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RNA Virus Infections clinical trials

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NCT ID: NCT02236052 Completed - Clinical trials for Respiratory Tract Infections

Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal VLP Quadrivalent Influenza Vaccine in the Elderly Population

Start date: July 16, 2014
Phase: Phase 2
Study type: Interventional

This is a multiple sites phase II trial, randomized, observer-blind, dose ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine administered in elderly subjects (50 years old and more). A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75 subjects to receive one injection of either a non-adjuvanted low, medium or high dose level of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined with Alhydrogel® as adjuvant or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80)

NCT ID: NCT02233816 Completed - Clinical trials for Respiratory Tract Infections

Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults

Start date: July 28, 2014
Phase: Phase 2
Study type: Interventional

A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to healthy adults 18-49 years of age. A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to receive one injection of either a low, a medium, or a high dose level of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).

NCT ID: NCT02022163 Completed - Clinical trials for Respiratory Tract Infections

Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.

Start date: December 2013
Phase: Phase 1
Study type: Interventional

A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy adults, 18-60 years of age.

NCT ID: NCT01991587 Completed - Clinical trials for Respiratory Tract Infections

Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults

Start date: October 8, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine administered to healthy adults 18-49 years of age. A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30 subjects to receive one injection of either a low, a medium, or a high dose level of VLP of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).

NCT ID: NCT01991561 Completed - Clinical trials for Respiratory Tract Infections

Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.

Start date: June 2013
Phase: Phase 2
Study type: Interventional

A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in healthy adults 18-60 years of age.

NCT ID: NCT01791556 Completed - HIV Infection Clinical Trials

Clinic-based ART Diagnostic Evaluation

CLADE
Start date: January 26, 2010
Phase: N/A
Study type: Interventional

The study is funded through the Office of the Global AIDS Coordinator (OGAC #KE-07-0044). The purpose of this study is two-fold. The first purpose is to see if routine monitoring of the level of HIV virus in the blood (viral load) every six months is superior to monitoring by standard clinical evaluations and or immune status (CD4 count) with intermittent viral load monitoring in adults receiving antiretroviral therapy (ART). The second purpose is to understand the cost implications and possible benefits of routine HIV viral load monitoring.

NCT ID: NCT01587131 Completed - Clinical trials for Respiratory Tract Infections

DNA-based Influenza Vaccine in the Elderly

Start date: June 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in greater immunogenicity when used to prime the immune response to a dose of a trivalent inactivated seasonal vaccine.

NCT ID: NCT01244867 Completed - Clinical trials for Respiratory Tract Infections

Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The primary objective is to assess the immunogenicity and safety and tolerability of two consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®, compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).

NCT ID: NCT00984945 Completed - Clinical trials for Respiratory Tract Infections

Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The primary objective is to assess the safety and tolerability of two consecutive doses of plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21 days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined with Alhydrogel®.