Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Sponsor:
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier:
NCT01889836
First received: June 10, 2013
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

Clinical trial phase I, randomized, double blind, where 30 individuals will receive the experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate vaccine already licensed in Brazil and available in the National Immunization Program for children less than 12 months of age. The primary outcome of the study is to evaluate the safety profile of the vaccine under test, which should allow its application in humans. Secondly, the investigators will study its immunogenicity from the evaluation of the correlates of seroprotection for meningococcal, defined by the World Health Organization (WHO).


Condition Intervention Phase
Meningitis, Meningococcal, Serogroup C
Biological: 'MenCC-Bio'
Biological: MENJUGATE
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Brazil's Conjugated Vaccine Project Against Meningococcal C. Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos

Resource links provided by NLM:


Further study details as provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):

Primary Outcome Measures:
  • Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans. [ Time Frame: Adverse events post vaccination will be evaluated on days 1,3, 10 and 15 by phone call and on days 2, 7 and 30 at the research center ] [ Designated as safety issue: Yes ]
    To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination.


Secondary Outcome Measures:
  • To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults. [ Time Frame: Blood collection 30 days after vaccination ] [ Designated as safety issue: Yes ]
    30 days after vaccination, blood sampling will be conducted which composes for serological analysis of immunogenicity.


Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenCC-Bio
The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.
Biological: 'MenCC-Bio'
The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.
Active Comparator: MENJUGATE®
The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE®.
Biological: MENJUGATE
The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE.

Detailed Description:

Study design - This is a clinical study Phase I, randomized, double blind with 60 individuals. 30 individuals will receive the experimental vaccine by Bio-Manguinhos/Fiocruz and 30 individuals will receive a meningococcal C conjugated vaccine used in the National Immunization Program.

Location of Study - Clinical Trials Unit for Immunobiology by Bio-Manguinhos/Fiocruz.

Primary objective - Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans.

Secondary objective - To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults.

specific objectives

  1. To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination.
  2. To evaluate the seroconversion defined as pre-immunization serum nonreactive (negative) and post-immunization reactor (positive) antigens, with getting titles 8 (rabbit complement) to the target strain used in the test of bactericidal power of the sera from immunized volunteers, a 4-fold increase in titers following vaccination compared to pre-vaccination and antibody titers after immunization.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both sexes.
  • Age between 18 and 50.
  • Available for follow-up during the period of the study
  • Willing to provide their name, address, telephone number and other information by each they can be contact for the study learn if necessary (eg in case of lack the scheduled visit).
  • Willing to strictly follow the study protocol.
  • Ability to understand and signing the consent form.
  • Understanding the impossibility to participate in another clinical trial during the time which is participating in the study.
  • Intellectual level that allows filling in the forms for registration of symptoms at home.
  • Acceptance for serological testing for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV).
  • Be in good health, with no significant medical history.
  • Physical examination screening without significant clinical changes.
  • Screening laboratory tests within normal limits established the laboratory or abnormal values ​​smaller than 1 degree.
  • Additional criterion for females: Negative pregnancy test before application of the vaccine dose, for women of childbearing age.

Exclusion Criteria:

- Pregnant or breast-feeding.

Personal history of:

  • Meningitis of any kind.
  • Serious adverse reaction to any vaccination, such as difficulty breathing, angioedema and anaphylaxis.
  • Severe adverse reaction related to prior immunization with tetanus and / or diphtheria vaccines alone or in combination vaccines.
  • Vaccination with tetanus and diphtheria vaccines alone or in combinations vaccine in the last two years.
  • Use of allergy shots antigens within 14 days or less prior to vaccination.
  • Immunoglobulin in the last 12 months before vaccination.
  • Use of blood products in the last 12 months before vaccination.
  • Use of any vaccine 30 days before vaccination.
  • Chronic use of any medication except homeopathic and trivial as Nasal saline and vitamins.
  • Previous use of cytotoxic or immunosuppressive medication. Are acceptable individuals who have made use of this type of immunosuppressive medication in doses not more than six months, such as nasal steroids for allergic rhinitis or dermatitis to topical corticosteroid uncomplicated.
  • Use of any investigational medication over a period of 1 year prior to vaccination.
  • Unstable asthma or has required urgent care, hospitalization or intubation in the last two years, or requiring use of oral or intravenous corticosteroids.
  • Severe anaphylaxis or angioedema.
  • Neurological, cardiovascular, respiratory, hepatic, renal, hematologic, rheumatologic or autoimmune clinically significant (diseases that have led to hospitalization or prolonged treatment).
  • Coagulopathy diagnosed by a medical report or capillary fragility (eg bruising or bleeding without justifiable cause).
  • Seizures, except that they have been fever, before 2 years of age.
  • Psychiatric illness that impairs adherence to protocol, such as psychoses, neuroses obsessive-compulsive disorder, bipolar disorder being treated, diseases requiring lithium treatment and suicidal ideation in the last five years prior to enrollment.
  • Active malignancy (eg any type of cancer) or treated to recourse during the study.
  • Sickle cell anemia.
  • Asplenia (or absence of spleen removal of same).
  • HIV positive in the screening test or history of any immunosuppressive disease.
  • Positive serology for hepatitis C screening test.
  • HBsAg positive in the screening test.
  • Alcoholism (CAGE criterion), used for detection of abusive drinkers and alcoholics, validated in our population with a sensitivity of 88% and specificity of 83% if two or more responses among four possible, are affirmative.
  • Use / abuse of drugs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889836

Contacts
Contact: Celia MC Marques, MD 55 21 3882 7062 celia.menezes@bio.fiocruz.br
Contact: Tatiana Guimarães de Noronha, MsD 55 21 3882 7161 tnoronha@bio.fiocruz.br

Locations
Brazil
Unidade de Ensaios Clínicos para Imunobiológicos Not yet recruiting
Rio de janeiro, Rio de janeiro/RJ, Brazil, 21040-360
Contact: Celia MC Marques, MD    55 21 3882 7062    celia.menezes@bio.fiocruz.br   
Contact: Tatiana Guimarães de Noronha, MsD    55 21 3882 7161    tnoronha@bio.fiocruz.br   
Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Investigators
Principal Investigator: Tatiana Guimarães de Noronha, MsD The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
  More Information

No publications provided

Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT01889836     History of Changes
Other Study ID Numbers: ASCLIN / 001 / 2013
Study First Received: June 10, 2013
Last Updated: January 31, 2014
Health Authority: Brazil: National Health Surveillance Agency
Brazil: National Committee of Ethics in Research
Brazil: Ethics Committee

Keywords provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):
meningococcal conjugate vaccine serogroup C
Prevention

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningitis, Bacterial
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on July 22, 2014