We conducted a Phase 1b study to evaluate the immunogenicity and safety of two live attenuated tetravalent dengue vaccines in healthy adult volunteers. After one injection, all subjects reported systemic reactions consistent with a mild dengue-like syndrome. Seven volunteers developed dengue 3 viraemia after vaccination. All subjects developed a neutralizing antibody response against serotype 3 with partial response against other serotypes. The trial was stopped early (after 10 subjects enrolled) due to formulation issues, which were related to the dengue 3 vaccine component. Managing viral interference and balancing attenuation to produce acceptable tetravalent immunogenicity with minimal reactogenicity may be a recurring problem for future multivalent live vaccines.
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http://dx.doi.org/10.1016/j.vaccine.2005.09.029 | DOI Listing |
JAMA Ophthalmol
January 2025
Xiamen Eye Center of Xiamen University, Xiamen, Fujian, China.
Importance: Bietti crystalline dystrophy (BCD) is a severe genetic retinopathy caused by variants in the CYP4V2 gene. Currently, there is no approved treatment for BCD.
Objective: To evaluate safety and vision outcomes following gene therapy with adeno-associated virus (AAV) encoding CYP4V2 (rAAV-hCYP4V2, NGGT001 [Next Generation Gene Therapeutics]).
Alzheimers Dement
December 2024
Alzheimer's Therapeutic Research Institute, San Diego, CA, USA.
Background: Major advances have been made over the past decade in understanding Down syndrome-related AD by utilizing the latest AD biomarkers such as brain imaging and biofluid assays. Cognitive measures that can discern decline related to AD have been developed and validated in people with DS. We are now able to incorporate these data to help design clinical trials against AD in people with DS.
View Article and Find Full Text PDFAllergy
January 2025
St John's Institute of Dermatology, Guy's Hospital, London, UK.
Background: This study compared the therapeutic equivalence of CT-P39 (an omalizumab biosimilar) and EU-approved reference omalizumab (ref-OMA) in patients with chronic spontaneous urticaria.
Methods: This double-blind, randomized, active-controlled Phase 3 study (NCT04426890) included two 12-week treatment periods (TPs). In TP1, patients received CT-P39 300 mg, ref-OMA 300 mg, CT-P39 150 mg, or ref-OMA 150 mg.
Background: Amylin is a systemic hormone that is co-secreted with insulin from pancreatic β-cells. Amylin co-aggregates with brain parenchymal and vascular β-amyloid in persons with Alzheimer's dementia. The present pilot study sought to assess the safety and side effects during and after the treatment period of passive amylin immunotherapy in the APP/PS1 mouse model of Alzheimer's disease.
View Article and Find Full Text PDFBackground: ALZ-101 is a vaccine comprised of stabilised oligomeric Aβ42 that stimulates a humoral immune response primarily targeting a toxic, low-abundant oligomeric form of Aβ. Part A of a clinical Phase 1b trial (ALZ-C-001; NCT05328115) was recently concluded with the objectives to assess the safety, tolerability and immunogenicity of ALZ-101 in subjects with mild AD or MCI due to AD.
Methods: Participants were randomised to receive placebo (n = 6), 125 µg (n = 10) or 250 µg (n = 10) doses of ALZ-101 at weeks 0, 4, 8, and 16.
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