A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PREGNANT PARTICIPANTS LIVING WITH HIV AND THEIR INFANTS
Overview
- Phase
- Phase 3
- Intervention
- RSVpreF vaccine
- Conditions
- Respiratory Syncytial Virus
- Sponsor
- Pfizer
- Enrollment
- 648
- Locations
- 14
- Primary Endpoint
- Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.
The study will look at the safety, tolerability, and immune activity in mothers and their infants.
This study is seeking pregnant women who are:
- Less than or equal to 49 years old and have HIV (Human immunodeficiency virus -
- Receiving standard medical care during the pregnancy
- Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection).
- Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days.
- agree to be present for all study visits, procedures, and blood draws.
Participants will either receive:
- RSVpreF vaccine
- A placebo. A placebo does not have any medicine it but looks just like the study vaccine.
Pregnant participants will be involved in the study from:
- consent during their current pregnancy, and
- for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
RSVpreF vaccine
RSV vaccine (RSVpreF)
Intervention: RSVpreF vaccine
Placebo
Placebo
Intervention: Placebp
Outcomes
Primary Outcomes
Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes
Time Frame: Birth
Describe specific birth outcomes for infant participants
Maternal Participants Primary Safety - The proportion of participants reporting Adverse Event of Special Interests (AESIs)
Time Frame: Throughout the study duration (approximately 10 months)
AESIs include preterm delivery, diagnosis of GB syndrome, Diagnosis of Acute polyneuropathy without underlying etiology, hypertensive disorders of pregnancy, atrial fibrillation.
Infant Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs)
Time Frame: Through 1 month following birth
An AE is any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs include both serious and non-serious adverse events.
Maternal Participants Primary Safety - The proportion of participants reporting systemic reactions
Time Frame: Within 7 days following study administration intervention
Systemic Reactions: fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded based on e-diary and participant reported reactogenicity events.
Maternal Participants Primary Safety - The proportion of participants reporting local reactions
Time Frame: Within 7 days following study administration intervention
Local reactions included pain at injection site, redness and swelling recorded based on e-diary and participant reported reactogenicity events.
Maternal Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs)
Time Frame: Through 1 month following study administration intervention
An adverse event was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Adverse events included both serious and non-serious adverse events.
Maternal Participants Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs)
Time Frame: Throughout the study duration (approximately 10 months)
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Infant Participants Primary Safety - The proportion of participants reporting SAEs and Newly Diagnosed Chronic Medical Conditions (NDCMCs)
Time Frame: Throughout the study duration (approximately 6 months)
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects.
Secondary Outcomes
- Maternal Participants: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B(Before vaccination and at the delivery visit)
- Maternal Participants: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B(From before vaccination and to the delivery visit)