study of two investigational pneumococcal vaccines in healthy adults

Conditions: Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Pneumonia

Summary: this study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults. primary objective: - to evaluate the safety and tolerability of two investigational pneumococcal vaccines. observational objective: - to evaluate the immunogenicity of the investigational pneumococcal vaccines.

an initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. after safety evaluation of that cohort, additional cohorts will receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or increased dose level. all participants will be monitored for safety for 30 days after each vaccination.

Eligibility criteria:
inclusion criteria: * aged 18 to 50 years on the day of inclusion * informed consent form has been signed and dated * able to attend all scheduled visits and comply with all trial procedures * subject is healthy, as determined by medical history and physical examination * for a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to first vaccination until 4 weeks after the last vaccination. exclusion criteria: * known pregnancy or positive serum/urine pregnancy test * currently breastfeeding a child * chronic illness, that in the opinion of the investigator, is at a stage that could interfere with trial conduct or completion * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * planned participation in another clinical trial during the present trial period * known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine(s) or to a vaccine containing any of the same substances * current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures * receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response * receipt of any vaccine in the 4 weeks preceding the first trial vaccination * planned receipt of any vaccine in the 4 weeks following the trial vaccination * known seropositivity for human immunodeficiency virus (hiv), hepatitis b or hepatitis c * laboratory confirmed / self-reported thrombocytopenia contraindicating intramuscular vaccination * deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * identified as a study site employee who is involved in the protocol and may have direct access to trial-related data * previous vaccination against pneumococcal disease (in the previous 5 years) * history of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years * at high risk for pneumococcal infection during the trial * living in a household with children \< 5 years of age.

Keywords: pneumococcal infections streptococcus pneumoniae infections pneumococcal vaccine