Randomized, Doubleblind, Placebo-controlled Trial in Healthy Adults of Safety and Immunogenicity of 2 Intranasal Doses of SynGEM®, an RSV Candidate Vaccine Containing F Glycoprotein Linked to a Bacterium-like-Particle (BLP) Carrier

The study is a double-blind (within dose level), placebo-controlled Phase I study to assess the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs), each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day 29. The two dose levels will be recruited sequentially.
Immunogenicity end-points will include assessment of humoral and cellular responses at selected time-points.

开始日期2016-10-01

申办/合作机构

Mucosis BV

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100 项与 Intranasal respiratory syncytial virus vaccine (Virtuvax) 相关的临床结果

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100 项与 Intranasal respiratory syncytial virus vaccine (Virtuvax) 相关的转化医学

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100 项与 Intranasal respiratory syncytial virus vaccine (Virtuvax) 相关的专利（医药）

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项与 Intranasal respiratory syncytial virus vaccine (Virtuvax) 相关的文献（医药）

2020-12-01·BMC Veterinary Research2区 · 农林科学

Field trial to evaluate the effect of an intranasal respiratory vaccine protocol on bovine respiratory disease incidence and growth in a commercial calf rearing unit

2区 · 农林科学

ArticleOA

作者: Soveri, Timo ; Simojoki, Heli ; Sandelin, Atte ; Seppä-Lassila, Leena ; Härtel, Heidi ; Rautala, Helena ; Kaartinen, Liisa

AbstractBackgroundBovine respiratory disease (BRD) continues to be great challenge in calf rearing units. The urgent need to decrease the use of antibiotics and increase animal welfare in beef production has forced us to introduce new preventive methods. Vaccinations could contribute to the solution, but the high incidence of BRD already at an early age has made it difficult to introduce suitable vaccination programs. Challenge studies have shown promising results in 3–14 day old calves vaccinated with intranasal BRD vaccine, but very few field trials are available to assess the efficacy of the intranasal vaccines in field conditions. We evaluated the effect of one dose of commercial intranasal vaccination on calf mortality, daily gain, and treatment incidence for BRD in one calf rearing unit. In total, 497 calves (mean age 19 days) were included in our study, 247 of which were vaccinated at the time of arrival to the unit and 250 served as negative controls (unvaccinated). Vaccinated and unvaccinated calves were situated in separate compartments until weaning. Daily gain, treatment incidence, and mortality were recorded until the calves were transported to the finishing unit, which averaged 154.5 days from arrival.ResultsAverage daily gain over the complete study period was 1151.9 g/day (SD 137.9) for the vaccinated calves and 1139.5 g/day (SD 135.9) for the unvaccinated calves. Intranasal vaccination combined with older arrival age (17 days or older) resulted in a higher daily gain (47.8 g/day) compared with unvaccinated calves (coef. 0.0478, p = 0.003). This association was not recorded in calves that were younger than 17 days upon arrival. Intranasal vaccination was not significantly associated either with mortality (OR 0.976, p = 0.968) or treatment incidence for BRD (OR 1.341, p = 0.120). In total, six vaccinated calves (2.43%) and six unvaccinated calves (2.40%) died during the study period.ConclusionsVaccinating arriving calves with intranasal vaccine in the calf rearing unit did not decrease the mortality or treatment incidence for BRD, but it significantly improved the weight gain in calves transported to the unit at the age of 17 days or older.

2019-08-15·American Journal of Respiratory and Critical Care Medicine1区 · 医学

Local and Systemic Immunity against Respiratory Syncytial Virus Induced by a Novel Intranasal Vaccine. A Randomized, Double-Blind, Placebo-controlled Clinical Trial

1区 · 医学

Article

作者: Grimaldi, Roberto ; Ahmed, Muhammad S. ; Leenhouts, Kees ; Kalyan, Mohini ; Wallin-Weber, Sanna ; Ascough, Stephanie ; Dijkstra-Tiekstra, Margriet ; Openshaw, Peter J. ; Zhang, Qibo ; Chiu, Christopher ; Haijema, Bert-Jan ; Vlachantoni, Iris ; van Roosmalen, Maarten

Rationale: Needle-free intranasal vaccines offer major potential advantages, especially against pathogens entering via mucosal surfaces. As yet, there is no effective vaccine against respiratory syncytial virus (RSV), a ubiquitous pathogen of global importance that preferentially infects respiratory epithelial cells; new strategies are urgently required.Objectives: Here, we report the safety and immunogenicity of a novel mucosal RSV F protein vaccine linked to an immunostimulatory bacterium-like particle (BLP).Methods: In this phase I, randomized, double-blind, placebo-controlled trial, 48 healthy volunteers, aged 18-49 years, were randomly assigned to receive placebo or SynGEM (low or high dose) intranasally by prime-boost administration. The primary outcome was safety and tolerability, with secondary objectives assessing virus-specific immunogenicity.Measurements and Main Results: There were no significant differences in adverse events between placebo and vaccinated groups. SynGEM induced systemic plasmablast responses and significant, durable increases in RSV-specific serum antibody in healthy, seropositive adults. Volunteers given low-dose SynGEM (140 μg F, 2 mg BLP) required a boost at Day 28 to achieve plateau responses with a maximum fold change of 2.4, whereas high-dose recipients (350 μg F, 5 mg BLP) achieved plateau responses with a fold change of 1.5 after first vaccination that remained elevated up to 180 days after vaccination, irrespective of further boosting. Palivizumab-like antibodies were consistently induced, but F protein site ∅-specific antibodies were not detected, and virus-specific nasal IgA responses were heterogeneous, with the strongest responses in individuals with lower pre-existing antibody levels.Conclusions: SynGEM is thus the first nonreplicating intranasal RSV subunit vaccine to induce persistent antibody responses in human volunteers.Clinical trials registered with www.clinicaltrials.gov (NCT02958540).

2018-09-01·Journal of Dairy Science1区 · 农林科学

Field trial to evaluate the effect of an intranasal respiratory vaccine protocol on calf health, ultrasonographic lung consolidation, and growth in Holstein dairy calves

1区 · 农林科学

Article

作者: Kelton, D F ; Nydam, D V ; Hewson, J ; Duffield, T F ; Caswell, J ; Leslie, K E ; Ollivett, T L ; Dunn, P

The objective of this field trial was to evaluate the effect of a vaccine protocol using a commercially available trivalent vaccine designed for intranasal use. Experimental challenge studies have demonstrated varying efficacies of vaccines administered via the intranasal route. A total of 468 calves from 3 herds were enrolled and randomized into 3 treatment groups (positive control, PC, n = 211; intranasal vaccine, IN, n = 215; negative control, NC, n = 42) and followed for 8 to 12 wk. The PC consisted of one dose of commercially available multivalent injectable vaccine against bovine respiratory syncytial virus, infectious bovine rhinotracheitis, parainfluenza 3, and bovine viral diarrhea administered subcutaneously at 6 wk of age. The IN was administered at enrollment and 6 wk of age, and contained antigen against bovine respiratory syncytial virus, infectious bovine rhinotracheitis, and parainfluenza 3. The NC was sterile saline administered intranasally and subcutaneously at enrollment and 6 wk of age. Clinical illness was assessed using systematic respiratory scoring, and thoracic ultrasonography was used to identify the lung consolidation associated with pneumonia. Rib fractures were identified in 6% of calves, and an association was observed between rib fractures and calving ease. Overall, 54% of the calves had at least one episode of an abnormal respiratory score (ILL). Vaccination protocol did not affect the occurrence of ILL. Similarly, 54% of the calves had at least one episode of lung consolidation ≥3 cm (CON). Vaccine protocol affected the odds of CON. The odds of CON in PC were 1.63 (95% confidence interval: 1.04-2.56) times the odds of CON in IN, and 0.38 (95% confidence interval: 0.16-0.93) times the odds of CON in NC. The odds of CON in IN were 0.23 (95% confidence interval: 0.09-0.59) times the odds of CON in NC. The outcomes ILL and CON were associated; however, the measure of agreement was only fair (kappa = 0.38). Multivariable linear regression revealed an interaction between vaccine protocol and herd on average daily gain (ADG); therefore, these data were stratified. In herd 1, IN (0.53 ± 0.03 kg/d) decreased ADG compared with PC (0.63 ± 0.03 kg/d). In herd 2, IN increased ADG (0.41 ± 0.03 kg/d) compared with PC (0.38 ± 0.03 kg/d). In contrast, none of the protocols affected ADG at herd 3. In conclusion, this commercially available trivalent IN vaccine protocol did not alter the incidence of ILL, reduced the risk of lung lesions associated with pneumonia, and improved the ADG of the calves in one of the commercial study herds.

100 项与 Intranasal respiratory syncytial virus vaccine (Virtuvax) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
呼吸道合胞体病毒感染	临床1期	英国	Imperial College London	2016-10-01
呼吸道合胞体病毒感染	临床1期	英国	Mucosis BV	2016-10-01
毛细支气管炎	临床1期	英国	Mucosis BV	-
肺炎	临床1期	英国	Mucosis BV	-