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

Respiratory Syncytial Virus Clinical Trial

— MORISOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325657
• Other study ID #: C3671032
• Status: Recruiting
• Phase: Phase 3
• Start date: March 12, 2024
• Est. completion date: June 11, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: June 11, 2025
• Est. primary completion date: June 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus

Intervention

Biological:
• RSVpreF vaccine
RSVpreF vaccine
• Placebp
Placebo

Locations

Country	Name	City	State
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Josha Research	Bloemfontein	FREE State
South Africa	REIMED Reiger Park	Boksburg	Gauteng
South Africa	Gugulethu Green Clinic	Cape Town	Western CAPE
South Africa	MRC Unit on Child And Adolescent Health	Cape Town	Western CAPE
South Africa	Synergy Biomed Research Institute	East London	Eastern CAPE
South Africa	University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)	Johannesburg	Gauteng
South Africa	Wits RHI	Johannesburg	Gauteng
South Africa	Wits VIDA Nkanyezi	Johannesburg	Gauteng
South Africa	Wits VIDA Nkanyezi Research Unit	Johannesburg	Gauteng
South Africa	Qhakaza Mbokodo Research Clinic	Ladysmith	Kwazulu-natal
South Africa	Gole Biomed Research Centre	Polokwane	Limpopo
South Africa	Botho Ke Bontle Health Services	Pretoria	Gauteng
South Africa	Setshaba Research Centre	Tshwane	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes	Describe specific birth outcomes for infant participants	Birth
Primary	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
Primary	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	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
Secondary	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

External Links

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