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)
Purpose
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.
Condition
- Pneumococcal Infections
Eligibility
- Eligible Ages
- Between 18 Years and 49 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental V114 |
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2) |
|
Active Comparator Prevnar 13™ |
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2) |
|
More Details
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC