Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella

NCT02196285 | Completed Phase 1 DMC

• 1 other identifier: ASCLIN 002/2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Rubella; Measles

Keywords

Double; Viral; Vaccine; Measles; Rubella; Safety; Efficacy; Imunogenicity

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability analysis of the study vaccine

  To evaluate the occurrence of serious adverse events among the subjects who have received study vaccine.

  9 months

Secondary Outcomes (1)

• Imunogenicity analysis

  9 months

Study Arms (1)

Double viral vaccine (MR)

EXPERIMENTAL

Measles and rubella vaccine

Biological: Double viral (MR) vaccine

Interventions

Double viral (MR) vaccine BIOLOGICAL

Measles and Rubella vaccine, as single arm

Also known as: Measles and Rubella vaccine, MR Vaccine

Double viral vaccine (MR)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;
• 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;

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Unidade de Ensaios Clínicos para Imunobiológicos

Rio de Janeiro, Rio de Janeiro, 21040900, Brazil

Location

MeSH Terms

Conditions

Rubella; Measles

Interventions

Vaccines; Rubella Vaccine; Measles Vaccine

Condition Hierarchy (Ancestors)

Rubivirus Infections; Togaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Viral Vaccines

Study Officials

• Jose CerbinoNeto, PHD

  Unidade de Ensaios Clínicos para Imunobiológicos, Fiocruz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 22, 2014
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

BR (1)