed, Sharana; Siegel, Marc; Kelley, Colleen F.
BACKGROUND : PGDM1400LS is a human monoclonal antibody targeting the HIV envelope V2 apex with a lysine-serine modification intended to enhance serum and tissue half-lives and is being considered for use in combination monoclonal antibody trials. We sought to test whether PGDM1400LS was safe and had favourable serum concentration, pharmacokinetics, and neutralising ability in healthy adults.
METHODS : HVTN 140/HPTN 101 part A is an open-label, dose escalation, first-in-human phase 1 trial of PGDM1400LS given intravenously or subcutaneously to healthy adults aged 18–50 years without HIV-1. The study enrolled participants at four sites in the USA, across five groups, each receiving one dose of PGDM1400-LS intravenously (group 1: 5 mg/kg; group 2: 20 mg/kg; and group 4: 40 mg/kg) or subcutaneously (group 3: 20 mg/kg; and group 5: 40 mg/kg). Participants in group 1 were enrolled sequentially without random assignment. Participants in groups 2 and 3 were block randomised and enrolled simultaneously after group 1 safety review. Groups 4 and 5 followed the same process, contingent on groups 2 and 3 safety review. The primary endpoints were safety and tolerability of PGDM1400LS, serum concentration of PGDM1400LS, and serum neutralising activity after single administration of PGDM1400LS. Serum PGDM1400LS concentrations collected at seven timepoints (day 0, day 3, day 6, day 28, day 56, day 112, and day 168) were assessed via an anti-idiotype binding assay and characterised via non-compartmental pharmacokinetic analysis. Serum neutralisation activity (ID80) was assessed by a TZM-bl assay. The study is registered with ClinicalTrials.gov, NCT05184452.
FINDINGS : Between Nov 15, 2021, and March 4, 2022, 15 participants were enrolled into the five study groups (three participants per group) with 6 months of follow-up. Ten of 15 participants were female, 14 of 15 participants were non-Hispanic, and 11 of 15 participants were White, with a median age of 27 years (range 24–47). PGDM1400LS was safe and well tolerated, with mild to moderate solicited symptoms. Serum concentrations showed dose proportionality by administration route, with peak concentrations observed immediately after intravenous infusion (range 95·7–727·4 μg/mL) or on day 6 after subcutaneous infusion (205·6–547·1 μg/mL). The median elimination half-life was 55 days (range 48–59), representing a 2-to-3-times increase versus parental PDGM1400. Estimated subcutaneous (vs intravenous) bioavailability was 50–60%. ID80 titres showed agreement with concentration-predicted ID80 titres, indicating maintenance of neutralisation activity in vivo.
INTERPRETATION : PGDM1400LS is a promising candidate for combination monoclonal antibody efficacy trials going forward.
Teaching, learning and assessment of the affective domain of undergraduate students : a scoping review
(Elsevier, 2025-07) Potgieter, Lizelle; Filmalter, Cecilia Jacoba; Maree, Carin; celia.filmalter@up.ac.za
AIM : To describe the literature on the teaching, learning and assessment of the affective domain among undergraduate students across various disciplines.
BACKGROUND : Effective education integrates cognitive, psychomotor and affective development. While extensive research has addressed the teaching, learning and assessment of cognitive and psychomotor domains, considerably less attention has been given to the affective domain. The affective domain, encompassing values, ethics and emotional competencies, is essential for professional readiness yet remains a challenge in nursing education.
DESIGN : A scoping review was conducted.
METHODS : A comprehensive search was conducted following the PRISMA extension for Scoping Reviews (PRISMA-ScR) guidelines and was registered on OSF registries.
RESULTS : Twenty articles met the inclusion criteria, representing studies across 13 countries in America, Asia and Europe. No scoping review has mapped teaching and assessment of affective skills in undergraduate nursing programmes. The findings emphasized teaching and learning strategies within the affective domain but revealed a significant gap in assessment methods, particularly in nursing education.
CONCLUSIONS : Despite the recognized importance of the affective domain, existing literature predominantly addresses teaching and learning, with limited emphasis on systematic assessment strategies.
Indigenous ethno-nutraceutical plants : potential game-changers for the dual management of ruminant helminths and undernutrition in sub-Saharan Africa
(Elsevier, 2025-07) Mapiye, Cletos; Semwogerere, Farouk; Mahachi, Leo Nyikadzino; Mwale, Marizvikuru; Marufu, Munyaradzi Christopher
ETHNOPHARMACOLOGOCAL RELEVANCE : Ruminant productivity in sub-Saharan Africa (SSA) remains low largely due to helminth infections coupled with undernutrition. To jointly boost ruminant health and nutritional status, rural farmers in SSA often resort to indigenous ethno-nutraceutical plants (iENPs), which form part of folkloric practices perceived to be more accessible, affordable and effective compared with chemotherapy which is challenged by helminth resistance. However, these perceived advantages are largely unsubstantiated.
AIM OF THE STUDY : The current review aimed to 1) identify iENPs used as ruminant anthelminthic and undernutrition remedies in SSA, 2) document their bio-efficiency, mode of action, safety, and optimal application conditions and 3) highlight priority areas for further research.
MATERIALS AND METHODS : A PRISMA approach-based search of literature from the past three decades was performed in several electronic academic research databases and accredited scholarly repositories.
RESULTS : The review identified 15 iENPs from 88 scientific articles. The Vachellia and Vernonia species possessing polyphenols, saponins and essential oils as the dominant phytochemicals demonstrated the highest anthelminthic and nutritional potency. However, for most iENPs, nutrients and phytochemicals have not been fully profiled, optimal conditions of application are not yet ascertained, bio-efficiency is highly variable, mode of action remains unclear, and safety limits are unknown.
CONCLUSION : To exploit the full potential of SSA's iENPs as anthelminthic and undernutrition remedies for ruminants, the review advocates for a holistic, transdisciplinary regional approach focusing on identifying key phytochemicals in indigenous plants, validating their bio-efficacy and mechanisms of action, determining safety limits, and optimizing application conditions using least-cost technologies.
Geslagsregister van die familie Swart in Suid-Afrika
(Raad vir Geesteswetenskaplike navorsing, Pretoria, 1977) de Villiers, C. G. S.; Endemann, L. C. P.
Die redigering van Die geslagsregister van die familie Swart in Suid-Afrika is gedurende Maart 1975 aan my opgedra en vir bykans twee jaar daarna was die manuskrip my daaglikse metgesel. Die redigering daarvan was geen maklike taak nie: afgesien van die omvang van die werk het die tipies persoonlike aanslag van die outeur hoë eise gestel aan redigering. Daar is deurgaans probeer om so veel as moontlik van hierdie persoonlike kleur te behou.
The experiences of middle managers enacting strategic roles in financial services organisations in South Africa
(University of Pretoria, 2025-03-04) Meyerowitz, Danielle; ichelp@gibs.co.za; Gumede, Gugulani Pearl
For organisations to remain competitive in uncertain turbulent markets, growing
research on emergent strategic approached calls for business leaders to open up
strategy formulations processes and include actors outside the corporate elites, such
as middle managers, in so called open strategy processes (Brielmaier & Friesl,
2023). This to afford them the unique insights and perspectives to guide strategy
formulation for strategic agility.
However, there is limited knowledge about the practical applications of such
approaches beyond theory (Brielmaier & Friesl, 2023), and less about the middle
managers perspectives when invited to join open strategy processes notwithstanding
the dynamics of their interactions with senior leadership (Rouleau & Balogun, 2011;
Splitter et al., 2023)
This cross-sectional interpretivist study employs exploratory qualitative research
methods to explore the experiences of middle managers in organisation’s strategy
formulation processes. Data was gathered from 14 semis-structured interviews with
middle managers from the financial services sector in South Africa and thematically
analysed to gain their unique lived experiences.
Findings indicated that the majority of middle managers were being included in
strategy formulation with positive experiences of inclusion, however a new
perspective were the negative consequences of inclusion that impaired their ability
to effectively participate.
These findings have important significant for business leaders adopting open
strategy process as they provide pertinent insights that can guide the preparation of
middle managers for inclusion in strategy formulation. In addition, this research
addresses the call for research that gives light on the dynamic of interdiscursive
interactions between senior leaders and middle managers from the middle managers
unique perspective.