Safety and immunogenicity of VCN7-T in infants of 2 and 3 months. Phase I/II.

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:

SILAC

Scientific title:

Evaluation of the safety and immunogenicity of the pentavalent vaccine candidate against pneumococcus (VCN7-T) in different administration regimens to infants. Phase I/II”.

Acronym of Scientific Title:

SILAC

Secondary indentifying numbers:

IFV/NEU/04

Issuing authority of the secondary identifying numbers:

Finlay Institute Vaccine

Source(s) of monetary or material support:

Finlay Institute Vaccine

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:

Maria

Midle name:

Eugenia

Last name:

Toledo Romani

Medical Specialty :

First degree Specialist in Integral General Medicine

Affiliation:

Institute of Tropical Medicine "Pedro Kouri"

Postal address:

Highway Novia del Mediodia. No. Km 6½. Arroyo Arenas

City:

Havana

Country:

Cuba

Zip Code:

11500

Telephone:

+53-772020427

Email address:

mariaeugenia@ipk.sld.cu [1]

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, Marianao, "Finlay" Policlinic, Lorenzo de la Rosa Ocampo, MD, First degree specialist in Pediatrics.

Havana, Marianao, "Ramon Gonzalez Coro" Policlinic, Belkys Bonet Boza, MD, First degree specialist in pediatrics.

Havana, Playa, "26 de Julio" Policlinico, Yamile Fernández González , MD, First degree Specialist in Pediatrics.

Havana, Playa,"5 de Septiembre" Polyclinic, Maria Elena Pupo Tejeda, MD, First degree specialist in Pediatrics.

Havana, Playa, "1 de Enero" Polyclinic, Xiomara Ríos Pérez, MD, First degree specialist in pediatrics.

Havana, Playa, "Isidro de Armas" Polyclinic, Yamilet Castro Avila, MD, First degree specialist in General Medicine.

Havana, Lisa, "Aleida Fernández" Policlinic, Gladys Maria Lopez del Rosario , MD, First degree Specialist in Pediatrics.

Havana, Lisa, "Elpidio Berovides" Policlinic, Maria de L. Ortiz Hernandez , MD, First degree Specialist in Pediatrics

Havana, Lisa, "Pulido Humaran" Policlinic, Ernesto Rafael Gutierrez Mendoza , MD, First degree Specialist in Pediatrics

Havana, Marianao, Pediatric Hospital Juan Manuel Marquez, Carlos Pablo Dotres Martinez, MD, Specialist II degree in Pediatrics

Research ethics committees:

Juan Manuel Marquez Teaching Pediatric Hospital, in review

Institute of Tropical Medicine "Pedro Kouri", in review

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

24/05/2017

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 disease

Health condition(s) code:

Healthy Volunteers

Pneumococcal Infections

Streptococcal Infections

Gram-Positive Bacterial Infections

Health condition keyword:

Intervention(s):

Group 1 (Experimental). Intervention 2p + 1, VCN7-T with outdated VA-MENGO-BC® vaccine, 2 doses of VCN7-T with an 8-week interval, by intramuscular route on the anterolateral left thigh, administered at 3 and 5 months, 1 Dose of VCN7-T administered at 12 months of age. Group 2 (Experimental). Intervention 2p + 1, VCN7-T, concomitant with the VA-MENGO-BC® vaccine, 2 doses of VCN7-T with an 8-week interval, by intramuscular route on the anterolateral left thigh, administered at 3 and 5 months, VA-MENGO-BC® vaccine will be administered concomitantly on the anterolateral aspect of the right thigh, 1 dose of VCN7-T administered at 12 months of age. Group 3 (Control). Intervention 2p + 1, Prevnar 13 ® with outdated VA-MENGO-BC® vaccine, 2 doses of Prevnar 13® with an 8-week interval, by intramuscular route on the anterolateral left thigh, administered at 3 and 5 months, 1 Dose of Prevnar 13 ® administered at 12 months of age. Group 4 (Control). Intervention 2p + 1, Prevnar 13 ® with the concomitant VA-MENGO-BC® vaccine, 2 doses of Prevnar 13® with an 8-week interval, by intramuscular route on the anterolateral left thigh, administered at 3 and 5 months, VA-MENGO-BC® vaccine will be administered concomitantly on the anterolateral aspect of the right thigh, 1 dose of Prevnar 13 ® administered at 12 months of age. Group 5 (Experimental). Intervention 3p + 0, VCN7-T concomitant with Heberpenta®, 3 doses of VCN7-T with interval of 8 weeks, by intramuscular route on the anterolateral side of the left thigh, administered at 2, 4 and 6 months. Group 6 (Control). Intervention 3p + 0, Prevnar 13 ® concomitant with Heberpenta ®, 3 doses of Prevnar 13 ® with an 8-week interval, by intramuscular route on the anterolateral side of the left thigh, administered at 2,4 and 6 months

Intervention code:

Heptavalent Pneumococcal Conjugate Vaccine

Vaccines, Conjugate

Intervention keyword:

Vacuna Va-Mengoc-BC® Heberpenta® Prevnar13® VCN7-T

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):

Phase I: Safety Adverse event (AE). Measuring time: 3 hour after each immunization and at 24, 48, 72 hours, 7,15, 21 and 30 days. The AD will be measured like: - Description of the expected AE (Nominal. Any sign or symptom that appears after the vaccination and 30 days before it is declared as AE expected). - Description of the unexpected AE (Nominal. Any signs or symptoms that appear after the before vaccination and 30 days is not expected within the AE). - Duration of AE (Ordinal. <= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours) - Emergence of AE (Ordinal. <= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours) - Intensity of AE (Ordinal. mild, moderate, severe) - Severity of AE (Nominal. Grave / Serious, not serious) - Results of AE (Nominal. recovered, recovered with sequelae, persistence, death or unknowns). - Causal relationship (Nominal. Causal association consistent with vaccination, Undetermined, Causal association inconsistent) Phase II: Immunogenicity 1. Anti-PsC antibody concentration of the seven common serotypes between VCN7-T and Prevnar 13® (Continuous. From the quantification limit (0.15 μg / mL) to the maximum concentration Quantified by the method (ELISA). Subjects reaching concentration ≥ 0.35 μg / mL). Measuring time: after the completion of the vaccination . 2. Anti-Psi antibodies index of the seven common serotypes between VCN7-T and Prevnar 13® (Continuous. From the minimum dilution (1: 4) to the maximum serum dilution causing a 50% death Bacterial (opsonophagocytosis assay). Subjects reaching opsonophagocytic index ≥ 8). Measuring time: after the completion of the vaccination .

Key secondary outcomes:

Nasopharyngeal carrier status (nasopharyngeal exudate to explore changes in carrier status and determine circulating serotypes). Measurement time: baseline and, after the completion of the vaccination .

Selection criterias

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

Gender:

Male/Female

Minimum age:

2 months

Maximum age:

3 months

Inclusion criteria:

1. Infants whose parents or legal guardians sign the Informed Consent. 2. Infant of 2 and 3 months of age after questioning and physical examination practiced by the Clinical Investigator. 3. Weight-height nutritional assessment above the 10th percentile. 4. Birth weight greater than or equal to 2500 grams. 5. Apgar equal or greater than 7 at birth and equal or greater than 8 at five minutes of birth. 6. Maternal gestational age equal to or greater than 37 weeks at the time of delivery.

Exclusion criteria:

1. Infectious diseases at moment of vaccination or 7 days before vaccination. 2. Previous use of any investigation product or any product 30 days before vaccination. 3. History of immune suppressor or immune stimulant treatment 30 days before vaccination. 4. History of use of blood products like blood transfusions, plasma, whole blood, platelet concentrate, gamma globulins and transfer factor at any time of lives. 5. History of anaphylaxis reactions related with the use Thiomersal or other pharmaceutical products. 6. History of severe allergic diseases or reactions. 7. History of immunosuppressive, congenital or acquired disease. 8. Infants with febrile convulsions history. 9. Diseases or mayor genetic defects. 10. History of chronic diseases as Asthma Bronquial, Diabetes Mellitus, Epilepsy, Allergic Dermatitis, encephalopathy and others. 11. Immunization with any Streptococcus pneumoniae vaccine. 12. History of vaccination with any vaccine 15 days before the administration of research product. 13. Mother less than 18 years old or mental disability.

Type of population:

Children

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:

1-2

Target sample size:

880

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:

Nivaldo

Last Name:

Linares Perez

Specialty:

2nd Degree Specialist in Epidemiology. PHD.

Affiliation:

Finlay Institute

Postal Address:

Ave. 21 No. 19802 e/ 198 y 200, Atabey, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537-2717389

Email :

nlinares@finlay.edu.cu [2]

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:

Nivaldo

Last Name:

Linares Perez

Specialty:

2nd Degree Specialist in Epidemiolgy. PHD

Affiliation:

Finlay Institute

Postal Address:

Ave. 21 No. 19802 e/ 198 y 200, Atabey, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537 2717389

Email :

nlinares@finlay.edu.cu [2]

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:

RPCEC00000243

Date of Registration in Primary Registry:

28/04/2017

Record Verification Date:

2017/04/28

Next update date:

2018/04/28

Link to the spanish version:

Click here [3]