A single-center, randomized, single-blind, phase 4 study to evaluate the enhancement of mucosal immunity in infants through maternal vaccination during breastfeeding (MEALAC-01).
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The level of binding antibodies against measles in breastmilk in vaccinated vs unvaccinated mothers, 5 times over 3 months.
Study Overview
Brief Summary
The main objective of this study is to investigate the humoral immune response to MMR vaccination in breastmilk over a 3-month period. This will allow us to determine to which extent a booster MMR dose during lactation can induce more antibodies against measles, as compared to unvaccinated lactating women, and to study the waning of this response over time.
Eligibility Criteria
- Ages
- 0 years to 64 years (0-17 Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 18 and 45 years, healthy
- •Intention to breastfeed for more than 2 months
- •Capable of giving consent for themselves
Exclusion Criteria
- •Inability to understand the nature and extent of the study and the procedures required
- •Blood hemorrhage >500 mL during delivery
- •Acute infection at the time of delivery or in the last 7 days of pregnancy
- •Grade III/IV anaemia
- •Chronic infections such as HBV , HCV or HIV infection; acute toxoplasmosis
- •Current or recent use of immunosuppressive drugs
- •Active neoplasia
- •Twin or triplet pregnancies
- •Infants born before 35 weeks of gestation
- •Infant birthweight below 2.5 kg
- •Infant serious congenital abnormalities or congenital infection
Arms & Interventions
M-M-RvaxPro powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)
Intervention: M-M-RvaxPro powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live) (Drug)
Outcomes
Primary Outcomes
The level of binding antibodies against measles in breastmilk in vaccinated vs unvaccinated mothers, 5 times over 3 months.
The level of binding antibodies against measles in breastmilk in vaccinated vs unvaccinated mothers, 5 times over 3 months.
Secondary Outcomes
- Phenotype and activation of immune cells in breastmilk
Investigators
Arnaud Marchant
Scientific
Universite Libre de Bruxelles