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

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.

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.

Study Overview

• Status: Completed
• Conditions: Measles; Rubella
• Intervention / Treatment: Biological: Measles and Rubella vaccine; Biological: Measles, Mumps and Rubella vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040900
    • Secretaria Municipal de Saúde do Estado do Rio de Janeiro
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59.025-050
      • Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda (CPCLIN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 months to 11 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Collaborators: Oswaldo Cruz Institute
• Investigators: Principal Investigator: Kleber G Luz, PhD, Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): August 12, 2020
• Study Completion (Actual): August 12, 2020

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Double Viral Vaccine Measles and Rubella; Safety Efficacy Imunogenicity
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Togaviridae Infections; Rubivirus Infections; Measles; Rubella; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: ASCLIN 002/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No