Respiratory Respiratory Syncytial Virus Infection
Conditions
Interventions
Placebo
Sponsors
Wits Health Consortium
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women considered to be legally competent, as per country legislation, to consent for trial participation for herself and her newborn. 2. At a gestational age in keeping with in-country approval of the vaccine administration, and not in active labour. Gestational age will be based on GAIA LOC 1 to 2B criteria 3. Mother is able to understand and comply with planned trial procedures. 4. Mother is attending ante-natal clinic. 5. Mother has documented test for HIV and syphilis during the current pregnancy 6. Provides written informed consent prior to initiation of trial. 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 trial procedures can be obtained (for immunogenicity cohort). 8. Expected to be available for the duration of the trial and can be contacted by telephone or by physical visit during trial participation. 9. Participant is willing to give informed consent for her infant to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. BMI of >40 kg/m2 at the time of first obstetric visit during current pregnancy 2. Bleeding diathesis or condition (past or present) that would contraindicate intramuscular injection 3. History of severe adverse reaction associated with a vaccine 4. Current pregnancy complications/ abnormalities at time of consent that will increase risk associated with the participation in and completion of the trial 5. At least THREE prior pregnancy complications or abnormalities at time of consent that will increase risk associated with the participation in and completion of the trial 6. Mother who is positive for syphilis and untreated at enrolment. 7. Mother living with HIV/AIDS considered to have WHO Clinical Stage 3/4 AIDS or clinically unstable 8. Major illness of maternal participant or conditions of the foetus that, will substantially increase the risk associated with participation and completion of trial. 9. Congenital/acquired immunodeficiency or rheumatologic disorders or rheumatologic disorder or other illness requiring chronic treatment with immunosuppressant medications 10. Other acute/chronic medical/psychiatric condition including recent/active suicidal ideation/behaviour/laboratory abnormality that may increase the risk associated with trial participation 11. Participation in other studies involving investigational drug(s) within 28 days prior to consent and during trial participation. 12. Use of systemic corticosteroids for >14 days within 28 days prior to trial enrolment. Prednisone use of <20 mg/day for =14 days is permitted. Inhaled/nebulized, intra-articular, intra-bursal, or topical corticosteroids are permitted. 13. Current alcohol abuse or illicit drug use. 14. Receipt of blood/plasma products/ Ig in past 60 days/ planned receipt through delivery except Rho(D) immune globulin 15. Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during trial participation NB shortened d/t space restriction. Refer to protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of RSVA/B-preF against RSV-A or RSV-B subtype confirmed severe LRTI through to 180 days of age. The severity of LRTI will be based on the WHO grading criteria;Evaluate the safety of RSVA/B-preF in relation to preterm births (born at <37 weeks GA) in women with gestational age (GA) staging Level of Certainty [LOC] 1 to 2B at time of enrolment. The GA staging will be based on Global Alignment on Immunization safety Assessment (GAIA) criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of RSVA/B-preF against RSV-confirmed severe LRTI through to 90, 120 and 150 days of age;Evaluate the efficacy of RSVA/B-preF against RSV-confirmed LRTI resulting in (i) hospitalization and (ii) with use of supplemental oxygen OR O2 saturation of <92% (at 180 days, and 90, 120 & 150 days).;Evaluate the efficacy of RSVA/B-preF against RSV-confirmed MA-LRTI and very-severe LRTI (at 180 days, and 90, 120 and 150 days);Evaluate the efficacy of RSVA/B-preF against RSV-confirmed: a. MA-LRTI; b. severe-LRTI; c. very-severe LRTI; d. LRTI hospitalization from 0 to 90 days and 91-180 days;Evaluate the efficacy of RSVA/B-preF against all-cause: a. MA-LRTI; b. severe LRTI; c. very-severe LRTI; d. LRTI hospitalization, at 180 days, and 90, 120, and 150 days; and at 0-90 days and 91-180 days of age;Evaluate the safety of RSVA/B-preF against prematurity in women vaccinated at 28 to <32 weeks, 32 to 36 weeks, limited to women with GA staging using GAIA LOC 1 to 2B at time of enrolment;Evaluate the safety of RSVA/B-preF against prematurity occurring at 28 to <32 weeks, 32 to 36 weeks, limited to women with GA staging using GAIA LOC 1 to 2B at time of enrolment;Evaluate the safety of RSVA/B-preF against low birth weight (<2500 grams) and very low birth weight (<1500 grams) | — |
Countries
Kenya, South Africa
Contacts
Public ContactLisa Nunes
Clinical Trial Site Manager Regulatory
Outcome results
None listed