Clinical Trial with the Outer Membrane Vesicles (OMV) Bivalent AW135 Anti meningocóccal Vacccine Candidate

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.

Scientific title:

Parallel, controlled, randomized, double-blind phase I Clinical Trial to assess the safety and reactogenicity and to explore the immunogenicity of two doses of the Outer Membrane Vesicles (OMV) Bivalent AW135 Antimeningocóccal Vacccine Candidate in healthy adults of both gender

Secondary indentifying numbers:

IF/MENINGO AW/01

Issuing authority of the secondary identifying numbers:

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

Source(s) of monetary or material support:

Program for Global Health and Research on Vaccination (GLOBVAC)

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 :

07/03/2013

Reference number:

05.021.12.B

Principal investigator

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

First name:

Dr. Sonia Pérez Rodríguez specialized in first degree of Internal Medicine

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [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

Research ethics committees:

National Center of Toxicology (CENATOX), October 29th, 2012

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

14/07/2013

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

Intervention(s):

Study group (AW135 Vacccine Candidate): 1 dose de 0,5 mL by intramuscular route in the deltoid deep every 6 weeks. Total: 2 doses. Control group (VAMENGOC BC): 1 dose de 0,5 mL by intramuscular route in the deltoid deep every 6 weeks. Total: 2 doses. Both groups have active vigilante and follow periods Active vigilance period: 7 days after administration of every dose Follow-up period: 30 days after administration of every dose

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):

Severe Adverse Event (name of event and causality relationship). Measuring time: during the 84 days of the study. Laboratory tests (hematology and blood chemistry clinical laboratory tests results with values out of the reference range). Measuring time: 7 days after the firts dose Expected adverse events of grade 3 (name, initial date, duration time). Measuring time: daily during the 7 days after every dose. Expected adverse events of other grade (name, initial date, duration time). Measuring time: daily during the 7 days after every dose. Unexpected adverse events (name, initial date, duration time, grade, causality relationship). Measuring time: during the 84 days of the study.

Key secondary outcomes:

Bactericidal Serum Antibodies against meningococcal strain of the A and W135 serogroup. Measuring time: before administration of every dose, 42 days and 30 days after the administration of every dose. Seroconversion (the increment of at least four fold N. meningitidis Bactericidal Antibodies titer in Serum of the A and W135 serogroups). Measuring time: days 42 and 30 after the administration of every dose. Antibodies concentration against the Outer Membrane Protein antigen. Measuring time: before administration of every dose, at the 42 days and 30 days after the administration of every dose.

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:

50 years

Inclusion criteria:

1.Woman or men from 18 to 50 years old with a body mass index (BMI) between 18 and 29,9. 2.Good physical and mental health state, established by mean of anamnesis and physical examination as a medical criteria, as well by mean of electrocardiogram and hematology, hemochemical and urine tests, within non clinically significant reference parameters, as well as negative results in the serology of VDRL, HIV and HBV surface Ag and HCV before the beginning of the study. 3.Willfulness expressed by mean of a written informed consent.

Exclusion criteria:

1.Occurrence of acute illness (with or without fever) within 30 days prior to the moment the subject be included in the study. 2.Chronic diseases such cancers, diabetes, heart disease, liver disease, progressive neurological disease, autoimmune disease or blood dyscrasias, signs of heart or renal failure or severe malnutrition. 3.Any suspected or confirmed condition of immunodeficiency. 4.To have suffered meningococcal disease. 5.To have been immunized with meningococcal vaccine, 6 months prior to administration of the treatments included in the study. 6.History of immunoglobulin therapy during the 30 days prior to the administration of the treatments included in the clinical trial. 7.To be under immunosuppressive treatment (more than 14 days) or other medication which modify the immune status, excluding topical or inhaled steroids. 8.Administration of a vaccine not predicted in the protocol, 30 days before the beginning of the study. 9.Pregnancy or breastfeeding. 10.Alcoholism defined as set forth in the CENATOX algorithm 11.Allergy to Thiomersal.

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:

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:

Sonia

Last Name:

Perez Rodriguez

Affiliation:

National Center of Toxicology (CENATOX) “Carlos J. Finlay“ Military Hospital, MINSAP, Cuba

Postal Address:

114 street and 31 Avenue, Marianao

City:

Havana

Country:

Cuba

Zip Code:

10699

Telephone:

537-2607821, 537-2601230

Email :

email@not.entered [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:

Rodrigo

Middle Name:

Felipe

Last Name:

Valera Fernández

Affiliation:

Dept. of Clinical Trial, from the Medical Management at the Commercial Vice-presidency of the Finlay Institute

Postal Address:

212 street, number 3112 between 31 and 37 street, La Coronela, La Lisa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

537-2711911 (ext. 278 and 295)

Email :

rvalera@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:

RPCEC00000160

Date of Registration in Primary Registry:

2013-06-19

Record Verification Date:

2013-05-24

Next update date:

2014-05-24

Link to the spanish version:

Click here [3]