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About
In this study we are testing a new vaccine against Respiratory Syncytial Virus (RSV).
This virus can cause respiratory infections such as bronchiolitis and pneumonia. It affects all ages, but especially infants, adults with a suppressed immune system, and the elderly. RSV only infects humans and occurs in epidemics each winter. It is the single most common cause of severe respiratory illness in children.
There is no effective anti-viral medication to treat RSV infections. There is a monoclonal antibody, which can be given to 'at-risk' children given by injection on a monthly basis during winter to provide short term protection against infection, but it is only partially effective and prohibitively expensive. Currently, there is no licensed vaccine to prevent RSV infection and there remains a real need to develop a vaccine as a cost-effective method to save lives and reduce the cost of disease caused by RSV.
Full description
We are testing two new RSV vaccines, given in different combinations and by different routes of administration. Each vaccine uses the same RSV proteins to stimulate immune responses. These proteins are the F (Fusion), N (Nucleocapsid) and M2-1 (Matrix) proteins. The F protein sits on the surface of the virus and is needed to infect human cells. Antibodies to this protein are an important mechanism to prevent infection. The N and M2-1 proteins are needed for viral replication and are targets of immune recognition.
The two vaccines in this study contain all three of these proteins. However, they are delivered into the body using different 'vectors', which are harmless carrier viruses. In this study, we have employed two different vectors:a simian adenoviruses (PanAd3) and Modified Vaccinia virus Ankara (MVA).
We administer these vaccines using a 'prime-boost' strategy, in which one of these vaccines is used to 'prime' the immune system, which is then 'boosted' 4 or 8 weeks later, depending on the groups, by administration of an alternative vaccine or the same vaccine given by a different route.
Enrollment
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Volunteers
Inclusion criteria
Participants must satisfy all of the following criteria to be considered eligible for the study:
Willing and able to give informed consent for participation in the study
Aged between 18 and 50 years (Groups 1-4) or aged 60-75 years (Groups 5-9)
In good health as determined by
Willing to use effective contraception
Able to attend the scheduled visits and to comply with all study procedures
Willing to allow his or her General Practitioner and/or Consultant, if appropriate, to be notified of participation in the study
Confirmation from GP that they are aware of the inclusion and exclusion criteria and are satisfied from their knowledge of the volunteer that they are suitable to enroll
Willing to provide their National Insurance/Passport number for the purpose of TOPS registration
Exclusion criteria
The participant may not enter the study if any of the following apply:
History of significant organ/system disease that could interfere with trial conduct or completion. This includes any history of significant disease in the following;
Have any known or suspected impairment or alteration of immune function, resulting from, for example:
A vaccination history indicative of;
Detection of any of the following at screening
Known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)
Nasal septal pathology including
Scheduled procedures requiring general anaesthesia during the study
Participation in another research study involving an investigational product in the past 12 weeks, or are planning to do so within the 20 weeks of this study
Inability, in the opinion of the Investigator, to comply with all study requirements
Female participants who are pregnant, lactating or planning pregnancy during the course of the study
Has donated blood within 4 months before starting the trial, or is intending to donate blood during the trial and up to 12 weeks after completing the study
Any other significant disease or disorder which, in the opinion of the Investigator, may
Primary purpose
Allocation
Interventional model
Masking
72 participants in 9 patient groups
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Data sourced from clinicaltrials.gov
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