Heptavalent Conjugate Vaccine against Pneumococcal in healthy adults (VCN7-T).

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000133
• Date of registration: 20/07/2012
• Primary sponsor: Biomolecular Chemistry Center (CQB)
• Public title: Heptavalent Conjugate Vaccine against Pneumococcal in healthy adults (VCN7-T).
• Scientific title: Safety and immunogenicity of Heptavalent Conjugate Vaccine against Pneumococcal in healthy adults. Phase I.
• Date of first enrolment: 17/06/2012
• Target sample size: 40
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000133-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel Purpose: Prevention

Countries of recruitment

Cuba

Contacts

• Name: Beatriz Paredes Moreno
• Affiliation: Biomolecular Chemistry Center (CQB)

• Name: Beatriz Paredes Moreno
• Affiliation: Biomolecular Chemistry Center (CQB)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subjects aged between 18 and 35 (including the limit ages) 2. General, regional and specific physical examination without any alteration. 3. Vital signs within the following limits: - Sistolic Blood Pressure < 140 mmHg - Diastolic Blood Pressure < 90 mmHg - Heart rate80 ± 20 per minute - Respiratory rate16 ± 4 per minute - Temperature< 37 0C 4. Subject with hemoglobin rate above 12.5 g/L and other laboratory findings within the range of reference values. 5. Body Mass Index (BMI) between 18.5 and 29.9 (including the limits). 6. Subjects who express their consent to participate in the study written.
Exclusion criteria: 1. Chronic diseases such as Asthma, Chronic Obstructive Pulmonary Disease (COPD), Ischemic Heart Disease, High Blood Pressure (hypertension), Diabetes mellitus (DM), thyroid disease, Epilepsy, neuropathies or diseases of the haemolymphopoietic system. 2. Immunosuppresive diseases, either congenital or acquired. 3. Fever or acute infection within ten (10) days prior to vaccination or upon the shot. 4. Severe allergic disease or immune system diseases. 5. Renal and / or hepatic failure. 6. Hypersensitivity to thimerosal or any of the other components of the formulation. 7. Mentally handicapped 8. Convulsive encephalopathies 9. Immunostimulatory or immunosuppressive therapy, blood products or other vaccinations in a period of 2 months 10. Subject with a history of previous vaccination against Streptococcus pneumoniae 11. Alcoholism.

Age minimum: 18 years
Age maximum: 35 years
Gender: Male

Health Condition(s) or Problem(s) studied

Pneumococcal infection.

Intervention(s)

Both groups received the vaccine by intramuscular route. Study group: Single dose (0.5ml) of VCN7-T Heptavalent Pneumococcal Conjugate Vaccine. Control group: Single dose (0.5ml) PNEUMO 23 ® Polyvalent Pneumococcal vaccine. Sanofi Pasteur

Primary Outcome(s)

Adverse event (EA). Measurement time: Measurement time: 3 hours, 24 hours, 48 hours, 72 hours and 30 days after immunization • Description of EA: report of adverse event • Duration of EA: Date of beginning and end of the event reported • Intensity of EA: mild, moderate and severe • Severity of EA: serious or not serious • Results of the EA: recovered, recovered with sequelae, persistence when the subject concludes the study, death and unknown • Relationship Causality: related and unrelated.

Secondary Outcome(s)

Seroprotection (Concentrations of antibodies for each serotype PsC greater than or equal to 0.20 mg / mL and titles opsonophagocytic greater or equal to 1:8). Measurement time: 30 days after immunization

Secondary ID(s)

CQB/NEU/11/EC-I/01

Source(s) of Monetary Support

Biomolecular Chemistry Center (CQB)

Secondary Sponsor(s)

Finlay Institute