Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers

Study Overview
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Brief Summary
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This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers. Primary Objective: To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.

Detailed Description
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Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.

Conditions
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Pneumococcal Infections, Pneumococcal Pneumonia

Intervention / Treatment
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* Biological: Pneumococcal Vaccine
* Biological: Pneumococcal Vaccine
* Biological: Pneumococcal Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 50 years on the day of inclusion Healthy, as determined by medical history and clinical examination Informed consent obtained Able to attend all scheduled visits and to comply with all trial procedures For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit For a woman of child-bearing potential: use of two medically acceptable, effective methods of contraception (oral contraceptive, intrauterine device, diaphragm, spermicide, or condom) or abstinence throughout the study participation starting at least 30 days prior to the first vaccination up to at least 30 days after the last vaccination. Exclusion Criteria: Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern For a woman, breast-feeding Participation in another clinical trial in the 30 days preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures Blood or blood-derived products received in the past 3 months Any vaccination in the 30 days preceding the first trial vaccination Vaccination planned in the 30 days following any trial vaccination Known Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity Known thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Febrile illness (≥ 38.0°C [or 100.4°F]) within 72 hours of inclusion/vaccination Previous vaccination in the preceding 5 years against pneumococcal disease with another vaccine History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years Subject at high risk of pneumococcal infection during the trial Subjects living in a household with children < 5 years of age Antibiotic usage or upper or lower respiratory tract infection within one week before any blood draw for immunogenicity (Visits 1, 3, and 5).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumococcal Vaccine Dose 1 (Low dose)<br>Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively. | Biological: Pneumococcal Vaccine<br>* 0.5 mL, intramuscular<br>|
| Experimental: Pneumococcal Vaccine Dose 2 (Middle dose)<br>Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively. | Biological: Pneumococcal Vaccine<br>* 0.5 mL, intramuscular<br>|
| Experimental: Pneumococcal Vaccine Dose 3 (High dose)<br>Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively. | Biological: Pneumococcal Vaccine<br>* 0.5 mL, intramuscular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia | Day 0 up to Day 60 post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of pneumococcal vaccine after 2 vaccinations | Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA). | Day 0 and 30 days post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal Infections, Pneumococcal Vaccines, pneumococcal protein