Invasive pneumococcal disease
Conditions
Interventions
Phase II
VCN11 vaccine candidate (Experimental group): A single dose of 0.5 mL, containing 2.2 µg of pneumococcal polysaccharides conjugated to TT, serotypes 1, 5, 6A, 9V, 14, 18C, 19A, 19F, 22F, 23F,
adsorbed on 0.125 milligrams of aluminum phosphate. It will administer by intramuscular route in the deltoid region.
Phase III
All subjects will receive the VCN11 vaccine candidate (experimental group
Sponsors
Finlay Vaccine Institute
Eligibility
Sex/Gender
All
Age
50 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Age between 50 and 74 years, both inclusive. 2. Subject who expresses written willingness to participate in the study by signing the informed consent.
Exclusion criteria
Exclusion criteria: Medical conditions: 1. Subject with mental and/or psychiatric disorders that prevent or limit the signing of the informed consent or follow-up in the study. 2. Subject with a reported history of invasive disease caused by Streptococcus pneumoniae, in the 6 months prior to the evaluation for inclusion in the study. 3. Subject with a reported history of having had a recent febrile illness or received antibiotic therapy for any acute illness in the 7 days prior to the evaluation for inclusion in the study. 4. Subject with known hypersensitivity to any component of the vaccine. 5. Subject with decompensated chronic disease(s) at the time of inclusion evaluation in the study. 6. Subject with a history of neoplastic disease who received cytostatic treatment in the two months prior to inclusion or who may require it during the course of the study due to an underlying condition. 7. Subject with known impairment of immune function. Previous or concomitant therapies: 8. Subject who has received any vaccine against Streptococcus pneumoniae. 9. Subject who received treatment with steroids within 30 days prior to inclusion or who may require it during the course of the study due to an underlying condition. 10. Subject who is receiving immunosuppressive therapy. 11. Subject who has received a transfusion of blood or blood products, including immunoglobulin, within 6 months prior to screening for inclusion in the study or is scheduled to receive a transfusion of blood or a blood product within 30 days of study vaccination. 12. Subject who has received any vaccine within 14 days prior to screening for inclusion in the study or is scheduled to receive any vaccine within 30 days of study vaccination. Prior/concurrent clinical trial experience: 13. Subject who is participating or has participated in an interventional clinical trial with an investigational compound or device within 2 months of being screened for inclusion in the study. Other exclusions: 14. Subject with a history of drug or alcohol use that may interfere with participation in specific activities in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Opsonophagocytic activity - OPA (Geometric mean titers (GMT) of serotype-specific opsonophagocytic activity). Measurement time: At baseline and 30 days post-vaccination. 2. Seroconversion (Defined as a 4-fold increase in serotype-specific opsonophagocytic activity titers after vaccination compared to the value reported prior to the intervention). Measurement time: At baseline and 30 days post-vaccination. 3. Adverse events-AE (Type of AE (Description of the adverse event presented according to the doctor's description), Severity of the AE (severe/serious, non-serious/non-serious), Intensity of the AE (mild, moderate, and severe), Causality of the AE (It will be classified as: A. With a causal association consistent with the vaccine or the vaccination process Events with a causal association consistent with the vaccine or any of its components. A1. Event related to the vaccine or any of its components. A2. Event related to a quality deviation of the vaccine. Events with a causal association consistent with the vaccination process. A3. Event related to a programmatic error. A4. Stress event that occurred immediately before, during, or immediately after the vaccination process. B. Undetermined. B1. The temporal relationship is consistent, but there is not enough definitive evidence to assign causality to the vaccine. B2. Factors determining classification show conflicting trends for and against a causal association with vaccination. C. No congruent causal association with the vaccine or vaccination (coincident event) The event is caused by an underlying or emerging disease or by a condition caused by exposure to something other than a vaccine. D. Not classifiable), Treatment of the AE (The treatment that the subject received to counteract the AE will be specified: medication, dose, route of administration, start and end date of the same), Result of the AE (recovered, recovered with sequelae, persists, death, unknown), Duration of the AE (= 24 hours, > 24-= 48 hours, | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anti-PsC IgG antibody concentration (µg/mL) of the common serotypes between VCN11 and Prevnar-13®, and the serotype 22F included in VCN11. The 95% credibility interval will be estimated for the ratio of the Geometric Means between the experimental group and the control group, and the increase in the geometric mean of the concentrations with respect to the pre-vaccination values (MGCpost/MGCpre) will also be estimated in each group, with the associated 95% confidence interval. Measurement time: At baseline and 30 days after vaccination. 2. Serotype-specific memory B cell levels for the vaccine candidate VCN11 and PCV13® (The 95% credibility interval will be estimated for the B cell levels for each serotype). Measurement time: At baseline and 30 days after vaccination. 3. Colonized serotype (Descriptive measurements will be made of % of colonized by pneumococcus and circulating serotypes). Measurement time: At baseline. | — |
Countries
Cuba
Contacts
Public ContactOdalis de la Guardia Penna
Institute of Hematology and Immunology (IHI)
Outcome results
None listed