相关临床试验
4
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2017
进行中（未招募）
1
25.0%
已完成
3
75.0%
暂无批准数据
- DelveInsight's 2025 pipeline report identifies 7+ companies developing novel Lyme disease therapies, with emerging treatments including BLB 400, FP-100, CT38, TP-05, and VLA15 expected to significantly impact the market. - Valneva and Pfizer reported positive Phase II booster results for their Lyme disease vaccine candidate VLA15 in September 2024, following completion of the primary vaccination series for their Phase III VALOR trial in July 2024. - Tarsus Pharmaceuticals announced encouraging results from their Phase IIa "Tick-Kill" trial of TP-05 (lotilaner) for Lyme disease prevention in February 2024. - The pipeline spans multiple development stages from preclinical to Phase III, with various routes of administration including oral, parenteral, intravenous, subcutaneous, and topical formulations.
- Blue Lake Biotechnology and CyanVac published full Phase 1 data in Science Advances showing their intranasal COVID-19 vaccine candidate CVXGA demonstrated safety and immunogenicity in 72 healthy subjects aged 12-51 years. - The single-dose PIV5-vectored vaccine achieved 92% CD8+ T cell response rates in low-dose groups and 89% in high-dose groups, with 31-41% of high-dose participants developing three-fold increases in mucosal antibodies. - High-dose CVXGA1 showed 67.8% relative vaccine effectiveness against symptomatic COVID-19 infection at 7.3 months post-vaccination compared to low-dose recipients (p=0.048). - The vaccine stimulated all three pillars of immunity—humoral, cellular, and mucosal—with minimal reactogenicity and no serious adverse events related to vaccination.
- CyanVac's CVXGA nasal COVID-19 vaccine demonstrated a 67% reduction in infection risk compared to unvaccinated individuals in the first US-based phase 1 clinical trial. - The single-dose vaccine generated both mucosal and systemic immune responses, with higher dose groups showing infection rates of 11.1% to 22.2% compared to 73.3% in the low-dose control group. - Results published in Science Advances have prompted two larger clinical trials, including one enrolling up to 10,016 participants by mid-2026. - The nasal delivery approach aims to block SARS-CoV-2 at its mucosal entry site and could join four other nasal COVID vaccines already approved internationally.
- CyanVac's CVXGA, an intranasal COVID-19 vaccine, has dosed its first participant in a Phase 2b clinical study. - The trial, supported by Project NextGen, will compare CVXGA to an FDA-approved mRNA vaccine targeting the Omicron KP.2 variant. - Approximately 10,000 adults will be enrolled, with initial safety data reviewed before broader enrollment proceeds. - The study will assess CVXGA's efficacy in preventing symptomatic and asymptomatic SARS-CoV-2 infections over 12 months.
- Blue Lake and CyanVac reported positive Phase 2a clinical trial data for their intranasal COVID-19 vaccine candidate, CVXGA, demonstrating safety and efficacy. - The trial showed a 78% reduction in the risk of symptomatic COVID-19 infection in participants who received CVXGA compared to the placebo group. - CVXGA induced S-protein specific serum antibody responses in both younger (18-64 years) and older adults (65+ years), with good tolerability. - The PIV5-vectored vaccine showed no significant difference in adverse reactions compared to placebo, suggesting a safe and well-tolerated profile.
- Blue Lake Biotechnology and CyanVac presented positive interim Phase 1/2a data for BLB201, an intranasal vaccine candidate against respiratory syncytial virus (RSV), in RSV-seropositive children. - Phase 1 data for CVXGA, the companies’ intranasal vaccine candidate against COVID-19, demonstrated systemic and mucosal antibody responses and T cell-mediated responses. - Preclinical data on a PIV5-based vaccine for Lyme disease, a collaboration with Immuno Technologies, showed protection against multi-strain _Borrelia burgdorferi_ in mice.
