Phase II-III study to evaluate the safety and immunogenicity of the pneumococcal vaccine candidate VCN11 in adult participants aged 50 to 74 years.

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

Pneumo11 adults

Scientific title:

Phase II-III, combination of stages, controlled, randomized, double-blind in phase II, non-inferiority, adaptive and multicenter clinical trial, to evaluate the immunogenicity, safety and efficacy of the 11-valent pneumococcal conjugate vaccine candidate (VCN11) in adults

Secondary indentifying numbers:

IFV/NEU/07

Issuing authority of the secondary identifying numbers:

Finlay Vaccine Institute

Source(s) of monetary or material support:

Science and Innovation Financial Fund ( FONCI )

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Odalis

Midle name:

Maria

Last name:

de la Guardia Penna

Medical Specialty :

Second degree specialist in Immunology

Affiliation:

Institute of Hematology and Immunology (IHI)

Postal address:

Calle 19 entre 8 y 10, Vedado. Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-52668795

Email address:

odalism@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, April 19 Polyclinic, Armando Orrellana Molina MD., First Degree Specialist in Comprehensive General Medicine.

Havana, Abelardo Ramirez Polyclinic, Liz Caballero González MD, First Degree Specialist in Comprehensive General Medicine

Havana, Polyclinic Cosme Ordonnez, Marita Tiel Marin MD, First Degree Specialist in Comprehensive General Medicine.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

08/01/2025

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Invasive pneumococcal disease

Intervention(s):

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, and 4.4 µg of serotype 6B, adjuvanted with aluminum phosphate (0.125 mg), in saline solution and thiomersal 0.025 mg. It will administer by intramuscular route in the deltoid region. Commercial vaccine Prevnar13®, from Pfizer (Control group): A single dose of 0.5 mL, containing 2.2 µg of pneumococcal polysaccharides serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4 µg of serotype 6B, conjugated to CRM197 as a carrier protein; 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)

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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, > 48-≤ 72 hours, more than 72 hours), Onset of AE (60 minutes, ≤ 24 hours, > 24-≤ 48 hours, > 48-≤ 72 hours, more than 72 hours)). Measurement time: From vaccination to 30 days post-vaccination. 4. Vital signs (systolic/diastolic blood pressure (mmHg), heart rate (HR; beats/min.), respiratory rate (RR; inspirations/min.), temperature (T; °C)). Measurement time: Before and, after administration 5. Clinical laboratory tests (These studies will be performed on 50 participants (25 in each group) who will be included in stage IIa. A blood sample (10 mL) will be obtained, before and after vaccination, to perform hematological studies (blood count with differential) and blood chemistry (glycemia, creatinine and transaminases)). Measurement time: At baseline and, 30 days post-vaccination.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

50 years

Maximum age:

74 years

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:

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.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

2-3

Target sample size:

1001

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Odalis

Middle Name:

Maria

Last Name:

de la Guardia Penna

Specialty:

Second degree specialist in Immunology

Affiliation:

Institute of Hematology and Immunology (IHI)

Postal Address:

Calle 19 entre 8 y 10, Vedado. Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-52668795

Email :

odalism@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Odalis

Middle Name:

Maria

Last Name:

de la Guardia Penna

Specialty:

Second degree specialist in Immunology

Affiliation:

Institute of Hematology and Immunology (IHI)

Postal Address:

Calle 19 entre 8 y 10, Vedado. Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-52668795

Email :

odalism@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Institute of Hematology and Immunology (IHI) (Centralized)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

16/12/2024

Postal address of Ethic Committee :

Calle 8 No. 460, entre 17 y 19, Vedado, Plaza de la Revolución, CP: 10400, La Habana, Cuba

Telephone:

+53-53235548

Correo electrónico:

yeniseyt@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/06/2025

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000453

Date of Registration in Primary Registry:

27/12/2024

Record Verification Date:

2024/12/27

Next update date:

2025/12/27

Link to the spanish version:

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Phase II-III study to evaluate the safety and immunogenicity of the pneumococcal vaccine candidate VCN11 in adult participants aged 50 to 74 years.

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