Study of the meningococcal ACW135 polysaccharide vaccine

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:

ACW135

Scientific title:

Study Phase I-II, controlled, randomized, at double blind, to evaluate the safety, reactogenicity and the immune response, for bactericidal antibodies in serum, of the meningococcal polysaccharide vaccine ACW135, produced by the Institutes Finlay and Bio-Manguinhos/FIOCRUZ, using as control the vaccine MENCEVAX ACW, administered in unique dose in healthy young adults of both sexes.

Secondary indentifying numbers:

IF/MENINGO ACW/1

Issuing authority of the secondary identifying numbers:

Finlay Institute

Source(s) of monetary or material support:

Finlay Institute, Center for Research and Productions of Serum and Vaccines.

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 the Quality of Drugs(CECMED)

Authorization date :

15/05/2011

Reference number:

05.06.11.B

Principal investigator

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

First name:

Belkis

Midle name:

Aracelis

Last name:

Barrera-Suarez

Medical Specialty :

First degree Specialist in General Integral Medicine. Master on Epidemiology

Affiliation:

Ernesto Che Guevara Polyclinic, University of Computer Science

Postal address:

Carretera de San Antonio de los Bannos, Km 2 ½. Boyeros

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-78358208

+53-78358359

Email address:

belkisb@uci.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:

Not applicable

Research ethics committees:

Ethics committee of Investigations of the Victoria de Giron Basic Science and Preclinical Institute, March 12, 2011

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

19/05/2011

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:

Meningococcal Disease, Meningococcal Meningitis

Health condition(s) code:

Meningitis, Meningococcal

Meningococcal Infections

Meningitis, Bacterial

Bacterial Infections

Central Nervous System Bacterial Infections

Central Nervous System Infections

Neisseriaceae Infections

Gram-Negative Bacterial Infections

Health condition keyword:

Meningococcal Infections

Meningococcal Meningitis

Intervention(s):

Group 1 (Experimental): A single dose of 0.5 mL of the MPV ACW135 vaccine by subcutaneous route Group 2 (Control): A single dose of 0.5 mL of the MENCEVAX ACW vaccine by subcutaneous route

Intervention code:

Meningococcal Vaccines

Intervention keyword:

Meningococcal vaccine

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):

Safety: Serious Adverse Events (SAEs) related to the vaccine (anaphylactic reaction, temperature higher than 40oC, hypotension, bronchospasm, glottis edema, convulsions). Measuring time: 1, 2, 3, 4, 5, 6, 7, 15 28 days after vaccination. Reactogenicity: Local Adverse Events (Pain in the injection site, redness in the injection site, induration in the injection site). Measuring time: Day 1,2,3,4,5,6,7, 15 and 28 after vaccination General Adverse Events (Fever, Malaise, Headache and somnolence). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination. Description of the unexpected adverse events (Adverse Event name). Measuring time: 7, 15 and 28 days after the vaccination. Intensity of adverse events (Mild, moderate, or severe). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination. Adverse events with causality relationship (related, unrelated). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination.

Key secondary outcomes:

Immunogenicity - Seroprotection (Bactericidal antibody titers ≥ 1:8). Measuring time: at baseline and 28 days after vaccination. - Bactericidal antibody seroconversion (Increase of at least 4 times the bactericidal antibodies titers). Measuring time: at baseline and 28 days after vaccination. - Bactericidal Antibodies Geometric mean titers in serum samples. Measuring time: at baseline and 28 days after 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:

18 years

Maximum age:

35 years

Inclusion criteria:

1. Healthy adult of both sexes, with ages between 18-35 years old. 2. Good state of physical and mental health established by medical opinion by means of anamnesis and physical exam, before beginning the study. 3. Voluntary nature expressed by means of written informed consent.

Exclusion criteria:

1. Presence of acute disease (with or without fever) previous to the moment of their incorporation to the study. 2. Axilar temperature equal to or higher than 37.5 Celcius degrees immediately before the administration of the treatment. 3. Any suspicious or confirmed condition of immunodeficiency including positive diagnostic of HIV. 4. To have suffered meningococcal disease. 5. Therapy history with immunoglobulin during the 30 previous days to the administration of the vaccines included in the study 6. To be under immunosuppressive treatment (more than 14 days) or another type of medication that modifies the immunologic state, excluding the topical steroids or by inhalation. 7. Administration of a vaccine not planned in the Protocol, 30 days before the beginning of the study. 8. Pregnancy or lactation.

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:

1-2

Target sample size:

352

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:

Belkis

Middle Name:

Aracelis

Last Name:

Barrera-Suarez

Specialty:

First degree specialist of Integral General Medicine. Master on Epidemiology

Affiliation:

Polyclinic Ernesto Che Guevara, University of Computer Sciences

Postal Address:

Carretera San Antonio de los Bannos, Km. 2 ½, Boyeros

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

53-78358208, 5378358359

Email :

belkisb@uci.cu [1]

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:

Rossana

Last Name:

Estruch de la Guardia

Specialty:

First degree specialist in Epidemiology

Affiliation:

Finlay Institute, Center for the Research and Production of Sera and Vaccines.

Postal Address:

Ave 27, No. 19805, La Coronela, Lisa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

53(7)2717911 ext 246

Email :

restruch@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:

RPCEC00000203

Date of Registration in Primary Registry:

04/12/2015

Record Verification Date:

2015/12/04

Next update date:

2016/12/04

Link to the spanish version:

Click here [3]