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)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevnar 13™; PNEUMOVAX™23
Intervention description: 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose; 23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1515.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

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.