Revisiones para Phase III study of the Cuban vaccine candidate VCN7-T in patients from 1 to 18 years of age at risk of pneumococcal disease in Havana | Registro Público Cubano de Ensayos Clínicos

--- 4 Octubre 2023 - 12:11pm por FINLAY
+++ 5 Octubre 2023 - 9:44am por FINLAY
-. Patients over one year old included in the risk groups defined in the health areas of the province of Havana.
+. Patients from 1 to 18 years of age included in the risk groups defined in the health areas of the province of Havana.
 . Informed consent of parents and assent of adolescents for vaccination and follow-up.
 . Previous pneumococcal vaccination.
-. Children with a referred allergy to thiomersal or any biological product or vaccines causing a serious adverse reaction such as anaphylaxis.
+. Allergy related to thiomersal, or any biological product or vaccines with a serious adverse reaction such as anaphylaxis.
-. Decompensation of the underlying disease at the time of evaluation
+. Decompensation of the underlying disease at the time of evaluation.
-. Acute infectious diseases
+. Acute febrile or infectious illness at the time of application of the vaccine candidate, or in the previous 7 days.
+. Have been vaccinated according to the Cuban immunization schedule, in a period of less than 15 days prior to the application of the investigational product.
+. Pregnancy or amenorrhea greater than 4 weeks before the application of the vaccine candidate.

Phase III study of the Cuban vaccine candidate VCN7-T in patients from 1 to 18 years of age at risk of pneumococcal disease in Havana

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:

NRH

Scientific title:

Evaluation of the safety, immunogenicity and clinical effectiveness of the application of the Cuban anti-pneumococcal vaccine candidate PCV7-T, in patients from one to 18 years of age at risk of pneumococcal disease in the province of Havana. Phase III

Acronym of Scientific Title:

NRH/24

Secondary indentifying numbers:

IFV/NEU/05

Issuing authority of the secondary identifying numbers:

Finlay Vaccine Institute (FVI)

Source(s) of monetary or material support:

Cuban Fund for Science and Innovation (CFSI), of the Ministry of Science, Technology and Environment; Finlay Vaccine Institute (FVI)

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:

Rinaldo

Last name:

Puga Gomez

Medical Specialty :

Pediatrics Second Degree Specialist

Affiliation:

“Cira Garcia” Central Clinic

Postal address:

18 Street corner Ave 43, No. 4304. Miramar

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72042811

Email address:

puga@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, Playa, September 5 Polyclinic, MD. Jose Ariel Guevara, MGI First Grade Specialist

Havana, Playa, Isidro de Armas Polyclinic, MD. Yissel Pestana Alvarez, MGI First Grade Specialist

Havana, Playa, Ana Betancourt Polyclinic, MD. Hemnis Lopez Raymond, MGI First Grade Specialist

Havana, Plaza, Abelardo Ramirez Polyclinic, MD. Liz Caballero González, MGI First Grade Specialist

Havana, Plaza, Cosme Ordonnez Polyclinic, MD. Jessica Media Villa, MGI First Grade Specialist

Havana, Centro Habana, Marcio Manduley Polyclinic, BSN. Magalys Caridad Rodriguez Bannos, Degree in Nursing

Havana, Centro Habana, Van Troi Polyclinic, MD. Orestes Leyva Tamarit, MGI First Grade Specialist

Havana, Habana Vieja, Diego Tamayo Polyclinic, MD. Yeni Nunnez Fernandez, MGI First Grade Specialist

Havana, Habana Vieja, Tomas Romay Polyclinic, MD. Jorge Gonzalez Perez, MGI First Grade Specialist

Havana, Regla, Lidia and Clodomira Polyclinic, BSN. Iliana Lopez Caro, Degree in Nursing

Havana, Habana del Este, Camilo Cienfuegos Polyclinic, MD. Isabel Escalona Gutierrez, MGI First Grade Specialist

Havana, Habana del Este, March 13 Polyclinic, MD. Yamile Hurtado Fonseca, MGI First Grade Specialist

Havana, Habana del Este, Mario Munnoz Polyclinic, MD. Ailet Moya, MGI First Grade Specialist

Havana, Guanabacoa, Andres Ortiz Polyclinic, MD. Marlen Arencibia Reyes, MGI First Grade Specialist

Havana, Guanabacoa, Julio A. Mella Polyclinic, MD. Olga Borges Ojeda, MGI First Grade Specialist

Havana, San Miguel del Padron, Bernardo Posse Polyclinic, MD. Manuela Boris Gonzalez, MGI First Grade Specialist

Havana, San Miguel del Padron, Hermanos Ruiz Aboy Polyclinic, MD. Dannet Tellez Gomez, MGI First Grade Specialist

Havana, 10 de Octubre, Luyano Polyclinic, MD. Ivette de la Fuente Sanz, MGI First Grade Specialist

Havana, 10 de Octubre, Turcios Lima Polyclinic, MD. Ilena Allison Megret, MGI First Grade Specialist

Havana, 10 de Octubre, Raul Gómez Garcia Polyclinic, MD. Joselin Testa Arcia, MGI First Grade Specialist

Havana, Cerro, Heroes de Giron Polyclinic, MD. Marlene Maria Molina Almanza, MGI First Grade Specialist

Havana, Cerro, Antonio Maceo Polyclinic, MD. Vladimir Martinez Caboverde, MGI First Grade Specialist

Havana, Marianao, November 27 Polyclinic, MD. William Camayeri Fajardo, MGI First Grade Specialist

Havana, Marianao, Ramón Gonzalez Coro Polyclinic, MD. Regla Abarca Delgado, MGI First Grade Specialist

Havana, La Lisa, Cristobal Labra Polyclinic, MD. Nancy Servillo de la Paz, MGI First Grade Specialist

Havana, La Lisa, Pulido Humarán Polyclinic, MD. Nivaldo Yordanis Leyva Serrano, MGI First Grade Specialist

Havana, Boyeros, Wajay Polyclinic, MD. Diana Boloy Bannos, MGI First Grade Specialist

Havana, Boyeros, Mulgoba Polyclinic, MD. Eliuska Laurencio Molina, MGI First Grade Specialist

Havana, Boyeros, Salvador Allende Polyclinic, BSN. Odalys Vazquez Báez VDMC, Degree in Nursing

Havana, Arroyo Naranjo, Grimau Polyclinic, MD. Armando Tabares Correa, MGI First Grade Specialist

Havana, Arroyo Naranjo, Capri Polyclinic, MD. Teresa Justiniani Fresnada, MGI First Grade Specialist

Havana, Cotorro, Efrain Mayor Polyclinic, MD. Jose Luis Albelo Hidalgo, MGI First Grade Specialist

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

04/10/2023

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:

Pneumococcal diseases

Health condition(s) code:

Pneumococcal Infections

Streptococcal Infections

Gram-Positive Bacterial Infections

Bacterial Infections

Health condition keyword:

VCN7-T

Intervention(s):

Patients from 1 to 18 years of age, belonging to risk groups for pneumococcal disease in the province of Havana. Experimental group (VCNT-7): The Heptavalent Conjugate Vaccine against Pneumococci (VCN7-T), conjugated to tetanus toxoid as a carrier protein, contains the 7 most prevalent serotypes worldwide, in the required doses of the different serotypes: 2.2 μg for serotypes 1, 5, 14, 18C, 19F and 23F, and 4.4 μg for serotype 6B; In America they represent more than 70% of the isolated serotypes. Children from 12 months to 23 months of age: Two doses will be administered, in a volume of 0.5 mL, by intramuscular route (deltoid), with an interval of 8 weeks between doses. Subjects from 2 years to 18 years of age: A single dose will be administered, in a volume of 0.5 mL, by intramuscular route (deltoid).

Intervention code:

Heptavalent Pneumococcal Conjugate Vaccine

Pneumococcal Vaccines

Injections, Intramuscular

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.Proportion of adverse events attributable to vaccination with VCN7-T 30 days after each dose (Frequency and proportion of adverse events reported after the application of each dose of the evaluated schemes). Measurement time: From inoculation until the following 30 days. 2.Proportion of solicited adverse events attributable to vaccination with VCN7-T up to 7 days after administration of each dose (Frequency and proportion of adverse events reported after the application of each dose of the evaluated schemes). Measurement time: From inoculation until the following 7 days.

Key secondary outcomes:

1. Cumulative incidence of pneumonia and IPD cases (Rates of pneumonia and IPD recorded after immunization). Measurement time: From inoculation until the following 2 years. 2.Percentage of subjects in the subgroup studied, with an immune response to the vaccine serotypes (Stratified randomization by age and underlying diseases most representative in the sample; sampling of 5 ml of blood pre- and post-vaccination from a subgroup of 200 subjects). Measurement time: T0 (before inoculation of the vaccine candidate); T28 (28 days after inoculation of the vaccine candidate).

Selection criterias

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

Gender:

Male/Female

Minimum age:

1 year

Maximum age:

18 years

Inclusion criteria:

1. Patients from 1 to 18 years of age included in the risk groups defined in the health areas of the province of Havana. 2. Informed consent of parents and assent of adolescents for vaccination and follow-up.

Exclusion criteria:

1. Previous pneumococcal vaccination. 2. Allergy related to thiomersal, or any biological product or vaccines with a serious adverse reaction such as anaphylaxis. 3. Decompensation of the underlying disease at the time of evaluation. 4. Acute febrile or infectious illness at the time of application of the vaccine candidate, or in the previous 7 days. 5. Have been vaccinated according to the Cuban immunization schedule, in a period of less than 15 days prior to the application of the investigational product. 6. Pregnancy or amenorrhea greater than 4 weeks before the application of the vaccine candidate.

Type of population:

Children

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Prevention

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

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:

Narciso

Middle Name:

Argelio

Last Name:

Jimenez Perez

Specialty:

Internal Medicine Second Degree Specialist. Master in Epidemiology

Affiliation:

Finlay Vaccine Institute (FVI)

Postal Address:

21 Ave., between 198 and 200, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72718331

Email :

njimenez@finlay.edu.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:

Meiby

Middle Name:

de la Caridad

Last Name:

Rodriguez Gonzalez

Specialty:

MGI First Grade Specialist. Master in Epidemiology

Affiliation:

Finlay Vaccine Institute (FVI)

Postal Address:

21 Ave., between 198 and 200, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72717389

Email :

mcrodriguez@finlay.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

“Juan Manuel Marquez” pediatric teaching hospital (centralized)

Status of evaluation:

In review

Status of evaluation date of Ethic Committee:

18/09/2023

Postal address of Ethic Committee :

Ave. 31, Esquina a 76, Marianao, Havana, Cuba. ZC: 11500

Telephone:

+53-52736082

Correo electrónico:

mavaldes@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

07/11/2025

Date of available results:

11/03/2027

Date of first publication:

17/11/2027

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:

RPCEC00000432

Date of Registration in Primary Registry:

04/10/2023

Record Verification Date:

2023/10/04

Next update date:

2024/10/04

Link to the spanish version:

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Phase III study of the Cuban vaccine candidate VCN7-T in patients from 1 to 18 years of age at risk of pneumococcal disease in Havana

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