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

NCT06325657 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: C3671032
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 14

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.

Conditions

Respiratory Syncytial Virus

Keywords

Respiratory Tract Infection; HIV; Maternal; Vaccine

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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

Study Arms (2)

RSVpreF vaccine

EXPERIMENTAL

RSV vaccine (RSVpreF)

Biological: RSVpreF vaccine

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebp

Interventions

RSVpreF vaccine BIOLOGICAL

RSVpreF vaccine

RSVpreF vaccine

Placebp BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 0 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (14)

Synergy Biomed Research Institute

East London, Eastern Cape, 5241, South Africa

Location

Josha Research

Bloemfontein, Free State, 9301, South Africa

Location

Worthwhile Clinical Trials

Benoni, Gauteng, 1500, South Africa

Location

REIMED Reiger Park

Boksburg, Gauteng, 1459, South Africa

Location

Wits RHI

Johannesburg, Gauteng, 2001, South Africa

Location

University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

Johannesburg, Gauteng, 2013, South Africa

Location

Wits VIDA Nkanyezi Research Unit

Johannesburg, Gauteng, 2093, South Africa

Location

Setshaba Research Centre

Pretoria, Gauteng, 0152, South Africa

Location

Botho Ke Bontle Health Services

Pretoria, Gauteng, 0184, South Africa

Location

Qhakaza Mbokodo Research Clinic

Ladysmith, KwaZulu-Natal, 3370, South Africa

Location

Gole Biomed Research Centre

Polokwane, Limpopo, 0699, South Africa

Location

MRC Unit on Child And Adolescent Health

Cape Town, Western Cape, 7700, South Africa

Location

Gugulethu Green Clinic

Cape Town, Western Cape, 7750, South Africa

Location

FAMCRU - Worcester

Worcester, Western Cape, 6850, South Africa

Location

Related Publications (1)

• Myer L, Wasserman E, Tabasum S, Shittu E, Liu Y, Jose L, Horne E, Moraba RS, Wilhase A, Zar HJ, Hussen N, Mogashoa MS, Malahleha M, Madhi SA, Sarwar UN, Snaggs H, Erdem R, Radley D, Kalinina EV, Pahud BA, Maddalena Lino M, Anastasiou OE, Swanson KA, Anderson AS, Gurtman A, Munjal I. Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV. Vaccines (Basel). 2025 Dec 1;13(12):1218. doi: 10.3390/vaccines13121218.

  PMID: 41441684 DERIVED

Related Links

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

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded, placebo-controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 22, 2024
• Study Start: March 12, 2024
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ZA (14)