RSV001 - A New Vaccine to Prevent Severe Viral Chest Infections.
A Phase I Study to Assess Safety and Immunogenicity of a New Respiratory Syncytial Virus (RSV) Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Simian Adenovirus (PanAd3-RSV) and Modified Vaccinia Virus Ankara (MVA-RSV)
2 other identifiers
interventional
72
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2013
CompletedFirst Posted
Study publicly available on registry
March 6, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedApril 26, 2016
April 1, 2016
2.3 years
March 5, 2013
April 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
The recording and assessment of local and systemic adverse events following administration of each vaccine dose; * Fever * Headache * Nausea and/or vomiting * Malaise * Myalgia * Arthralgia * Injection site adverse events (for IM administered vaccine); pain or tenderness, induration, redness and swelling * Nasal site adverse events (for IN administered vaccine); pain or tenderness, irritation and discharge * Blood parameters * Any unsolicited symptom(s) not listed above
52 Weeks
Secondary Outcomes (1)
Immunogenicity
52 weeks
Study Arms (9)
Arm 1. Prime PanAd3-RSV (IM), boost MVA-RSV (IM)
EXPERIMENTALGroup 1A. Low dose prime PanAd3-RSV given by intra-muscular injection (IM) - low dose boost MVA-RSV given by intra-muscular injection (IM). 2 volunteers, 18-50 years. Interval: 8 weeks. Group 1B. High dose prime PanAd3-RSV given by intra-muscular injection (IM) - high dose boost MVA-RSV given by intra-muscular injection (IM). 8 volunteers, 18-50 years. Interval: 8 weeks.
Arm 2. Prime PanAd3-RSV (IM), boost PanAd3-RSV (IM)
EXPERIMENTALGroup 2A. Low dose prime PanAd3-RSV given by intra-muscular injection (IM) - low dose boost PanAd3-RSV given by intra-muscular injection (IM). 2 volunteers, 18-50 years. Interval: 4 weeks. Group 2B. High dose prime PanAd3-RSV given by intra-muscular injection (IM) - high dose boost PanAd3-RSV given by intra-muscular injection (IM). 8 volunteers, 18-50 years. Interval: 4 weeks.
Arm 3. Prime PanAd3-RSV (IN), boost MVA-RSV (IM)
EXPERIMENTALGroup 3A. Low dose prime PanAd3-RSV given intra-nasally (IN) - low dose boost MVA-RSV given by intra-muscular injection (IM). 2 volunteers, 18-50 years. Interval: 8 weeks. Group 3B. High dose prime PanAd3-RSV given intra-nasally (IN) - high dose boost MVA-RSV given by intra-muscular injection (IM). 8 volunteers, 18-50 years. Interval: 8 weeks.
Arm 4. Prime PanAd3-RSV (IN), boost PanAd3-RSV (IM)
EXPERIMENTALGroup 4A. Low dose prime PanAd3-RSV given intra-nasally (IN) - low dose boost PanAd3-RSV given by intra-muscular injection (IM). 2 volunteers, 18-50 years. Interval: 8 weeks. Group 4B. High dose prime PanAd3-RSV given intra-nasally (IN) - high dose boost PanAd3-RSV given by intra-muscular injection (IM). 8 volunteers, 18-50 years. Interval: 8 weeks.
Arm 5. No vaccine
NO INTERVENTIONGroup 5. Non-vaccinated control group. 6 volunteers, 60-75 years.
Arm 6. MVA-RSV (IM)
EXPERIMENTALGroup 6. Single high dose MVA-RSV given by intra-muscular injection (IM). 6 volunteers, 60-75 years.
Arm 7. Prime PanAd3-RSV (IM), boost PanAd3-RSV (IM)
EXPERIMENTALGroup 7. High dose prime PanAd3-RSV given by intra-muscular injection (IM) - high dose boost PanAd3-RSV given by intra-muscular injection (IM). 6 volunteers, 60-75 years. Interval: 4 weeks.
Arm 8. Prime PanAd3-RSV (IN), boost MVA-RSV (IM)
EXPERIMENTALGroup 8. High dose prime PanAd3-RSV given intra-nasally - high dose boost MVA-RSV given by intra-muscular injection (IM). 6 volunteers, 60-75 years. Interval: 8 weeks.
Arm 9. Prime PanAd3-RSV (IM), boost MVA-RSV (IM)
EXPERIMENTALGroup 9. High dose prime PanAd3-RSV given by intra-muscular injection (IM) - high dose boost MVA-RSV given by intra-muscular injection (IM). 6 volunteers, 60-75 years. Interval: 8 weeks.
Interventions
High dose = 5x10\^10 vp
High dose = 1x10\^8 pfu
High dose = 5x10\^10 vp
Low dose = 5x10\^9 vp
Low dose = 1x10\^7 pfu
Low dose = 5x10\^9 vp
Eligibility Criteria
You may qualify if:
- 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
- Medical history
- Physical examination
- Clinical judgment of the investigators
- Willing to use effective contraception
- Females: The oral contraceptive pill, contraceptive implant or barrier methods from one month prior and for the duration of the study (Groups 1-4 only)
- Males: Barrier contraception from V1 until 3 months after the last vaccination
- 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
You may not qualify if:
- Willing to provide their National Insurance/Passport number for the purpose of TOPS registration
- 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;
- Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death
- Respiratory disease such as asthma (excluding childhood asthma not treated in adulthood) and chronic obstructive pulmonary disease
- Endocrine disorders such as diabetes mellitus and Addison's disease
- Significant renal or bladder disease, including history of renal calculi
- Biliary tract disease
- Gastro-intestinal disease such as inflammatory bowel disease, abdominal surgery within the last two years, coeliac disease and liver disease
- Neurological disease such as seizures and myasthenia gravis
- Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency
- Psychiatric illness requiring hospitalization or depression whose severity is deemed clinical significant by the Chief Investigator, Consultant or GP
- Non-benign cancer, including squamous cell carcinoma, basal cell carcinoma of the skin and cervical carcinoma in situ
- Clinically significant contact dermatitis
- Have any known or suspected impairment or alteration of immune function, resulting from, for example:
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ReiThera Srllead
Study Sites (1)
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Related Publications (2)
Green CA, Scarselli E, Voysey M, Capone S, Vitelli A, Nicosia A, Cortese R, Thompson AJ, Sande CS, de Lara C, Klenerman P, Pollard AJ. Safety and immunogenicity of novel respiratory syncytial virus (RSV) vaccines based on the RSV viral proteins F, N and M2-1 encoded by simian adenovirus (PanAd3-RSV) and MVA (MVA-RSV); protocol for an open-label, dose-escalation, single-centre, phase 1 clinical trial in healthy adults. BMJ Open. 2015 Oct 28;5(10):e008748. doi: 10.1136/bmjopen-2015-008748.
PMID: 26510727DERIVEDGreen CA, Scarselli E, Sande CJ, Thompson AJ, de Lara CM, Taylor KS, Haworth K, Del Sorbo M, Angus B, Siani L, Di Marco S, Traboni C, Folgori A, Colloca S, Capone S, Vitelli A, Cortese R, Klenerman P, Nicosia A, Pollard AJ. Chimpanzee adenovirus- and MVA-vectored respiratory syncytial virus vaccine is safe and immunogenic in adults. Sci Transl Med. 2015 Aug 12;7(300):300ra126. doi: 10.1126/scitranslmed.aac5745.
PMID: 26268313DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J Pollard, FRCPCH PhD
University of Oxford. Department of Paediatrics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2013
First Posted
March 6, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
April 26, 2016
Record last verified: 2016-04