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Respiratory Syncytial Virus InfectionsPhase 1NCT01805921

RSV001 - A New Vaccine to Prevent Severe Viral Chest Infections.

A Phase 1 study testing PanAd3-RSV given intra-nasally (high dose), MVA-RSV given by intra-muscular injection (high dose) and PanAd3-RSV given by intra-muscular injection (high dose) in people with Respiratory Syncytial Virus Infections, run by ReiThera Srl at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
PanAd3-RSV given intra-nasally (high dose), MVA-RSV given by intra-muscular injection (high dose) and PanAd3-RSV given by intra-muscular injection (high dose)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited Kingdom
Study dates
May 2013to Aug 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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
  • 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

Who cannot join

  • 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
Show all 45Show fewer
  • 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:
  • Congenital or acquired immunodeficiency
  • Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
  • Autoimmune disease
  • Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy
  • Receipt of immunoglobulin or any blood product transfusion within 3 months of study start
  • A vaccination history indicative of;
  • Planning to receive any vaccine other than the study vaccine within 4 weeks following vaccination
  • A history of anaphylaxis reaction to a vaccine
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. Kathon
  • Previously having received a recombinant simian or human adenoviral vaccine
  • Previously having received a recombinant MVA vaccine
  • Detection of any of the following at screening
  • IgA deficiency
  • Anti-HIV antibody
  • Hepatitis B surface antigen
  • Anti-HCV antibody
  • Any other significant abnormalities on screening investigations at the discretion of an Investigator
  • Known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)
  • Nasal septal pathology including
  • Congenital deformities such as an abnormal septum or polyps
  • Previous cauterization, rhinoplasty or surgery of any kind
  • Recurrent epistaxis
  • 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
  • Put the participants at risk because of participation in the study
  • Influence the result of the study
  • Impair the participant's ability to participate in the study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

About this study

Official title: 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)

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.

Read the detailed 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.

Being tested
PanAd3-RSV given intra-nasally (high dose), MVA-RSV given by intra-muscular injection (high dose), PanAd3-RSV given by intra-muscular injection (high dose), PanAd3-RSV given intranasally (low dose), MVA-RSV given by intra-muscular injection (low dose)
Keywords
Respiratory Syncytial Virus, RSV, Vaccine
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PanAd3-RSV given intra-nasally (high dose)Biological

    High dose = 5x10^10 vp

  • MVA-RSV given by intra-muscular injection (high dose)Biological

    High dose = 1x10^8 pfu

  • PanAd3-RSV given by intra-muscular injection (high dose)Biological

    High dose = 5x10^10 vp

  • PanAd3-RSV given intranasally (low dose)Biological

    Low dose = 5x10^9 vp

  • MVA-RSV given by intra-muscular injection (low dose)Biological

    Low dose = 1x10^7 pfu

  • PanAd3-RSV given by intra-muscular injection (low dose)Biological

    Low dose = 5x10^9 vp

Study groups in NCT01805921
Study groupRoleWhat they receive
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.
Receives: Biological: MVA-RSV given by intra-muscular injection (high dose); Biological: PanAd3-RSV given by intra-muscular injection (high dose); Biological: MVA-RSV given by intra-muscular injection (low dose); Biological: PanAd3-RSV given by intra-muscular injection (low dose)
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.
Receives: Biological: PanAd3-RSV given by intra-muscular injection (high dose); Biological: PanAd3-RSV given by intra-muscular injection (low dose)
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.
Receives: Biological: PanAd3-RSV given intra-nasally (high dose); Biological: MVA-RSV given by intra-muscular injection (high dose); Biological: PanAd3-RSV given intranasally (low dose); Biological: MVA-RSV given by intra-muscular injection (low dose)
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.
Receives: Biological: PanAd3-RSV given intra-nasally (high dose); Biological: PanAd3-RSV given by intra-muscular injection (high dose); Biological: PanAd3-RSV given intranasally (low dose); Biological: PanAd3-RSV given by intra-muscular injection (low dose)
Arm 5. No vaccineNo 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.
Receives: Biological: MVA-RSV given by intra-muscular injection (high dose)
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.
Receives: Biological: PanAd3-RSV given by intra-muscular injection (high dose)
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.
Receives: Biological: PanAd3-RSV given intra-nasally (high dose); Biological: MVA-RSV given by intra-muscular injection (high dose)
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.
Receives: Biological: MVA-RSV given by intra-muscular injection (high dose); Biological: PanAd3-RSV given by intra-muscular injection (high dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 52 Weeks

Secondary outcomes (1)

  1. Immunogenicity

    Immunological assays to study immune responses to each vaccine, including:

    • Serum antibody response to RSV F antigen
    • Serum antibody response capable of RSV neutralization
    • Quantification of circulating vaccine-induced B-cell secreting antibodies (IgA and IgG) against RSV F antigen
    • Quantification of circulating vaccine-induced T-cell responses against RSV antigens F, N and M2-1
    • Any further exploratory immunology to detect vaccine related immune responses

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01805921
Sponsor's protocol ID
RSV001
Other IDs
2011-003589-34
Status last verified
Apr 2016
First submitted
5 Mar 2013
Last updated
26 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26510727

  • Green 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.

    PubMed 26268313

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PanAd3-RSV given intra-nasally (high dose), MVA-RSV given by intra-muscular injection (high dose) and PanAd3-RSV given by intra-muscular injection (high dose) in people with Respiratory Syncytial Virus Infections, run by ReiThera Srl at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01805921, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.

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Clinical Trial NCT01805921 | AzTrials