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Compares treatment options for RSV Infections
Official title A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.
ClinicalTrials.gov ID: NCT06955728
What this study is testing
What is Vaccine?
Vaccine is an investigational medicine, being studied as a potential treatment for rsv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant women considered to be legally competent, as per country legislation, to consent for trial participation for herself and her newborn
- 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...
- Mother is able to understand and comply with planned trial procedures
- Mother is attending ante-natal clinic
- Mother has documented test for HIV and syphilis during the current pregnancy,
You likely can't join if
- Body mass index of \>40 kg/m2 at the time of the first obstetric visit during the current pregnancy
- Bleeding diathesis or condition (past or present) associated with prolonged bleeding that would, in the opinion of the investigator, contra-indicate...
- History of severe adverse reaction associated with a vaccine
- Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and...
- More than two fetuses (i.e. twins will be allowed)
- Preeclampsia, eclampsia, or uncontrolled gestational hypertension
See the full eligibility criteria
- Pregnant women considered to be legally competent, as per country legislation, to consent for trial participation for herself and her newborn
- 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
- Mother is able to understand and comply with planned trial procedures
- Mother is attending ante-natal clinic
- Mother has documented test for HIV and syphilis during the current pregnancy,
- Provides written informed consent prior to initiation of trial. If the maternal participant is illiterate, a witnessed thumb-printed informed consent is acceptable
- Intention to deliver at a hospital or birthing facility where trial procedures can be obtained (for immunogenicity cohort)
- Expected to be available for the duration of the trial and can be contacted by telephone or by physical visit during trial participation
- Participant is willing to give informed consent for her infant to participate in the trial
- Body mass index of \>40 kg/m2 at the time of the first obstetric visit during the current pregnancy
- Bleeding diathesis or condition (past or present) associated with prolonged bleeding that would, in the opinion of the investigator, contra-indicate intramuscular injection
- History of severe adverse reaction associated with a vaccine
- Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the trial, including but not limited to the following:
- More than two fetuses (i.e. twins will be allowed)
- Preeclampsia, eclampsia, or uncontrolled gestational hypertension
- Known placental abnormality.
- Known polyhydramnios or oligohydramnios
- Known endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism, or uncontrolled diabetes mellitus at the time of consent.
- Any signs of premature labour with the current pregnancy or having ongoing intervention (medical/ surgical) in the current pregnancy to prevent preterm birth.
- At least THREE prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the trial...
- Prior preterm delivery between 18 to ≤34 weeks gestation, or birth weight \<2200 grams; (may be based on maternal history of prior preterm delivery where these details are not otherwise documented)
- Prior stillbirth or neonatal death within 7 days of birth.
- Previous infant with a known genetic disorder or major congenital anomaly
- Mother who is positive for syphilis and untreated at time of enrolment
- Mother living with HIV/AIDS considered to have WHO Clinical Stage 3 or 4 AIDS, or considered to be clinically unstable
- Major illness of the maternal participant or conditions of the foetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal participant's participation in, and...
- Known or history of congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies...
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour or laboratory abnormality that may increase the risk associated with trial...
- Participation in other studies involving investigational drug(s) within 28 days prior to consent and/or during trial participation.
- 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 (skin or eyes)...
- Current alcohol abuse or illicit drug use
- Receipt of blood or plasma products or immunoglobulin (Ig) in past 60 days or planned receipt through delivery, with exception of Rho(D) immune globulin (eg, RhoGAM), which can be given at any time
- Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during trial participation
The study team makes the final eligibility decision.
Where it's taking place
- Kintampo, Bono East, Ghana
- Dodowa, Greater Accra Region, Ghana
- Kilifi, Kilifi County, Kenya
- Kisumu, Nyanza, Kenya
- Hillbrow, Gauteng, South Africa
- Johannesburg, Gauteng, South Africa
- Soshanguve, Gauteng, South Africa
- Soweto, Gauteng, South Africa
- Durban, KwaZulu-Natal, South Africa
- Rondebosch, Western Cape, South Africa
- Basse Santa Su, Upper River Division, The Gambia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kintampo, Bono East, Ghana; Dodowa, Greater Accra Region, Ghana; Kilifi, Kilifi County, Kenya; Kisumu, Nyanza, Kenya; Hillbrow, Gauteng, South Africa; Johannesburg, Gauteng, South Africa and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.