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The article discusses the establishment of a national travel medicine vaccination network in Germany to monitor the reactogenicity of the newly approved Qdenga® vaccine for dengue. Travel medicine specialists were invited to participate in the network, with 99 out of 1238 contacted specialists joining. The network collected data on vaccine tolerability and side effects, with the majority of participants finding the registration process easy and expressing willingness to participate in future activities. The platform aims to provide unbiased data on novel vaccines to facilitate their integration into clinical practice. [Extracted from the article]

Background: A study was conducted to assess the safety and tolerability of the tetravalent live-attenuated dengue vaccine Qdenga®, which received marketing approval in Germany in 2022. The study evaluated vaccine-related reactions in a predominantly dengue-naïve population, highlighting the importance of post-marketing surveillance as an essential component of safety evaluation for newly licensed vaccines., Methods: Following dengue vaccination, participants were recruited for an anonymous online questionnaire through the national 'Trav VacNet' network in Germany. The questionnaire focused on post-vaccination reactions up to 18 days after the first and second vaccination, as well as previous travel history and coadministration., Results: The study included 1176 participants, with a median age of 39 years (IQR 28-56), 53.2% female (n = 625), 46.5% male (n = 547), and 0.3% non-binary participants (n = 4). After the first dose, 51% of the participants reported systemic reactions such as headache (40% (190/474)), weakness (40% (189/474)) and malaise (32% (154/474)), which were most pronounced between days 7-11 post vaccination. After the second dose, localized signs and symptoms such as pain at the injection site (22% (n = 55/250)) were more common. Fever was more common after the first dose (20% (96/474)) vs. 2% (6/250) after the second. Females reported significantly more reactions than males after both vaccinations (1st dose p = 0.0002; 2nd dose p = 0.0003). A total of 334 (28%) co-administrations were reported whereby AEs were reported in 47% (157/333) of participants, with the highest prevalence observed when combined with the Japanese encephalitis vaccine (56.8%, (42/74)). Differences in age groups were observed, with a decrease in reactions in the elderly (≥65 years)., Conclusions: Vaccine-related reactions were frequently reported, predominantly after the first dose in dengue-naïve participants. Coadministration was a common strategy without significantly increasing side effects. The study provides important insights into reactogenicity and may help improve vaccination strategies in dengue-naïve populations., (© International Society of Travel Medicine 2025. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Next-generation COVID-19 vaccines are being developed to expand the breadth of coverage against existing and future variants and to extend the duration of protection. Prime-2-CoV_Beta is an orf virus (ORFV) based multi-antigen COVID-19 vaccine that co-expresses Spike (S) and Nucleocapsid (N) antigens. The safety and immunogenicity of Prime-2-CoV_Beta is investigated in a phase 1 first-in-human (FIH) dose-finding trial (ORFEUS study, ClinicalTrials.gov: NCT05367843). Participants of two age groups (18-55 and 65-85 years) who previously completed at least two doses of mRNA vaccines were enrolled and sequentially assigned to different dose groups to receive one intramuscular dose of 3 × 10 5 , 3 × 10 6 , 1.5 × 10 7 , or 3 × 10 7 plaque-forming units (PFU) of Prime-2-CoV_Beta on day 1 and a second dose on day 29. Here, we report safety and immunogenicity data collected up to 6 months after the first study vaccination. Prime-2-CoV_Beta is safe and well tolerated and elicits immune responses at higher dose levels in participants aged 18-55. A single dose of 3 × 10 7 PFU boosted binding and cross-neutralizing antibody responses that are maintained through 6 months after the first booster vaccination. Polyfunctional S-specific CD4+ and CD8+ T cell responses are observed after vaccination. No pre-existing or vaccine-induced neutralizing anti-vector antibodies are detected. Our findings highlight the potential of the ORFV vector as a safe platform for future vaccine design, which provides the ability to deliver multiple antigens and allows for repeat immunization.