Phase Ib Clinical Trial of Recombinant Pneumococcal Protein Vaccine

Streptococcus pneumoniae infections often cause serious health problems, especially in infants and the elderly. Failure to cover all polysaccharide types of vaccines is a greater problem for adults than for children.The purpose of this study was to preliminarily evaluate the safety and immunogenicity of a recombinant pneumococcal protein vaccine applied to adults aged 50 years and older to provide a basis for subsequent clinical trial design.

Inclusion Criteria:Adults 50 years and older at the time of screeningWillingness to provide legal proof of identityAbility to understand the clinical study and voluntarily sign an informed consent form and complete a 6-month follow-upAbility to comply with the requirements of the clinical research protocolExclusion Criteria:Fever, axillary body temperature >37.0℃ before vaccinationPositive human immunodeficiency virus (HIV) screeningHistory of epilepsy, convulsions or seizures or a history of psychiatric illness or family historyReceived immunosuppressive therapy, cytotoxic therapy, glucocorticoid therapy (excluding topical therapy, surface therapy for acute uncomplicated dermatitis, spray therapy for allergic rhinitis) within the past 6 months (interval <6 months)Suffering from serious chronic diseases or conditions in progress that can't be controlled smoothly, such as serious cardiovascular diseases, chronic hemolytic anemia, thyroid diseases, etc. (except thyroid nodules)History of severe anaphylactic reactions (e.g., systemic allergic reactions) to any component of the test drug and/or history of serious adverse reactions associated with other vaccines, such as allergy, urticaria, dyspnea, angioneurotic edema, or abdominal painPeople with hypertension that cannot be controlled by medication (when measured on site: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure is ≥ 100 mmHg)Pre-immune hemoglobin, white blood cell count, alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatine phosphokinase (CPK), and troponin (CTN) test results are abnormal and are judged by the investigator to be clinically significantPositive urine pregnancy test or lactating women, volunteers or their partners planning to become pregnantDiseases caused by Streptococcus pneumoniae such as pneumococcal pneumonia, pneumococcal meningitis, etc. within the last 5 yearsAllergic persons, such as those who are allergic to two or more drugs or foods or those who are severely allergic to one drug or foodImmunocompromised individuals with known or suspected congenital/acquired immunodeficiency as determined by medical history and/or physical examination, uncontrolled autoimmune diseases, etcAbnormal coagulation (e.g., clotting factor deficiency, coagulopathy, platelet abnormalities) or significant bruising or clotting disordersNo spleen or splenectomy due to any conditionAcute attack of various acute or chronic diseases within the last 7 daysPneumococcal vaccination within the last 5 yearsReceived or planned to receive blood/plasma products or immunoglobulins during the study period or 3 months prior to vaccinationReceived or plan to participate in an interventional study, receive another investigational drug, vaccine or treatment during the study within the last 1 monthReceived live attenuated vaccine within the last 14 daysReceived subunit vaccine or inactivated vaccine within the last 7 daysThose planning to have surgery during the study periodSubject has any other factors that, in the judgment of the investigator, make them unsuitable for participation in the clinical trial