HIV, RSV Immunization
Conditions
Keywords
HIV, RSVpreF, RSV
Brief summary
Respiratory syncytial virus (RSV) is the leading cause of hospitalization in young infants in Canada. While most babies recover, RSV can cause severe breathing problems and place major stress on families and the health system. Infants born to pregnant women and people with HIV, even if they do not acquire the virus, face higher risks of RSV illness. This is partly because HIV increases the chance of preterm birth and can reduce the amount of protective antibodies passed to the baby during pregnancy. Two new tools now exist to prevent RSV. One is a vaccine given in late pregnancy (RSVpreF), which boosts antibodies that cross the placenta and protect the baby at birth. The other is a long-lasting antibody (nirsevimab) given directly to infants after delivery. Both work well in the general population, but pregnant people living with HIV were excluded from the original studies. Health care providers therefore do not know if perinatal vaccination provides enough protection for these babies. This study will follow 20 pregnant women/people with HIV at BC Women's Hospital who receive the RSVpreF vaccine. Antibody levels will be measured before and after vaccination from the pregnant recipient, and in infant blood sample, to see how well protection is transferred to infants. We will also assess vaccine safety, birth outcomes, and parental views on RSV immunization. Findings will guide Canadian policies to ensure that all infants, including those exposed to HIV, have equitable access to RSV protection.
Interventions
DRUGRSVpreF
Participants will receive a single dose of the RSVpreF vaccine (Abrysvo®) intramuscularly between 32+0 and 36+6 weeks of gestation, consistent with Health Canada approval.
Sponsors
University of British Columbia
Women's Health Research Institute of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant women/people aged ≥19 years 2. Confirmed diagnosis of HIV 3. Gestational age between 28 and 34 weeks at enrollment (to allow scheduling of vaccination at 32-36 weeks) 4. Able to provide informed consent
Exclusion criteria
1. Contraindications to RSVpreF vaccine per product monograph 2. History of severe allergic reaction to any vaccine component 3. Planned delivery outside of British Columbia 4. Received RSVpreF in current or previous pregnancy 5. Received immunoglobulins (except Rh (D) immuneglobulin) within 1 year of enrollment 6. Unable to complete in-person follow-up for infant at the Oak Tree Clinic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | Within 10 weeks | To measure the RSV neutralizing antibody geometric mean titer and geometric mean ratio in twenty pregnant women/people with HIV at pre-vaccination (32-36 weeks) and post-vaccination (4 weeks post-vaccination) from RSVpreF |
| Transplacental Antibody | 8-10 weeks | To measure the RSV neutralizing antibody geometric mean titer and geometric mean ratio through infant dried blood spots after birth among twenty infants born to pregnant people with HIV immunized with RSVpreF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile and reactogenicity | 8-10 weeks | Among pregnant women/people with HIV vaccinated with RSVpreF, proportion of individuals with fatigue, headache, and fever will be determined |
| Pregnancy Factors | 8-10 weeks | Among pregnant women/people with HIV vaccinated with RSVpreF, gestational age at delivery and rate of adverse birth outcomes (e.g., rate of preterm birth, low birth weight) will be determined as percentage of cohort. |
| Acceptability | 4 weeks | To understand the acceptability of RSV immunization strategies among pregnant women/people with HIV, presented as descriptive statistics based on proportion who would accept repeat vaccination and/or recommend to others |
Contacts
CONTACTJeffrey MH Wong, MD, FRCSC
Outcome results
None listed