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Safety and protective efficacy of BCG vaccination against controlled human malaria infection

The primary objective is to determine the safety and tolerability BCG vaccination followed by controlled human malaria infection; and to determine the protective efficacy BCG vaccination against a controlled human malaria infection.

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.

Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model for the evaluation of transmission-blocking interventions

Primary objectives:1) To evaluate the safety of four different CHMI-trans protocols in healthy malaria-naïve volunteers challenged with Plasmodium falciparum by sporozoite challenge. 2) To determine the best CHMI-trans protocol for induction of…

Pilot study: Fosfomycin levels in prostate tissue after oral and iv administration

To measure intraprostatic concentrations and serum levels of fosfomycine after a single oral or intravenous dose prior to TURP. This is done to achieve more insight in whether fosfomycin is a suitable antibiotic to use as profylaxis or treatment of…

Immunogenicity and safety of an adjuvant hepatitis B vaccine (fendrix) compared to Engerix in non-responding HIV-infected patients

To study the immunogenicity and safety of adjuvanrt hepatitis B vaccin (Fendrix) compared to double-dosage of Engerix vaccination in HIV infected patients, previously failing HBV vaccinations.

An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals' candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older.

The purpose of this long-term follow-up (LTFU) study (ZOSTER-024) is to evaluate the cell-mediated and humoral immune responses of subjects who previously participated in study ZOSTER-003 and who were in the group receiving 2 doses of 50µg gE/AS01B…

Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD).

Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…

A two-part, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety and causal prophylactic efficacy of KAF156 in a controlled human malaria challenge model

This is a two part proof of efficacy study of KAF156 as a causal prophylactic agent in malaria. Results will be used to guide dose selection for further development of KAF156 in patients.

The effects of BCG-vaccination on the immune response induced by influenza-vaccination in healthy volunteers. A pilot proof-of-principle study.

Primary objective: The primary objective of the study is to determine the effects of BCG-vaccination on the immune response induced by subsequent influenza vaccination in healthy volunteers. This will be determined by measuring the Th1/Th2 response…

The adenosine receptor; a new pharmacological tool in the treatment of sepsis.

Does antagonism of the adenosine receptor by caffeine lead to an increased LPS-induced inflammatory reaction and an increase in (subclinical) tissuedamage?Does the C34T-polymorphism of the enzyme AMP-deaminase lead to a decreased inflammatory…

Pre-emptive tocilizumab in hypoxic COVID-19 patients, a prospective randomized trial

The aim of the study is to assess whether early administration of the drug tocilizumab in SARS-CoV-2 infection (COVID19 - coronavirus) can prevent the risk of death and mechanical ventilation (assisted respiration by a ventilator).

A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)

To assess the safety and reactogenicity of HB-101.To assess the immunogenicity of HB-101.

Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers

Primary objective - to describe immunogenicity and safety in healthy volunteers of the intradermal dermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with…

Anti-COVID19 VaccinaTion AKS-452X BOOSTER Study (ACT-BOOSTER study)

Hypothesis: A booster dose of the naked (i.e. non-adjuvanted) 5x concentrated AKS-452X vaccine, will provide an enhanced immune response after vaccination with any of the registered vaccines, either as primary vaccin or booster vaccin, against COVID…

Establishing the safety, tolerability and immunogenicity of intradermal delivery of mRNA SARS-CoV-2 vaccine in healthy adults

Primary objectives:- to describe tolerability, safety and immunogenicity in healthy adults of the intradermal delivery of one or two fractional doses of 10 µg and 20 µg mRNA-1273 LPN vaccine (Moderna).- to compare the immunogenicity in healthy…

Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study (ACT-Study)

Objective: Evaluation of safety and initial efficacy of a novel fusion-protein based anti-COVID19 vaccine in healthy volunteers.

A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of
Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55
Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive

The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and…

Alkaline phosphatase for reducing systemic inflammatory response syndrome (SIRS) in patients with Sars-CoV-2 infection and acute respiratory insufficiency (COVID 19)

To assess the preliminary efficacy of AP in reducing the inflammatory reaction in COVID-19 patients and thereby shorten time on mechanical ventilation or prevent the need for mechanical ventilation in COVID-19 patients.

Effect of intranasal administration of palivizumab on experimental respiratory syncytial viral infection - a controlled human infection study

Study A: Validation of productive infection of RSV CHIMStudy B: Effectiveness and immunogenicity of local administration of palivizumab on prevention of experimental RSV infection

Study A: A placebo-controlled crossover study to assess safety of intranasal administration of palivizumab
Study B: Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection - a double-blind randomized controlled trial

Study A: Safety of intranasal administration of palivizumab in healthy adultsStudy B: Effect of local administration of palivizumab on prevention of RSV infection