Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 1 Randomized, Observer Blind, Placebo Controlled, Dosage-Escalation Single Center Study to Evaluate the Safety and Immunogenicity of an RSV Fusion Glycoprotein (F) Subunit Vaccine in Healthy Adults
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM). In this current Phase 1, first-in-human study, the three different antigen amounts that have been selected will be evaluated in a stepwise manner in three different cohorts (Cohort 1: low dosage of RSV F subunit vaccine, Cohort 2: middle dosage of RSV F subunit vaccine, and Cohort 3: high dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels.


Options:
A: Inclusion Criteria:

1. Apparently healthy residents of selected vaccination sites
2. Aged 1 year and above
3. Non-pregnant women
4. Written informed consent

Exclusion Criteria:

1. Age less than 1 year
2. Pregnant women
B: Inclusion Criteria:

* Persons ≥ 5 years old: Influenza-like illness (ILI), defined as history of fever and either cough or sore throat with fever onset within the previous 24 hours
* Persons \< 5 years old: any child with acute fever with onset within the previous 24 hours
* Return to home within 24 hours of presentation to Upazilla Health Complex, Jahurul Islam Medical College Hospital or the local pharmacies; i.e., the index case cannot be admitted for treatment. If admitted, the patient would not be eligible.
* No fever in any bari resident during the 7 days preceding the patient's presentation to hospital (see definition below)
* At least two persons (in addition to the index case-patient) who intend to reside in the bari during the subsequent 20 days
* Residence within 30 minutes travel time (one-way) from the Upazilla Health Complex or Jahurul Islam Medical College Hospital or the local pharmacy.
C: 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.
D: Inclusion Criteria:

1. Healthy males and non-pregnant females 18 to 45 years of age at time of enrollment.
2. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
3. Individuals in good health as determined by the outcome of the medical history, physical examination and clinical judgment of the investigator.
4. Individuals who can comply with the study procedures and are available for follow up.

Exclusion Criteria:

1. Individuals with any severe chronic or acute disease.
2. Individuals with a history of illness or with an ongoing illness that may pose additional risk to the subject if he/she participates in the study, including the following:

   * History of any chronic respiratory illness, including current diagnosis of asthma within 2 years, exercise induced wheezing, reactive airway disease, emphysema, chronic bronchitis, cystic fibrosis or chronic obstructive pulmonary disease (COPD).
   * Any respiratory illness within 7 days prior to receiving the first study injection.
   * Any active pulmonary infection or other inflammatory conditions, even in the absence of febrile episodes, within 14 days prior to the first study injection.
   * Hepatitis B or hepatitis C infection.
3. Individuals who have had a malignancy or lymphoproliferative disorder within the past 5 years.
4. Individuals with known or suspected impairment of the immune system including but not limited to HIV, autoimmune disorders, immunosuppressive therapy, and diabetes mellitus.
5. Individuals with any history of progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome.
6. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
7. Individuals with a BMI \> 35 kg/m2. BMI is to be calculated by the following formula: subject weight at baseline divided by subject height in meters multiplied by the subject height in meters. The numerical result will be rounded to the nearest 0.1.
8. Individuals who are allergic to any of the vaccine components, or with a history of anaphylaxis after vaccination.
9. Individuals who during the 90 days prior to enrollment receive any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity.
10. Individuals who receive systemic immunosuppressive agents including steroids. Prior corticosteroid therapy should be discontinued 28 days prior to enrollment. Individuals using inhaled or topical corticosteroids will be permitted.
11. Receipt or donation of blood or blood products 8 weeks prior to vaccination or planned receipt or donation during the study period.
12. Individuals participating in any clinical trial with another investigational product 28 days prior to receiving the first study vaccination or intent to participate in another clinical study at any time during the conduct of this study.
13. Individuals who have received any vaccine 28 days prior to enrollment in this study, or who plan to receive any non-study vaccines within 28 days of the second dose of study vaccine.
14. Individuals with any clinically significant abnormal safety laboratory result, as judged by the investigator.
15. If female, 'of childbearing potential', sexually active and has not used any of the 'acceptable contraceptive methods' for at least two months prior to study entry.

    Childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least two years; sterile status after bilateral tubal ligation for at least one year, immediately after bilateral oophorectomy or after hysterectomy.

    Acceptable methods of birth control are defined as one or more of the following:
    * Hormonal contraceptives.
    * Barrier each and every time during intercourse.
    * Intrauterine device (IUD).
    * Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to subject's study entry.
16. If female subject of childbearing potential and have a positive urine pregnancy test prior to study vaccinations, or are currently lactating.
17. If female of childbearing potential and sexually active, refusal to use an 'acceptable contraceptive method' through to three weeks after last study vaccination.
18. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
19. Individuals with a history of drug or alcohol abuse within the past 2 years.
20. Individuals who are acting as study personnel or immediate family members or the spouse of study personnel.
21. Individuals with a body temperature ≥38 °C (≥100.4◦F) within 3 days of intended study vaccination.
22. Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives.

Answer: D