A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya

This is an interventional prevention trial for Pneumonia focused on measuring Vaccine Read More

Inclusion Criteria:

• Healthy adults who are 18 to 40 years old, or toddlers who are 12 to 19 months old.
• Must provide voluntary written/thumb-printed informed consent
• Must comply with study requirements and procedures.
• Must have an identifiable place of residence to allow home visits, and a consistent means of telephone contact
• Must be resident in the study area with no plans to travel outside the study area during the study
• Must be willing to not take herbal or other local traditional medications within 28 days of randomization and during the course of the study
• Adult female subjects must have a negative serum pregnancy test at screening and urine pregnancy test prior to each vaccination
• Toddlers must have been born full-term, and have a mid-upper arm circumference > 11.5 cm at the time of enrollment.
• Toddlers must have completed their Kenyan infant EPI schedule through 9 months including 1 birth dose of BCG, 3 doses of DTwPHibHep, 3 doses of OPV (birth dose is not required), 3 doses of PCV, and 1 dose of measles vaccine

Exclusion Criteria:

• Use of any investigational or nonregistered drug within 90 days of enrollment
• Use of any potentially hepatotoxic drug
• Receipt of any licensed vaccine within 14 days of administration of study vaccine.
• Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, based on medical history or clinical assessment
• History of anaphylactic shock
• History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines
• History of immunosuppression or immunodeficiency, inclusive of human immunodeficiency virus (HIV) infection by medical history (including that of an enrolled toddler's mother) or by HIV testing at screening
• Evidence of active hepatitis infection (B or C) by serologic testing at screening.
• Any screening laboratory test (chemistry or hematology) or vital sign measurement with toxicity grade ≥ 1
• Acute illness (moderate or severe) and/or fever (axillary temperature ≥ 37.5°C)
• Positive test for malaria (blood film) at screening that remains positive post treatment when retested prior to vaccination
• Disorders that require chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within the past 6 months prior to the administration of the study vaccine.
• Administration of immunoglobulins and/or any blood products within the 6 months preceding enrollment in the study
• Known disturbance of coagulation or other blood disorder (e.g., thalassemia, sickle cell disease, thrombocytopenia, disorders of the lymphocytes, severe anemia at birth) in adult subject or in self/first-degree relative of toddler subject; or receipt of anticoagulants in the past three weeks (aspirin as needed and nonsteroidal anti-inflammatory drugs are acceptable)
• History of meningitis, seizures or any neurological disorder (all participants) or major psychiatric disorder (adults)
• Any medical or social condition that in the opinion of the investigator will interfere with the study objectives or pose a risk to the study subject
• An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel
• Female adult subjects who are pregnant or breast-feeding
• Adults with a recent history (within the past year) of alcohol or substance abuse.
• Toddlers who have already received a pentavalent booster (following the primary series).
• Toddlers with a family history of suspected primary immunodeficiency in first-degree relative.
• Toddlers who had a sibling die of likely sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life.
• Toddlers with evidence of a clinically significant congenital abnormality as judged by the PI.
• Toddlers with evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy