A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: rBCG-N-hRSV 1/100; rBCG-N-hRSV 1/10; rBCG-N-hRSV full dose; Conventional BCG full dose
Intervention description: 5x10^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.; 5x10^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.; 1x10^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.; 2x10^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: human Respiratory Syncytial Virus; Phase I; Recombinant BCG vaccine

Summary:

      Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract
      infection in children under one year of age. This study will evaluate the safety,
      tolerability and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine that
      expresses the human Respiratory Syncytial Virus Nucleoprotein (N), in adult males (18 to 50
      years of age).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chilean male within 18 and 50 years old.

          -  To have accepted his voluntary participation through the sign of the informed consent.

          -  To be in good health, according to the medical history, physical examination and
             normal laboratory tests.

          -  To be vaccinated with BCG once or twice during his life.

        Exclusion Criteria:

          -  Symptoms or diagnosis suggesting some systemic disease including renal, liver,
             cardiovascular or pulmonary impairment, immunodeficiency, autoimmune disease,
             malignancies, psychiatric or other conditions that can interfere on the interpretation
             of the results or compromise the health of the participants.

          -  Body mass index lower than 19 and higher that 30 kg/m2 and/or weight under 50 kg.

          -  Not being able to attend all the study visits (face-to-face and call phones) or not
             follow the specified instructions (fasting, not doing intense physical exercise during
             the previous 24 hours to the visits and 72 hours post-vaccine).

          -  Signs of latent or active infectious diseases by Mycobacterium tuberculosis (TB):
             QuantiFERON-TB positive test or Chest X-ray suggesting Tuberculosis (TBC).

          -  Positive screening for Human Immunodeficiency Virus (HIV), Hepatitis B superficial
             antigen (HBsAG) and anti-Hepatitis C Virus (HCV).

          -  Evidence of primary or secondary immunodeficiency, determined by history, physical
             test and levels of serum immunoglobulins and lymphocytes sub-populations at the
             screening.

          -  Use of immunosuppressors during the last 6 months previous to the visit.

          -  Use of inhaled corticosteroids during the last year or with antecedents of bronchial
             hyper-reactivity.

          -  Antecedents of intradomiciliary contact with subjects with Tuberculosis or other
             mycobacteria, even when he/she is under treatment.

          -  Antecedents of substance abuse (drugs or alcohol), according to DSM IV (See footnote*)

          -  Occurrence of any serious adverse event associated to the previous BCG vaccination.

          -  History of severe allergic reaction or anaphylaxis to vaccines

          -  History of severe infections (use of IV antibiotics, opportunist, latent TBC, herpes
             zoster) during six months previous to the visit.

          -  Not use or rejection to the use of contraceptives during the whole study (See
             footnote**).

          -  Administration of Immunoglobulins or blood-derived products during the six months
             previous to the visit or the planning of its use during the study.

          -  Eczema at the vaccination site (deltoid zone).

          -  Antecedents of keloid scar.

          -  Being vaccinated with BCG during the last 10 years.

          -  History of being vaccinated with BCG three or more times or the presence of three BCG
             scars.

          -  Using other investigational products during the 30 days previous to the study.

          -  Administration of any vaccine during the 8 weeks previous to the recruitment.

          -  Planned administration of any other different vaccine 30 days after the vaccination
             with the rBCG-N-hRSV.

          -  Acute illness symptoms and/or feverish symptoms at the time or during the last seven
             days previous to the recruitment (fever defined as an oral or axillary temperature of
             >38ºC).

        (*) Substance abuse (drugs or alcohol): Maladaptive pattern of substance abuse that leads
        to a deterioration or clinical significant discomfort, expressed by one or more associated
        problems, during a time of twelve months, in one of the four vitals areas: inability to
        achieve main obligations; consume in dangerous situations, such as driving a vehicle; legal
        problems; consume despite the social and interpersonal difficulties associated.

        (**) Given the remote possibility of negative effects produced by the vaccination in the
        sperm, the recruitment will be performed only to volunteers that are not planning of
        conceiving a child during the study duration. In each visit, the abstinence fulfillment
        will be checked or the use of effective contraceptive.

        Eligibility criteria:

        The eligibility of the volunteers will be performed if they fulfill the inclusion criteria
        and fulfill none of the mentioned exclusion criteria, also presenting all the normal
        screening study.

        All the volunteers must sign the Informed consent approved by the Ethic Committee of the
        "Facultad de Medicina" of the "Pontificia Universidad Católica de Chile", before starting
        the first screening visit.