Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Human Parainfluenza Type 1 Virus Vaccine, rHPIV1 84/del170/942A, Lot PIV1 #104A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HPIV1-Seropositive Children 15 to 59 Months of Age, and HPIV1-Seronegative Infants and Children 6 to 59 Months of Age
Brief Summary: Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of viral croup in children under 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2 groups of adults and then in children who have been previously exposed to HPIV1. Once the safety of this vaccine has been established in these groups, an additional 2 groups of infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve infants and children are the most vulnerable to naturally circulating HPIV1 and are the target population of this vaccine.


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: Adult Inclusion Criteria:

* In good health
* Available for the duration of the trial
* Available for post-inoculation telephone contact
* For females, must agree to use effective birth control methods for the duration of the study

Seropositive Children Inclusion Criteria:

* In good health
* Seropositive for HPIV1
* Available for the duration of the study

Seronegative Infants and Children Inclusion Criteria:

* In good health
* Seronegative for HPIV1 antibody
* Available for the duration of the study

Adult Exclusion Criteria:

* Neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
* Condition, in the opinion of the investigator, that will not allow the participant to comply with the protocol
* Alcohol or drug abuse
* History of anaphylaxis
* History of splenectomy
* Diagnosis of asthma within 2 years of study entry
* HIV-infected
* Hepatitis C infection
* Hepatitis B infection
* Abnormal urinalysis
* Known immunodeficiency syndrome
* Current use of nasal or systemic steroid medications
* Receipt of blood products within 3 months of study entry
* Current smoker unwilling to stop smoking for the duration of the study. The decision to exclude a potential subject is made by the investigator based upon the potential subject's medical history and physical examination.
* Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine
* Receipt of live vaccine within 4 weeks or a killed vaccine within 2 weeks or immune globin within 3 months prior to receiving the investigational vaccine
* Previous immunization with an HPIV1 vaccine
* Known hypersensitivity to any vaccine component
* Participants whose profession and/or personal responsibilities involve caring for children less than 6 months of age or for immunosuppressed individuals
* Persistent systolic blood pressure more than 140 mm Hg or diastolic pressure more than 90 mm Hg
* Body mass index (BMI) more than 35
* Pregnant or breastfeeding

Seropositive and Seronegative Infants and Children Exclusion Criteria:

* Known or suspected impairment of immunological functions as determined by the investigator
* Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
* Previous immunization with HPIV1 vaccine
* Current use of nasal or systemic steroid medications
* Previous serious vaccine-associated adverse event or anaphylactic reaction
* Known hypersensitivity to any vaccine component
* Lung or heart disease, including reactive airway disease as determined by the investigator
* Member of household that includes an immunocompromised individual or infant less than 6 months of age
* Attends day care with infants less than 6 months of age or immunosuppressed individuals. More information about this criterion can be found in the protocol.
* Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine or while study is occurring
C: 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.
D: Inclusion Criteria:

* At least 6 months to less than 25 months of age at the time of enrollment
* Parents/guardians who demonstrate their understanding of the study (by taking the comprehension assessment), sign the informed consent, and agree to vaccine administration following detailed explanation of the study
* Seronegative for RSV antibody, defined as a serum RSV neutralizing antibody titer less than 1:40 as determined within 42 days prior to enrollment
* Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health
* In the view of the site investigator, the participant has received routine immunizations appropriate for their age
* Participant is expected to be available for the duration of the study

Exclusion Criteria:

* Known or suspected impairment of immunological functions, including maternal history of positive HIV test
* Receipt of immunosuppressive therapy including systemic corticosteroids within 30 days of study entry. NOTE: Topical steroids, topical antibiotic, and topical antifungal medications are acceptable within 24 hours of enrollment. May be reassessed after symptoms have resolved.
* Bone marrow/solid organ transplant recipients
* Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
* Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product
* Previous serious vaccine-associated AE or any anaphylactic reaction
* Known hypersensitivity to any vaccine component
* Lung or heart disease, including any wheezing event or reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
* Member of a household that includes an immunocompromised individual or infants less than 6 months of age
* Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
* Fever (rectal temperature of greater than or equal to 100.4°F \[38°C\]), or upper respiratory illness (rhinorrhea, cough, or pharyngitis) or nasal congestion (that is significant enough to interfere with successful vaccination), or otitis media
* Has received any killed vaccine or live attenuated rotavirus vaccine within the last 2 weeks, any other live vaccine within the last 4 weeks, or gamma globulin (or other antibody products) within the past 3 months or is scheduled to receive any immunization in the 28 days after enrollment
* Receipt of another investigational vaccine or investigational drug within 28 days of receiving this investigational RSV vaccine
* Has received antibiotics or systemic or nasal steroid therapy or other prescription medications for acute illness within 3 days of study entry. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) topical steroids, topical antibiotics, and topical antifungal agents.
* Has received salicylate (aspirin) or salicylate-containing products within the past month
* Infants born at less than 37 weeks gestation and less than 1 year of age

Answer: B