Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With MMR (BREMEAVAC)
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| ClinicalTrials.gov Identifier: NCT02325310 |
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Recruitment Status :
Completed
First Posted : December 24, 2014
Last Update Posted : May 1, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Measles Rubella Mumps | Biological: Combined measles-mumps-rubella (MMR) vaccine - PRIORIX® | Phase 4 |
This is a multicentre prospective study, to evaluate the safety of infant from 50 breastfeeding women, analyzable for primary endpoint, after postpartum immunization with MMR vaccine.
During the screening period, eligibility will be determined based on the inclusion and exclusion criteria. Medical records of pregnant women will be screened by study investigators, who will then propose to the woman to participate to the study during a phone call or a follow-up visit. Screening visit could take place 4 months before delivery planned date up until the day of delivery.
The investigator will explain the study to the woman. A copy of the informed consent documents will be given to the woman for reading and for further information about the study (by email, by post, or personally).
If the woman is willing to participate to the study and after she had given her screening informed consent, a blood sample for measles serological analysis will be drawn.
After signing the consent, women meeting all the inclusion criteria and none of the exclusion criteria will be vaccinated in post partum and before the exit of the maternity at day 0.
Each woman will have a blood draw at day 0 and breast milk samples as well as urine samples at the hospital at day 0 before vaccination.
Each included woman will also provide breast milk and urine home samples at days 7, 11 and 14 after vaccination. Reminder calls will be performed at days 7, 11 and 14 after vaccination.
Women will then be followed and vaccinated 8 weeks after the first vaccination, visit V1.
Each infant will be followed during 8 weeks. An optional blood sample for immunological analysis will be drawn at week 8 (visit v1). Informed consent form signed by the person(s) holding parental authority (both parents or mother only if the father has no parental authority) is needed for the infant to be included as well.
Diary cards will be used to follow the infant and the mother. If Infant and/or mother develop(s) suspected measles symptom(s), they will be evaluated by a study physician as soon as possible, preferably within 24 to 72 hours of acute measles symptom(s) onset.
In case of mother symptoms, infant will be also seen by a physician during mother's supplementary visit.
The visit at day 0 (V0) of the study will be performed at the maternity. The other visits, screening visit, V1 and supplementary visit (SV), will be performed either at the maternity or at the corresponding CIC if applicable. Home samples at 7, 11 and 14 days after vaccination will be directly sent at the laboratory of virology at Limoges. Home sampling can also be performed at the maternity or CIC according to their internal organization.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With a Combined Measles-mumps-rubella (MMR) Vaccine |
| Actual Study Start Date : | February 4, 2015 |
| Actual Primary Completion Date : | May 3, 2016 |
| Actual Study Completion Date : | November 1, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Breastfeeding women
70 breastfeeding women meeting all the inclusion criteria and none of the exclusion criteria will be immunized with MMR vaccine in postpartum (before the exit of the maternity)
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Biological: Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®
One dose of 0.5 mL vaccine will be administered (intra-muscularly or subcutaneous) in post-partum (before the exit of the maternity) during visit V0. A second dose will be administered at week 8(+/-15 days) during visit V1. |
- Prevalence of the measles vaccine virus strain in breast milk. [ Time Frame: day 7 after the first vaccination. ]Number of women with positive RT-PCR for measles vaccine virus strain in breast milk for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
- Prevalence of the measles vaccine virus strain in breast milk. [ Time Frame: day 11 after the first vaccination. ]Number of women with positive RT-PCR for measles vaccine virus strain in breast milk for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
- Prevalence of the measles vaccine virus strain in breast milk. [ Time Frame: day 14 after the first vaccination. ]Number of women with positive RT-PCR for measles vaccine virus strain in breast milk for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
- Number of infants with reported clinical symptoms of measles [ Time Frame: At V1 Visit (8 weeks +/- 15 days) ]Evaluation of the clinical impact of MMR vaccination in breastfeeding infant
- Number of infants with reported clinical symptoms of measles [ Time Frame: Between V0 visit and V1 visit (8 weeks +/- 15 days) after the first MMR vaccination ]Evaluation of the clinical impact of MMR vaccination in breastfeeding infant from data reported in the infant diary card (DiCa).
- Number of women with reported clinical symptoms of measles [ Time Frame: V1 Visit (8 weeks +/- 15 days) after the first MMR vaccination ]Evaluation of the clinical impact of MMR vaccination in breastfeeding infant from mother clinical data
- Number of women with reported clinical symptoms of measles [ Time Frame: Between V0 visit and V1 visit (8 weeks +/- 15 days) after the first MMR vaccination ]Evaluation of the clinical impact of MMR vaccination in breastfeeding infant from mother clinical data repoted in the diary card (DiCa).
- Number of infants with positive measles serology (IgM) [ Time Frame: V1 visit (8 weeks +/- 15 days) after the first MMR vaccination ]Evaluation of the immunological impact of MMR vaccination in breastfeeding infant.
- Number of women with positive RT-PCR for measles vaccine virus strain in urine in at least one sample [ Time Frame: At day 7 after the first vaccination. ]For detection of measles vaccine strain excretion in urine of breastfeeding women, the number of women, with negative rubella and measles serologies with positive RT-PCR for measles vaccine virus strain in urine for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine will be assessed. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
- Number of women with positive RT-PCR for measles vaccine virus strain in urine in at least one sample [ Time Frame: At day 11 after the first vaccination. ]For detection of measles vaccine strain excretion in urine of breastfeeding women, the number of women, with negative rubella and measles serologies with positive RT-PCR for measles vaccine virus strain in urine for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine will be assessed. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
- Number of women with positive RT-PCR for measles vaccine virus strain in urine in at least one sample [ Time Frame: At day 14 after the first vaccination. ]For detection of measles vaccine strain excretion in urine of breastfeeding women, the number of women, with negative rubella and measles serologies with positive RT-PCR for measles vaccine virus strain in urine for at least one sample from day 7, 11 and 14 after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine will be assessed. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
- Quantification of the measles vaccine virus strain presented in breast milk in at least one sample [ Time Frame: At day 7 after the first vaccination. ]In case of detection of measles vaccine virus strain excretion in breast milk, RT-PCR quantification measure of measles vaccine virus strain in woman breastmilk will be performed.
- Quantification of the measles vaccine virus strain presented in breast milk in at least one sample [ Time Frame: At day 11 after the first vaccination. ]In case of detection of measles vaccine virus strain excretion in breast milk, RT-PCR quantification measure of measles vaccine virus strain in woman breastmilk will be performed.
- Quantification of the measles vaccine virus strain presented in breast milk in at least one sample [ Time Frame: At day 14 after the first vaccination. ]In case of detection of measles vaccine virus strain excretion in breast milk, RT-PCR quantification measure of measles vaccine virus strain in woman breastmilk will be performed.
- Microscopy assessment of the infectious activity of the measles vaccine virus presented in breast milk in at least one sample. [ Time Frame: At day 7 ]In case of detection of measles vaccine virus strain excretion in breast milk. The evaluation of the infectious activity of the measles vaccine virus will be performed using an in vitro infectivity assay. A result will be considered as positive when at least one positive fluorescent cell is detected.
- Microscopy assessment of the infectious activity of the measles vaccine virus presented in breast milk in at least one sample. [ Time Frame: At day 11 after the first vaccination. ]In case of detection of measles vaccine virus strain excretion in breast milk. The evaluation of the infectious activity of the measles vaccine virus will be performed using an in vitro infectivity assay. A result will be considered as positive when at least one positive fluorescent cell is detected.
- Microscopy assessment of the infectious activity of the measles vaccine virus presented in breast milk in at least one sample. [ Time Frame: At day 14 after the first vaccination. ]In case of detection of measles vaccine virus strain excretion in breast milk. The evaluation of the infectious activity of the measles vaccine virus will be performed using an in vitro infectivity assay. A result will be considered as positive when at least one positive fluorescent cell is detected.
- Number of infant with positive salivary IgM/IgG [ Time Frame: one year after the first vaccination ]
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| Ages Eligible for Study: | 18 Years to 36 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women:
- Pregnant woman
- Age ≥ 18 years
- Planning to breastfeed her infant (mixed feeding is allowed)
- Having a negative serology for rubella during pregnancy
- Negative serology for measles based on the result from local laboratory
- Affiliated to a social security regimen
Infants:
- Informed consent form signed by the person(s) holding parental authority.
- Term newborn (≥36LMP)
Exclusion Criteria:
Women:
- Woman having a multiple pregnancy
- Woman planning to get pregnant in the month following the 2nd vaccination
- Woman with known or suspected HIV infection
- Woman with known or suspected immunodeficiency
- Woman with family history of hereditary immune deficiency
- Woman not mastering enough the reading / understanding of the French language to be able to consent to participate to the study
- Woman incapable to follow the procedures of the study and to respect study visits for the whole period of the study.
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Woman with contraindication for MMR vaccination:
- Scarce hereditary problems of fructose intolerance
- Woman with history of hypersensitivity to the active substances or to any of the excipients of the vaccine
- Administration of human gammaglobulins in the past 3 to 11 months depending on the dose of human globulins administered (except for Rhophylac®)
- Acute severe febrile illness within 7 days prior to injection
- Woman under systemic corticosteroids (prednisone, or equivalent ≥10 mg/day) within the previous 15 days or planning to use corticosteroids (i.e. prednisone, or equivalent ≥10 mg/day) during the 15 days following vaccination
- Woman under immunosuppressive therapy within the previous 3 months before vaccination or planning to use immunosuppressive therapy during the 15 days following vaccination Woman participating in any clinical trial with another investigational product 28 days prior to visit V0 or intent to participate in another clinical study with another investigational product at any time during the conduct of this study
- Any other reason which, according to the investigator, may interfere with the evaluation of the study objectives
- Woman with documented history of measles vaccination (1 or 2 doses) and/or history of documented measles
Infants:
- Blood draw is contraindicated or cannot be performed
- Infant with family history of hereditary immune deficiency
- Infant with suspected or confirmed immunodeficiency
- Any other reason which, according to the investigator, may interfere with the evaluation of the study objectives
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): NCT02325310
| France | |
| Cochin Port Royal Hospital - Centre d'Investigation Clinique Cochin-Pasteur | |
| Paris, France, 75014 | |
| Study Director: | Odile Launay, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT02325310 |
| Other Study ID Numbers: |
2014-001538-28 |
| First Posted: | December 24, 2014 Key Record Dates |
| Last Update Posted: | May 1, 2018 |
| Last Verified: | April 2018 |
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Vaccine strain excretion in breast milk Postpartum vaccination Breastfeeding women |
Measles-mumps-rubella vaccine Breast milk Vaccinology |
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Measles Rubella Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections |
RNA Virus Infections Virus Diseases Infections Rubivirus Infections Togaviridae Infections |