Respiratory Syncytial Virus Clinical Trial
Official title:
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
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04528719 -
A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
|
Phase 1 | |
Terminated |
NCT02508194 -
A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
|
Phase 2 | |
Active, not recruiting |
NCT06060457 -
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
|
Phase 3 | |
Terminated |
NCT01757496 -
Cough Assist in Bronchiolitis
|
N/A | |
Completed |
NCT00100373 -
RSV Challenge in Healthy Adults
|
N/A | |
Completed |
NCT03524118 -
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05572658 -
Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
|
||
Recruiting |
NCT06067230 -
A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults
|
Phase 3 | |
Completed |
NCT00246480 -
RSV Disease in the Elderly
|
||
Active, not recruiting |
NCT06097299 -
A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
|
Phase 2 | |
Completed |
NCT00889070 -
Respiratory Events Among Premature Infants
|
N/A | |
Unknown status |
NCT00613184 -
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
|
N/A | |
Completed |
NCT05559905 -
Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)
|
Phase 2 | |
Active, not recruiting |
NCT05127434 -
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
|
Phase 2/Phase 3 | |
Terminated |
NCT04978337 -
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
|
Phase 2 | |
Recruiting |
NCT06143046 -
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
|
Phase 2 | |
Active, not recruiting |
NCT05397223 -
A Study of Modified mRNA Vaccines in Healthy Adults
|
Phase 1 | |
Completed |
NCT02472548 -
A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine
|
Phase 1 | |
Completed |
NCT01562938 -
MEDI-557 Adult Dosing
|
Phase 1 | |
Completed |
NCT01734668 -
Sofia RSV FIA Field Study
|
N/A |