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Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella (BIOMR)

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ClinicalTrials.gov Identifier: NCT03148990
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Oswaldo Cruz Institute
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Brief 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. This is a Phase I-III, Controlled, randomized and double blind for the evaluation 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. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 11 months in total.

Condition or disease Intervention/treatment Phase
Rubella Measles Biological: Measles and Rubella vaccine Biological: Measles, Mumps and Rubella vaccine Phase 2 Phase 3

Detailed Description:
This is a Phase II-III, controlled, randomized and double blind for the evaluation of a double viral vaccine anti measles and rubella (MR), which is under the development at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and immunogenicity. The study will last 11 months in total.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two intervention groups (MR vaccine and MMR vaccine), with 1 dose of vaccine in each group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II / III, Clinical Trial to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella, Produced by Bio-Manguinhos / Fiocruz in 11-month-old Infants.
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Mumps Rubella

Arm Intervention/treatment
Experimental: Measles and Rubella vaccine
Biological/Vaccine: Administration of the experimental vaccine (Measles and Rubella).
Biological: Measles and Rubella vaccine
Administration of the experimental vaccine (MR).

Active Comparator: Measles, Mumps and Rubella vaccine
Biological/Vaccine: Administration of the comparator vaccine (Measles, Mumps and Rubella).
Biological: Measles, Mumps and Rubella vaccine
Administration of the comparator vaccine (MMR).




Primary Outcome Measures :
  1. Immunogenicity analysis of the study vaccine [ Time Frame: 42 days after the 1st dose of MR or MMR ]
    To evaluate imune response between post and pre-vaccination antibodies.


Secondary Outcome Measures :
  1. Reatogenicity analysis of the study vaccine [ Time Frame: 30 days after the 1st dose of MR or MMR ]
    To assess the occurrence of serious adverse events among individuals who received MR and MMR vaccines.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   11 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both sex;
  • Good health (no significant medical history);
  • 11 months of age on the first dose of vaccine;
  • To be up-to-date with the national vaccination calendar;
  • Availability for follow-up throughout the study period;
  • 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;
  • At least one legal guardian of the research participants must be able to understand and sign the informed consent form;
  • Legal guardians by the research participants who can understand the child's inability to participate in another clinical trial during the time they are participating in the study;
  • Legal guardian with intellectual capacity to fill out the signs of signs and symptoms at home.

Exclusion Criteria:

  • Previous vaccination against measles and rubella;
  • Personal history of measles or rubella;
  • Personal history of anaphylactic shock, asthma, urticaria or other hypersensitivity reaction to previous vaccinations, or who are allergic or hypersensitive to vaccine components of the study;
  • Use of antiallergic injections with antigens within 14 days or less prior to vaccination;
  • Use of immunoglobulin in the last 12 months prior to vaccination;
  • Use of blood products in the last 12 months prior to vaccination;
  • Use of any type of vaccine less than 30 days prior to study vaccination;
  • Use of injectable vaccines less than 42 days after study vaccination;
  • Chronic use of any medications (except homeopathic medicines and trivial medication such as saline and vitamins);
  • Previous use of immunosuppressive or cytotoxic medication;
  • Use of systemic therapy with high doses of steroids;
  • Use of any type of medication in a clinical trial within 12 months prior to vaccination;
  • Personal history of clinically significant neurological, cardiovascular, respiratory, hepatic, renal, haematological, rheumatologic or autoimmune diseases;
  • Personal history of coagulopathies diagnosed by a physician or report of capillary fragility;
  • Personal history of seizures;
  • Personal history of an active (eg any cancer) or treated malignant disease that may recur during the study;
  • Personal history of sickle cell anemia;
  • Asplenia (absence of spleen or removal of the spleen);
  • HIV positive or history of any immunosuppressive disease;
  • Presence of any disorder which, in the opinion of the principal investigator, may interfere with the evaluation of the study objectives;
  • Legal guardian with limited capacity for adherence to the study, according to the researcher's evaluation;
  • Impossibility of blood collection for pre-vaccine evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148990


Contacts
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Contact: Kleber G Luz, PhD +552132327948 ext 4204 klebergluz@gmail.com

Locations
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Brazil
Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda (CPCLIN) Not yet recruiting
Natal, Rio Grande Do Norte, Brazil, 59.025-050
Contact: Eveline Milan P Milan, PhD    +558432327948 ext 4204    evepipolo@gmail.com   
Secretaria Municipal de Saúde do Estado do Rio de Janeiro Recruiting
Rio de Janeiro, Brazil, 21040900
Contact: Tania CMB Petraglia, MD    + 55 21 38827161 ext 7161    taniapetraglia@gmail.com   
Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Oswaldo Cruz Institute
Investigators
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Principal Investigator: Kleber G Luz, PhD Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

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Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT03148990     History of Changes
Other Study ID Numbers: ASCLIN 002/2017
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):
Double Viral Vaccine Measles and Rubella
Safety Efficacy Imunogenicity
Additional relevant MeSH terms:
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Measles
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs