Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double Blind, Controlled by Conventional BCG, Dose-escalation Phase I Study, to Evaluate Safety, Tolerability and Immunogenicity of a Mycobacterium Bovis BCG (Bacillus Calmette-Guérin) Vaccine, 1331 Danish Strain, Live Attenuated and Recombinant for the Expression of Human Respiratory Syncytial Virus Nucleoprotein (N) in Healthy Males Within 18 and 50 Years of Age
Brief 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).


Options:
A: Inclusion Criteria:

* Male or female aged 1 through 9 years old
* In general good health
* Seropositive for RSV (enzyme-linked immunosorbent assay \[ELISA\] titer \> 12 U/ml) and PIV3 (hemagglutination-inhibition \[HAI\] titer \> 1:8)
* Subject's parent/legal representative available by telephone
* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's parent/legal representative
* Ability of the subject's parent/legal representative to understand and comply with the requirements of the protocol as judged by the investigator
* Ability to complete the follow-up period of 6 months following dosing as required by the protocol

Exclusion Criteria:

* Any fever and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization
* Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt of such therapy through the protocol-specified blood collection 28-35 days after study vaccine dosing
* Any current or expected receipt of systemic immunosuppressive agents including steroids; children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for less than or equal to 30 days
* Receipt of blood transfusion within 7 months prior to randomization or expected receipt through 35 days after study vaccine dosing
* Receipt of immunoglobulin products within 11 months prior to randomization or expected receipt through 35 days after study vaccine dosing
* Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after study vaccine dosing
* Receipt of any other live virus vaccine within 30 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
* Receipt of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
* History of Guillain-Barré syndrome
* Known or suspected immunodeficiency, including HIV
* Known or suspected acute or chronic hepatitis infection
* Living at home or attending day care with children less than or equal to 24 months of age
* Contact with pregnant caregiver
* Household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after study vaccine dosing
* History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc)
* Previous medical history, or evidence, of chronic illness may compromise the safety of the subject
* At screening any of the following laboratory tests outside of the laboratory normal range: complete blood count (CBC) with differential and platelet count, AST, ALT, blood urea nitrogen (BUN), creatinine, or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, is considered to be clinically significant or may potentially compromise the safety of the subject during the conduct of the study
* History of medically confirmed diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD)
* Passive primary household smoking
* Family member or household contact who is an employee of the research center with the conduct of the study
* Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
B: 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.
C: Inclusion Criteria:

* Current or part-time student at McMaster University
* 17 year of age or older
* Currently living:

  i. In residence or, ii. Off-campus with at least one student housemate
* Willing and able to sign an informed consent

Exclusion Criteria:

* Students who do not meet the inclusion criteria
* Currently living at home with parents
* History or diagnosis of hypercalcemia
* Diagnosis of parathyroid disorder (hyper or hypo)
* Diagnosis of chronic kidney disease
* Use of anticonvulsants
* Malabsorption syndromes
* Diagnosis of sarcoidosis
* Currently pregnant or planning a pregnancy
* Inability to swallow capsules
D: Inclusion Criteria:

* influenza like illness symptoms
* positive rapid test for influenza
* inclusion within 48h of symptom onset
* inclusion of at least 3 members of a household (including index case)

Exclusion Criteria:

* severe illness
* other cases of similar symptoms within 14 days before onset of symptoms in index patient
* severe asthma or COPD
* pregnancy of index

Answer: B