RubellaPhase 1MRNCT02196285
Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella
A Phase 1 study testing Double viral (MR) vaccine in people with Rubella and Measles, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial summary
Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences demonstrate the benefit for providing the universal access to vaccines containing measles and rubella antigens, mainly due to, respectively, mortality in children and malformations in fetuses. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- What is being tested?
- Double viral (MR) vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Mar 2016
- 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age between 18 and 49 years old;
- Willing to provide name, address, telephone and other contact information in order to be contacted, whenever needed (example: in case of missing any scheduled visit, contact for confirmation of scheduling a visit, urgent safety notifications);
- Willing to strictly follow the study protocol;
- Capacity for understanding and signing in the Informed Consent Form;
- To understand the impossibility of participating in another clinical trial during the time of participation in the study, until 6 months after its conclusion;
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- Intellectual level which allows to filling in the diaries for registering of symptoms at home;
- Willing to undergo to serological testing to HIV, HBV and HCV;
- Being in good health, with no significant medical history;
- Physical examination at screening period without clinically significant changes;
- Lab examination at screening period within the normal ranges, determined by the laboratory or abnormal values, grading below 1 or 2, according to medical decision.
Who cannot join
- Serious adverse reaction to any vaccination, as respiratory difficulty, angioedema and anaphylaxis;
- Acute or chronic disease, as diabetes, heart disease, systemic arterial hypertension;
- Use of anti-allergic with antigen injections in a maximum timeline of 14 days before the vaccination;
- Use of immunoglobulin in the past 12 months before the study vaccination;
- Use of blood products within 12 months before the vaccination;
- Use of any vaccine type within 30 days before the vaccination of the study;
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- Chronic use of any medication, except homeopathy, and trivial ones, as nasal physiologic solution and vitamins;
- Previous immunosuppressive or cytotoxic medication, in the last 6 months. Individuals who have made use of this kind of medication in non-immunosuppressant doses, as nasal corticosteroid for allergic rhinitis of topic corticosteroid for non-complicated dermatitis, for more than 14 days, are allowed to be included in the study.
- Use of any kind of medication under investigation within one year before the vaccination.
- Unstable asthma or which may have required urgent care, hospitalization or intubation within the last 2 years, or which requires use of oral or intravenous corticosteroid.
- Coagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises or bleedings without justifiable cause;
- Convulsions, except the ones caused by fever, before 2 years old;
- Psychiatric disease which difficults the adherence to the protocol, such as psychosis, obsessive-compulsive disorders, bipolar disease under treatment, diseases which require treatment with lithium and suicidal ideas in the last 5 years from the inclusion;
- Active malignant (p.e. any kind of cancer) or treated disease, to which the individual may relapse during the study;
- Asplenia (absence of spleen or its removal);
- Positive HIV in the screening examination of history of any immunosuppressant disease;
- Positive serology for C hepatitis in the screening evaluation;
- Positive Antigen HBs in the screening evaluation;
- Alcoholism (CAGE criteria), used for detection of abusive drinkers or alcoholic, validated in the Brazilian population with sensibility of 88% and specificity of 83%, if two or more answers, among four possible, are afirmative(Mansur and Monteiro, 1983), or according to medical decision;
- Abuse of illicit drugs, according to medical decision;
- Acquired or congenital immunodeficiency;
- Allergy to the vaccine compounds, as egg, neomycin and gelatin.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Unidade de Ensaios Clínicos para Imunobiológicos
Rio de Janeiro, Rio de Janeiro, 21040900
About this study
Official title: A Phase I, Open, Uncontrolled Study, to Evaluate the Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella in Young Adults
Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences demonstrate the benefit for providing the universal access to vaccines containing measles and rubella antigens, mainly due to, respectively, mortality in children and malformations in fetuses. This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 20 months in total.
Read the detailed description
This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 20 months in total.
- Being tested
- Double viral (MR) vaccine
- Keywords
- Double, Viral, Vaccine, Measles, Rubella, Safety, Efficacy, Imunogenicity
- Medical subject headings
- Rubella, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double viral (MR) vaccineBiological
Also called Measles and Rubella vaccine, MR Vaccine
Measles and Rubella vaccine, as single arm
| Study group | Role | What they receive |
|---|---|---|
| Double viral vaccine (MR) | Experimental | Measles and rubella vaccine Receives: Biological: Double viral (MR) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability analysis of the study vaccine
To evaluate the occurrence of serious adverse events among the subjects who have received study vaccine.
Measured: 9 months
Secondary outcomes (1)
Imunogenicity analysis
To evaluate imune response between post and pre-vaccination antibodies.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RubellaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Jose CerbinoNeto, PHD, Principal investigator, Unidade de Ensaios Clínicos para Imunobiológicos, Fiocruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196285
- Sponsor's protocol ID
- ASCLIN 002/2014
- Acronym
- MR
- Status last verified
- Jun 2016
- First submitted
- 16 Jul 2014
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open, Uncontrolled Study, to Evaluate the Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella in Young Adults
- ClinicalTrials.gov ID
- NCT02196285
- Acronym / sponsor ID
- MR / ASCLIN 002/2014
- Keywords
- Double, Viral, Vaccine, Measles, Rubella, Safety, Efficacy, Imunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Jul 2014 (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.
Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences demonstrate the benefit for providing the universal access to vaccines containing measles and rubella antigens, mainly due to, respectively, mortality in children and malformations in fetuses. This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 20 months in total.
Detailed description
This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 20 months in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double viral vaccine (MR) | Experimental | Biological: Double viral (MR) vaccineMeasles and rubella vaccine |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male
- Age between 18 and 49 years old;
- Willing to provide name, address, telephone and other contact information in order to be contacted, whenever needed (example: in case of missing any scheduled visit, contact for confirmation of scheduling a visit, urgent safety notifications);
- Willing to strictly follow the study protocol;
- Capacity for understanding and signing in the Informed Consent Form;
Key exclusion criteria (22 listed)
- Serious adverse reaction to any vaccination, as respiratory difficulty, angioedema and anaphylaxis;
- Acute or chronic disease, as diabetes, heart disease, systemic arterial hypertension;
- Use of anti-allergic with antigen injections in a maximum timeline of 14 days before the vaccination;
- Use of immunoglobulin in the past 12 months before the study vaccination;
- Use of blood products within 12 months before the vaccination;
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 |
|---|---|---|
| Double viral (MR) vaccineAlso: Measles and Rubella vaccine, MR VaccineMeasles and Rubella vaccine, as single arm | Biological | Double viral vaccine (MR) |
Primary outcome
Safety and tolerability analysis of the study vaccine
Time frame: 9 months
To evaluate the occurrence of serious adverse events among the subjects who have received study vaccine.
1 secondary outcome
Imunogenicity analysis
Time frame: 9 months
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 22 Jun 2016.
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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.
Jose CerbinoNeto, PHD principal investigator
Unidade de Ensaios Clínicos para Imunobiológicos, 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 Double viral (MR) vaccine in people with Rubella and Measles, 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 11 inclusion and 22 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 22 Jun 2016. 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?
Safety and tolerability analysis of the study vaccine (time frame: 9 months). 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 22 Jun 2016.