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

NCT01889836 | Completed Phase 1 DMC

• 1 other identifier: ASCLIN / 001 / 2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Meningitis, Meningococcal, Serogroup C

Keywords

meningococcal conjugate vaccine serogroup C; Prevention

Outcome Measures

Primary Outcomes (1)

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

  To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination.

  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

Secondary Outcomes (1)

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

  Blood collection 30 days after vaccination

Study Arms (2)

MenCC-Bio

EXPERIMENTAL

The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.

Biological: 'MenCC-Bio'

MENJUGATE®

ACTIVE COMPARATOR

The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE®.

Biological: MENJUGATE

Interventions

'MenCC-Bio' BIOLOGICAL

The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.

MenCC-Bio

MENJUGATE BIOLOGICAL

The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE.

MENJUGATE®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead

Study Sites (1)

Unidade de Ensaios Clínicos para Imunobiológicos

Rio de Janeiro, Rio de janeiro/RJ, 21040-360, Brazil

Location

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Tatiana Guimarães de Noronha, MsD

  The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: July 1, 2013
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

BR (1)