Meningitis, Meningococcal, Serogroup CPhase 1NCT01889836
Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos
A Phase 1 study testing 'MenCC-Bio' and MENJUGATE in people with Meningitis, Meningococcal, Serogroup C, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal, Serogroup C
- What is being tested?
- 'MenCC-Bio' and MENJUGATE
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Unidade de Ensaios Clínicos para Imunobiológicos
Rio de Janeiro, Rio de janeiro/RJ, 21040-360
About this study
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
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).
Read the 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
- To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination.
- 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.
- Conditions
- Meningitis, Meningococcal, Serogroup C
- Being tested
- 'MenCC-Bio', MENJUGATE
- Keywords
- meningococcal conjugate vaccine serogroup C, Prevention
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'MenCC-Bio'Biological
The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.
MENJUGATEBiological
The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE.
| Study group | Role | What they receive |
|---|---|---|
| MenCC-Bio | Experimental | The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos. Receives: Biological: 'MenCC-Bio' |
| MENJUGATE® | Active comparator | The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE®. Receives: Biological: MENJUGATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
30 days after vaccination, blood sampling will be conducted which composes for serological analysis of immunogenicity.
Measured: Blood collection 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, Meningococcal, Serogroup CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatiana Guimarães de Noronha, MsD, Principal investigator, The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889836
- Sponsor's protocol ID
- ASCLIN / 001 / 2013
- Status last verified
- Sep 2015
- First submitted
- 10 Jun 2013
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01889836
- Acronym / sponsor ID
- ASCLIN / 001 / 2013
- Conditions
- Meningitis, Meningococcal, Serogroup C
- Keywords
- meningococcal conjugate vaccine serogroup C, Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MenCC-Bio | Experimental | Biological: 'MenCC-Bio'The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos. |
| MENJUGATE® | Active comparator | Biological: MENJUGATEThe control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE®. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (27 listed)
- Pregnant or breast-feeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'MenCC-Bio'The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos. | Biological | MenCC-Bio |
| MENJUGATEThe control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE. | Biological | MENJUGATE® |
Primary outcome
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
To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination.
1 secondary outcome
To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults.
Time frame: Blood collection 30 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Guimarães de Noronha, MsD principal investigator
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 'MenCC-Bio' and MENJUGATE in people with Meningitis, Meningococcal, Serogroup C, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2015.