A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants (MORISOT)

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immunogenicity of Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Pregnant Participants Living With HIV and Their Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Syncytial Virus
• Intervention / Treatment: Biological: RSVpreF vaccine; Biological: Placebp

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• South Africa
  • Eastern CAPE
    • East London, Eastern CAPE, South Africa, 5241
      • Not yet recruiting
      • Synergy Biomed Research Institute
  • FREE State
    • Bloemfontein, FREE State, South Africa, 9301
      • Not yet recruiting
      • Josha Research
  • Gauteng
    • Benoni, Gauteng, South Africa, 1500
      • Recruiting
      • Worthwhile Clinical Trials
    • Boksburg, Gauteng, South Africa, 1459
      • Not yet recruiting
      • REIMED Reiger Park
    • Johannesburg, Gauteng, South Africa, 2001
      • Not yet recruiting
      • Wits RHI
    • Johannesburg, Gauteng, South Africa, 2013
      • Not yet recruiting
      • University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
    • Johannesburg, Gauteng, South Africa, 2093
      • Not yet recruiting
      • Wits VIDA Nkanyezi
    • Johannesburg, Gauteng, South Africa, 2093
      • Not yet recruiting
      • Wits VIDA Nkanyezi Research Unit
    • Pretoria, Gauteng, South Africa, 0184
      • Recruiting
      • Botho Ke Bontle Health Services
    • Tshwane, Gauteng, South Africa, 0152
      • Not yet recruiting
      • Setshaba Research Centre
  • Kwazulu-natal
    • Ladysmith, Kwazulu-natal, South Africa, 3370
      • Not yet recruiting
      • Qhakaza Mbokodo Research Clinic
  • Limpopo
    • Polokwane, Limpopo, South Africa, 0734
      • Recruiting
      • Gole Biomed Research Centre
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7700
      • Not yet recruiting
      • MRC Unit on Child And Adolescent Health
    • Cape Town, Western CAPE, South Africa, 7750
      • Not yet recruiting
      • Gugulethu Green Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria - Maternal Participants

• Women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated singleton pregnancy who are at no known increased risk for complications.
• Confirmed stable HIV disease.
• Current and stable use of antiretroviral therapy(ART) for at least 90 days prior to enrolment.
• Had a fetal anomaly ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed.
• Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
• Participant is willing to give informed consent for the participant's infant to participate in the study.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Key Inclusion Criteria - Infant Participants

• Evidence of a signed and dated ICD, signed by the parent(s)/legal guardian(s).
• Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures

Key Exclusion Criteria - Maternal Participants

• Prepregnancy body mass index (BMI) of >40 kg/m2 . If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
• Participant with opportunistic infections or malignancy.
• History of active chronic viral hepatitis with biochemical evidence of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal within 6 months before enrollment.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
• Current pregnancy resulting from in vitro fertilization. Participants known to have used clomiphene citrate and/or letrozole with or without intrauterine insemination (IUI) are permitted.
• Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not l limited to the following:
• Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
• Placental abnormality.
• Polyhydramnios or oligohydramnios.
• Significant bleeding or blood clotting disorder.
• Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent.
• Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth.
• 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 study, including but not limited to the following:
• Prior preterm delivery at ≤34 weeks' gestation
• Prior stillbirth or neonatal death
• Previous infant with a known genetic disorder or significant congenital anomaly
• Non-HIV-associated congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications.
• Antituberculosis treatment use currently or at any time during this current pregnancy.

Key Exclusion Criteria - Infant Participants

• Infant who is a direct descendant (eg, child or grandchild) of the investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebp; Placebo
Experimental: RSVpreF vaccine; RSV vaccine (RSVpreF)	Biological: RSVpreF vaccine; RSVpreF vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Participants Primary Safety - The proportion of participants reporting systemic reactions	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.	Within 7 days following study administration intervention
Maternal Participants Primary Safety - The proportion of participants reporting local reactions	Local reactions included pain at injection site, redness and swelling recorded based on e-diary and participant reported reactogenicity events.	Within 7 days following study administration intervention
Maternal Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs)	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.	Through 1 month following study administration intervention
Maternal Participants Primary Safety - The proportion of participants reporting Adverse Event of Special Interests (AESIs)	AESIs include preterm delivery, diagnosis of GB syndrome, Diagnosis of Acute polyneuropathy without underlying etiology, hypertensive disorders of pregnancy, atrial fibrillation.	Throughout the study duration (approximately 10 months)
Maternal Participants Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs)	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.	Throughout the study duration (approximately 10 months)
Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes	Describe specific birth outcomes for infant participants	Birth
Infant Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs)	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.	Through 1 month following birth
Infant Participants Primary Safety - The proportion of participants reporting SAEs and Newly Diagnosed Chronic Medical Conditions (NDCMCs)	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.	Throughout the study duration (approximately 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Participants: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B	GMT of NTs for RSV A and RSV B before vaccination and at the delivery visit	Before vaccination and at the delivery visit
Maternal Participants: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B	GMFR of NTs for RSV A and RSV B from before vaccination to post vaccination blood-sampling visit	From before vaccination and to the delivery visit

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): June 11, 2025
• Study Completion (Estimated): June 11, 2025

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HIV; Vaccine; Maternal; Respiratory Tract Infection
• Other Study ID Numbers: C3671032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No