Respiratory Syncytial Virus infection Respiratory
Conditions
Interventions
To prepare sites to undertake a phase IV trial on RSVA B preF vaccine in pregnant women
Sponsors
Wits Vaccines and Infectious Diseases Analytics VIDA Research Unit
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women considered to be legally competent to consent for trial participation for herself and her newborn 2. Gestational age = 24 to <34 weeks who are not in active labour, using the GAIA criteria for gestational age assessment in pregnant women 3. Able to understand and comply with planned study procedures 4. Mother is attending ante-natal clinic 5. Mother has documented test for HIV and syphilis during the current pregnancy, done as part of standard of care 6. Provides written informed consent prior to initiation of study. If the maternal participant is illiterate, a witnessed thumb-printed informed consent is acceptable 7. Intention to deliver at a hospital or birthing facility where study procedures can be obtained 8. Expected to be available for the duration of the study and can be contacted by telephone during study participation 9. Participant is willing to give informed consent for her infant to participate in the study
Exclusion criteria
Exclusion criteria: 1)BMI >40 kg/m2 at first obstetric visit 2)Bleeding diathesis/ condition associated with prolonged bleeding that contra-indicates IM injection 3)Previous severe adverse reaction to a vaccine. 4)Current pregnancy complications/ abnormalities that will increase the risk associated with the participation and completion of stud 5)At least TWO prior pregnancy complications/abnormalities that will increase the risk associated with participation and completion of study 6)Mother test positive for syphilis during pregnancy 7)Mother with HIV/AIDS not on ART for at least three months or has Stage B/C AIDS or considered clinically unstable 8)Major illness of maternal participant or conditions of the fetus that will substantially increase risk associated with the maternal participant’s participation and completion of study 9)Congenital/ acquired immunodeficiency or rheumatologic disorders or other illness requiring chronic treatment with immunosuppressant medications within the year prior to enrolment 10)Other acute/chronic medical/psychiatric condition including recent/ active suicidal ideation/behaviour/laboratory abnormality that may increase the risk associated with study participation 11)Participation in other studies with investigational drug/s within 28 days prior to consent and/or during study participation. 12)Use of systemic corticosteroids for >14 days within 28 days prior to enrolment 13)Prednisone use of <20 mg/day for =14 days is permitted. Inhaled/nebulized,intra-articular, intra-bursal, or topical corticosteroids are permitted 14)Current alcohol abuse or illicit drug use 15)Receipt of blood/ plasma products/ Ig in past 60 days/ planned receipt through delivery except Rho(D) immune globulin 16)Previous vaccination with any licensed/investigational RSV vaccine or planned receipt during study NB: Shortened d/t space restriction. Refer to protocol for details
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To ascertain overall and site-specific rates of adverse pregnancy outcomes, focused on preterm birth (1000 grams).;To determine the overall and site-specific incidence of all-cause and RSV-confirmed LRTI from birth up to a 180 days of age | — |
Secondary
| Measure | Time frame |
|---|---|
| To ascertain overall and site-specific rates of low birth weight (<2500 grams), and association thereof with preterm birth and small for gestational age.;To determine the efficiency of transplacental transfer of RSV and tetanus IgG from the mother to newborn, including comparing between sites, in a subset of participants (100 per country, including 50-100 per site). | — |
Countries
Gambia, Ghana, Kenya, South Africa
Contacts
Public ContactShabir;Ziyaad Madhi;Dangor
Executive Director and National Principal Investigator;Scientific Director
Outcome results
None listed