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Effects of BCG vaccination on immunological characteristics of hematopoetic stem cells: an explorative study

To examine the effect of BCG vaccination on the composition and function of the bone marrow.

A randomized double-blind placebo-controlled phase 1 study regarding safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM 8101) in healthy male subjects.

To assess the safety, tolerability and pharmacokinetic/-dynamic response, of single escalating doses of ADRECIZUMAB (0.5 mg/kg, 2mg/kg and 8 mg/kg administered as single infusion over 1 hour) in healthy male subjects.

Laser therapy for onychomycosis in patients with diabetes at risk for diabetic foot complications
A randomized, double blind controlled trial.

To determine the efficacy and safety of laser therapy in diabetes patients with risk factors for developing diabetic foot complications.

APA12/PANTER* study: ""PTM202 and modulation of host resistance to diarrheagenic Escherichia coli in a randomized placebo-controlled trial in healthy human subjects"

To study whether PTM202, a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg, improves the resistance of humans to traveller*s diarrhea as caused by diarrheagenic E. coli. PTM202 contains specific…

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…

Quadrivalent HPV vaccination after effective treatment of Anal Intraepithelial Neoplasia in HIV+ men (VACCAIN-P)

The primary objective of the current study is to assess the efficacy of qHPV vaccination in preventing recurrence of high-grade AIN in HIV+ MSM with CD4 counts >350 x 10E6/l who were successfully treated for high-grade intra-anal AIN in the…

A PHASE 2 RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF MHAA4549A,
A MONOCLONAL ANTIBODY, IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR
TREATMENT OF SEVERE INFLUENZA A INFECTION

2. OBJECTIVES2.1 SAFETY OBJECTIVESThe safety objectives for this study are as follows:* To evaluate the safety of MHAA4549A in combination with oseltamivir compared with placebo and oseltamivir in patients with severe influenza A, focusing on the…

A Phase II, global, randomized study to evaluate the efficacy and safety of Danirixin (GSK1325756) co-administered with a standard-of-care antiviral (oseltamivir), in the treatment of adults hospitalized with influenza (study 201023, DAHLIA)

Primary:To assess the efficacy of treatment with IV danirixin twice daily given with oral oseltamivir compared to oral oseltamivir twice daily on time to clinical response (TTCR)Secondary:Time to respiratory response (TTRR), clinical measures of…

A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection

Primary ObjectivesThe primary objectives are to evaluate in infants who are hospitalized with RSV infection:• the pharmacokinetics of JNJ-53718678 after multiple oral doses;• the safety and tolerability of JNJ-53718678 when administered for 7 days.…

A randomised, double-blind, placebo-controlled, single-centre phase IIb trial as part of the EU-funded UNISEC project to assess the immunogenicity and safety of different formulations and dosing regimens of FLU-v vaccine administered subcutaneously in healthy adults aged 18-60 years.

To investigate the safety of the vaccination and the immune responses generated by the different formulations and dosing regimens of FLU-v in healthy adults.

The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia

Primary objective:­To determine whether endotoxin tolerance can be prevented by acetylsalicylic acid prophylaxis or can be reversed by acetylsalicylic acid treatment, expressed as an augmentation of pro-inflammatory cytokine levels during the second…

A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.

A Phase 2b, Randomized, Controlled Trial Evaluating GS 5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is as follows:* To evaluate the effect of presatovir (GS-5806) on nasal RSV viral load in RSV positive LT recipients with acute respiratory symptomsThe secondary objectives of this study are as follows: * To…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled
Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effects ofpresatovir (GS-5806) on RSV viral load in RSV-positive adults hospitalizedwith acute respiratory infectious symptoms.The secondary objectives of this study are to evaluate:- The effect…

Human Exposure to RhinOvirus * Effect of a plant-based polysaccharide food supplement on upper respiratory symptoms

This study is designed to test if consumption of a vegetable extract as a food ingredient improves resistance to an experimental respiratory tract infection with RV16 in healthy volunteers.Primary Objective: * To test and quantify the effect of the…

A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteers

Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study and an Open-Label Relative Bioavailability and Food Effect Study of VX-787 in Healthy Subjects

Primary: Part A:to evaluate the safety and tolerability of single oral ascending doses of VX-787 administered to healthy male and female subjects (of non-childbearing potential)Part C:to evaluate safety and tolerability of multiple oral ascending…

The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.

In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects with Uncomplicated Influenza.

Primary ObjectiveTo evaluate the clinical efficacy of favipiravir compared with placebo in treating adult subjects who have confirmed influenza.Secondary Objectives- To further evaluate the clinical and anti-viral effects of favipiravir.- To…

The effect of Staphefekt on the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis.

To retrieve (in vivo) data about the effect of Staphefekt on the microbiome, including Staphylococcus aureus, and on disease severity in patients with atopic dermatitis.