4 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: * Are between the age of 18 to 49 years old. * Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Are healthy as determined by medical history, physical examinations, and the study doctor. * For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children. * Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.
Study Design: This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost, two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1 boost but with different boost intervals, and one group will receive the DNA vaccine twice as prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human administration and will elicit antibody and T cell responses against the H5 protein. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the study vaccine regimens. Product Description: The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade 2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90 microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1 vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System (Biojector) for the DNA vaccine. Subjects: A total of 60 healthy adults, ages 18-60 years will be enrolled. Study Plan: Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups. Subjects and clinicians will be blinded to group assignment until Day 0 following completion of the enrollment. At the point of enrollment the randomly assigned regimen will become known to subjects and clinicians. Subjects will receive either two or three injections on the schedule shown in the schema. The protocol requires five clinic visits and two telephone follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone follow-up contacts for Group 4.
The aim of this study is to determine whether receiving a core letter signed by the Surgeon General or the Director of the National Vaccine Program that provides only information about influenza, or a core letter signed by the Surgeon General with an added basic or enhanced implementation prompt, will increase rates of influenza vaccination among Medicare beneficiaries when compared to a control group.