RV568 - Viral Challenge With RSV

This study has been completed.
Sponsor:
Information provided by:
Respivert Ltd
ClinicalTrials.gov Identifier:
NCT01230645
First received: October 27, 2010
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is effective in reducing the inflammation caused by viral infections such as RSV (respiratory syncytial virus).


Condition Intervention Phase
Respiratory Syncytial Virus Infections
Drug: RV568
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Single-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Intranasal RV568 (400μg) Administered Twice Daily to Adult Male Volunteers Experimentally Inoculated With Live Respiratory Syncytial Virus

Resource links provided by NLM:


Further study details as provided by Respivert Ltd:

Primary Outcome Measures:
  • IL8 induction in nasal wash samples [ Time Frame: 16 day quarantine period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RSV viral load [ Time Frame: 16 day quarantine period ] [ Designated as safety issue: No ]
  • Changes in symptoms of RSV infection [ Time Frame: 16 day quarantine period ] [ Designated as safety issue: No ]
  • Assessment of mucus weight and tissue counts [ Time Frame: 16 day quarantine period ] [ Designated as safety issue: No ]
  • Viable nasal cell counts in nasal washes [ Time Frame: 16 day quarantine period ] [ Designated as safety issue: No ]
  • Frequency of RSV infection [ Time Frame: 16 day quarantine period ] [ Designated as safety issue: No ]
  • Plasma RV568 levels [ Time Frame: 16 day quarantine period ] [ Designated as safety issue: No ]
  • Assessment of IL6 in nasal wash samples [ Time Frame: 16 day quarantine period ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RV568 treatment group Drug: RV568
RV568 400 ug administered as nasal drops twice daily for 10 days (Day -1 to Day 8)
Placebo Comparator: Placebo treatment group Drug: Placebo
Placebo administered as nasal drops twice daily for 10 days (Day -1 to Day 8)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male subjects aged 18 - 45 years
  • agreeable to use adequate contraception throughout the study
  • negative hepatitis B, hepatitis C and HIV screen
  • negative drugs of abuse, alcohol and nicotine screen
  • able to provide written informed consent and be willing to comply with the study restrictions and requirements
  • low titres of RSV neutralising antibody measured during screening

Exclusion Criteria:

  • acute or chronic illness or clinically relevant abnormality noted at the screening visit
  • presence of febrile illness or symptoms of upper or lower respiratory tract infection in the 28 days prior to viral inoculation
  • history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition
  • diabetes
  • history or evidence of autoimmune disease or known impaired immune responsiveness
  • recent (within the last 3 years) and/or recurrent history of autonomic dysfunction
  • anatomic or neurological abnormality impairing the gag reflex or associated with an increased risk of aspiration, any abnormality significantly altering the anatomy of the nose or nasopharynx. Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome. Any nasal or sinus surgery within 4 months prior to virus administration.
  • history of smoking in the past 6 months
  • positive test for drugs or alcohol at screening
  • inadequate venous access
  • abnormal pulmonary function at screening
  • abnormal laboratory or ECG at screening
  • acute or chronic use of medication to treat nasal congestion
  • use of any prescription drugs, herbal supplements, within 4 weeks prior to virus challenge, and/or over-the-counter medication, dietary supplements within 2 weeks prior to virus challenge
  • treatment with systemic glucocorticoids, antiviral drugs, immunoglobulins or blood transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months prior to dosing. Receipt of any systemic chemotherapy agent at any time
  • treatment with any investigational drug within 3 months, or prior participation in a clinical trial of any RSV IMP, medication or experimental RSV viral challenge delivered directly to the respiratory tract within 1 year prior to dosing, or receipt of more than 4 investigational drug within 12 months
  • history of multiple and recurring allergies and/or adverse reaction to any components of the challenge virus preparation
  • allergy to gentamicin
  • significant history of seasonal hay fever or seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or chronic nasal or sinus condition
  • intention to travel between first and last visit (to countries for which vaccinations are recommended or where high risk of infection exists)
  • healthcare workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge
  • household member or close contact (for an additional 2 weeks after discharge from the isolation facility) who is:

    1. less than 3 years of age;
    2. any person with any known immunodeficiency;
    3. any person receiving immunosuppressant medications;
    4. any person undergoing or soon to undergo cancer chemotherapy within 28 days of viral challenge;
    5. any person who has diagnosed emphysema or COPD, is elderly residing in a nursing home, or with severe lung disease or medical condition including but not exclusive to the conditions listed below; or
    6. any person who has received a transplant (bone marrow or solid organ)
  • employees or relatives of Retroscreen Virology or RespiVert Ltd
  • other finding in the medical interview, physical exam, or screening investigations that, in the opinion of the Investigator, deem the subject unsuitable for the study
  • subjects who in the opinion of their general practitioner or the Investigator, should not participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230645

Locations
United Kingdom
Retroscreen Virology Ltd
London, United Kingdom, NW1 0NH
Sponsors and Collaborators
Respivert Ltd
Investigators
Principal Investigator: Anthony Gilbert, MD Retroscreen Virology Ltd.
  More Information

No publications provided

Responsible Party: Dr Garth Rapeport, Respivert Ltd
ClinicalTrials.gov Identifier: NCT01230645     History of Changes
Other Study ID Numbers: RVH003, 2010-021527-26
Study First Received: October 27, 2010
Last Updated: February 10, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on July 22, 2014