a study to evaluate the safety, tolerability, and immunogenicity of v114 followed by pneumovax™23 in adults at increased risk for pneumococcal disease (v114-017/pneu-day)

Conditions: Pneumococcal Infections

Summary: this study is designed to 1) describe the safety, tolerability, and immunogenicity of v114 and prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of pneumovax™23 when administered 6 months after receipt of either v114 or prevnar 13™. increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.


Eligibility criteria:
inclusion criteria: * native american participant enrolled from any of the clinical sites of the johns hopkins center for american indian health (caih) without any of the pre-specified risk conditions for pneumococcal disease listed below, or native american participant enrolled from any of the caih sites or participant from a site other than caih with ≥1 of the following risk conditions for pneumococcal disease: 1. diabetes mellitus type 1 or type 2 and with hemoglobin a1c (hga1c) \<10% 2. chronic liver disease with documented history of compensated cirrhosis (child-pugh score a) 3. confirmed diagnosis of chronic obstructive pulmonary disease (copd) with spirometric global initiative for chronic obstructive lung disease stage 1 to 3 4. confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy 5. confirmed diagnosis of chronic heart disease (new york heart association \[nyha\] heart failure class 1 to 3, receiving guideline-directed oral heart failure treatment) due to reduced or preserved ejection fraction or due to non-cyanotic congenital heart disease. 6. current smoker * female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after last administration of study vaccine. exclusion criteria: * history of active hepatitis within the prior 3 months * history of diabetic ketoacidosis, or \>1 episodes of severe, symptomatic hypoglycemia within the prior 3 months * myocardial infarction, acute coronary syndrome, transient ischemic attack, and ischemic or hemorrhagic stroke within the prior 3 months * history of severe pulmonary hypertension or history of eisenmenger syndrome * history of invasive pneumococcal disease (ipd) or known history of other culture-positive pneumococcal disease within the prior 3 years * known hypersensitivity to any vaccine component, pneumococcal conjugate vaccine, or diphtheria toxoid-containing vaccine * known or suspected impairment of immunological function (including human immunodeficiency virus (hiv) infection or autoimmune disease) * history of malignancy within the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * history of stage 4 or 5 chronic kidney disease or nephrotic syndrome * history of alcohol withdrawal or alcohol withdrawal seizure within the prior 12 months * history of coagulation disorder contraindicating intramuscular vaccination * history of hospitalization within the prior 3 months * planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgery during the duration of this study. * expected survival for less than 1 year according to the investigator's judgment. * female participant: positive urine or serum pregnancy test * prior administration of any pneumococcal vaccine * received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed within the prior 30 days * received systemic corticosteroids exceeding physiologic replacement doses within 14 days before study vaccination * receiving immunosuppressive or immunomodulatory therapy with a biological agent * received any licensed, non-live vaccine within 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of study vaccine * received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine * received a blood transfusion or blood products within the prior 6 months * receiving chronic home oxygen therapy * participated in another clinical study of an investigational product within the prior 2 months * current user of recreational or illicit drugs or history of drug abuse or dependence * diabetes mellitus with hga1c ≥10% * chronic liver disease with child-pugh class b or c cirrhosis * chronic lung disease with chronic obstructive pulmonary disease (copd) gold stage 4 or severe persistent asthma * chronic heart disease with nyha heart failure class 4.