Measles Clinical Trial
— MATVACOfficial title:
Specific and Non-specific Effects of Measles and BCG Vaccines for Mother and Child
In Africa, the mortality from infectious diseases remains high. The investigators have discovered that live vaccines such as the BCG vaccine against tuberculosis and the measles vaccine can strengthen resistance to other infections: they have beneficial "non-specific effects". The investigators have now seen signs that these non-specific effects for children are stronger if their mother has been given the same vaccines. In Africa, BCG vaccine is recommended at birth and measles vaccine at 9 months of age. They are not used beyond childhood. The investigators will randomize 2400 women to BCG vaccine, measles vaccine, or placebo. The investigators will further randomize their children to an extra early measles vaccine or placebo. The investigators will assess which of the resulting six vaccination schedules are best for women's and children's protection against measles, for the child's immune system, and for general health. The project will be the first in the world to investigate the importance of vaccinating women with live vaccines.
Status | Recruiting |
Enrollment | 2400 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 35 Years |
Eligibility | Inclusion Criteria: - Female women in the fertile age - Non-pregnant - HIV-negative - Living in the BHP HDSS study area - Delivered a child that has reached 12 months of age - Currently not using contraceptives. Exclusion Criteria: - Positive pregnancy test - Positive HIV test - Tuberculosis (previous or current) - Immunodeficiency - Cancer within the last 2 years - Mid-upper-arm-circumference<200 - Acute ongoing infection |
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | Bandim Health Project | Bissau | Bissau Codex |
Lead Sponsor | Collaborator |
---|---|
Bandim Health Project | The University of Western Australia, Université Libre de Bruxelles |
Guinea-Bissau,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children with maternal measles antibody | Children with maternal measles antibody | 20 weeks of age | |
Primary | Proportion of children with maternal measles antibody | Children with maternal measles antibody | 9 months of age | |
Primary | Yellow fever viral load after yellow fever vaccine | The level of yellow fever virus in the blood following yellow fever vaccine | 9 months of age | |
Secondary | Measles antibody levels in the women | Measles antibody levels in the women | 4 weeks after MV or BCG vaccine | |
Secondary | Measles antibody levels in children | Measles antibody levels in the children | 13.5 months of age | |
Secondary | Incidence of morbidity in women after MV or BCG compared with placebo | Diseases occurring post-randomisation in women | Up to 12 months following vaccination | |
Secondary | Incidence of morbidity in children subsequently born to BCG, MV or placebo vaccinated mothers | Diseases occurring in children of randomised women | Up to age 13.5 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04183114 -
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
|
Phase 2/Phase 3 | |
Completed |
NCT00092430 -
Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)
|
Phase 3 | |
Completed |
NCT02196285 -
Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella
|
Phase 1 | |
Completed |
NCT00384397 -
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
|
Phase 3 | |
Completed |
NCT00313950 -
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
|
Phase 4 | |
Completed |
NCT00402831 -
ProQuad® Intramuscular vs Subcutaneous
|
Phase 3 | |
Completed |
NCT00560755 -
Safety Study of ProQuad® rHA in Infants (V221-037)
|
Phase 3 | |
Completed |
NCT01878435 -
Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
|
N/A | |
Completed |
NCT01777529 -
Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations
|
Phase 4 | |
Terminated |
NCT00258726 -
Immune Responses to Two Dose Varivax +/- MMR-II
|
Phase 1/Phase 2 | |
Completed |
NCT00109278 -
A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
|
Phase 2 | |
Not yet recruiting |
NCT05771779 -
Co-administration Study of OCV, TCV and MR
|
Phase 3 | |
Completed |
NCT02880865 -
Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
|
Phase 4 | |
Completed |
NCT01681992 -
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
|
Phase 3 | |
Completed |
NCT00751348 -
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
|
Phase 3 | |
Completed |
NCT01702428 -
Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
|
Phase 3 | |
Completed |
NCT00969436 -
Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
|
Phase 3 | |
Completed |
NCT00566527 -
Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)
|
Phase 3 | |
Completed |
NCT00127010 -
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
|
Phase 3 | |
Completed |
NCT00388440 -
Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.
|
Phase 4 |