RSV Vaccination + Immunization for Respiratory Syncytial Virus

Not currently recruiting at 7 trial locations

Overseen By Christina Rostad

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Psychiatric disease, Immune impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well two new treatments, Abrysvo and Beyfortus, prevent severe RSV infections in infants. It focuses on a vaccine for pregnant mothers and an antibody treatment for newborns. Researchers assess the duration and strength of the protection these treatments provide to babies. Expectant mothers with uncomplicated pregnancies planning to deliver in a hospital are suitable candidates for this study. As a Phase 4 trial, these treatments have already received FDA approval and proven effective, and this research aims to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken immunosuppressive drugs or certain biologic agents within 30 days before enrolling. Inhaled, topical, or certain other forms of steroids are allowed.

What is the safety track record for these treatments?

Research has shown that both Abrysvo and Beyfortus are safe for preventing RSV in babies. In studies, Abrysvo, a vaccine administered to pregnant women, generally demonstrated a good safety record. Most side effects were mild, such as pain at the injection site and headaches, while serious reactions were rare.

Beyfortus, a treatment given directly to infants, also demonstrated a good safety record. Trials indicated that most babies tolerated it well, with only mild side effects like a rash or slight fever. Serious side effects were uncommon.

Both treatments have received FDA approval for preventing RSV in babies, indicating thorough safety testing. Overall, both Abrysvo and Beyfortus appear well-tolerated with manageable side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for RSV (Respiratory Syncytial Virus) because they offer new preventive strategies. Abrysvo is unique because it involves a maternal vaccination with RSVpreF, given to pregnant women, which may help protect newborns by transferring antibodies before birth. Beyfortus, on the other hand, provides passive immunity directly to infants through a monoclonal antibody, nirsevimab, which is geared towards protecting babies either at birth or around three months of age. These treatments are different from the standard of care, which typically includes supportive care and, in some cases, palivizumab for high-risk infants, as they aim to prevent RSV infections in a broader infant population, potentially reducing the burden of the disease from an early stage.

What evidence suggests that this trial's treatments could be effective for preventing RSV in infants?

Studies have shown that the RSV vaccine, Abrysvo, effectively prevents RSV infections in babies. Research indicates that Abrysvo can lower the risk of RSV-related lung infections requiring medical attention by 81%. In this trial, some participants will receive Abrysvo. Additionally, the monoclonal antibody nirsevimab, known as Beyfortus, demonstrated impressive results, with 87.2% effectiveness against RSV-related lung infections. It also reduces hospitalizations due to severe RSV cases by 98%. Other participants in this trial will receive Beyfortus. Both treatments provide strong protection against RSV, helping to keep babies safe from serious breathing problems. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy infants at risk of Respiratory Syncytial Virus (RSV) infection. It includes those whose mothers are vaccinated during pregnancy with ABRYSVO and infants receiving BEYFORTUS at birth or the start of RSV season. Specific eligibility criteria were not provided.

Inclusion Criteria

I am between 18-45 years old, pregnant with one baby, and not at high risk for pregnancy complications.

Understands and agrees to comply with all study procedures

I plan to give birth in a hospital or facility that can perform study procedures.

Exclusion Criteria

Maternal conditions known to impair transplacental transfer of maternal antibodies (e.g., placental pathology, hypergammaglobulinemia, HIV)

Maternal history of preterm birth (<34 weeks GA)

I have a condition or treatment that weakens my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers receive RSVpreF vaccine during pregnancy and infants receive nirsevimab at birth or at 3 months

12 months

Multiple visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at Day 1, 43, 91, 181, and 366

What Are the Treatments Tested in This Trial?

Interventions

• Abrysvo
• Beyfortus

Trial Overview The study tests the immune response in infants to either maternal vaccination with ABRYSVO, infant immunization with BEYFORTUS, or both. It's a Phase 4 trial aiming to understand how well these interventions protect against RSV over the first year of life.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

Mother does NOT receive maternal RSVpreF and infant receives one dose of nirsevimab (BEYFORTUS) 50mg/0.5mL if body weight \<5kg or 100mg/mL if body weight is \>= 5kg at birth . N= 50.

Group II: Group 1C Experimental Treatment 2 Interventions

Mother receives 120 mcg/0.5ml of maternal RSVpreF (ABRYSVO) administered intramuscularly once during 32 0/7 to 36 6/7 weeks GA and infant receives one dose of nirsevimab (BEYFORTUS) 50mg/0.5mL if body weight \<5kg or 100mg/mL if body weight is \>= 5kg at 3-month . N= 50.

Group III: Group 1B Experimental Treatment 2 Interventions

Mother receives 120 mcg/0.5ml of maternal RSVpreF (ABRYSVO) administered intramuscularly once during 32 0/7 to 36 6/7 weeks GA and infant receives one dose of nirsevimab (BEYFORTUS) 50mg/0.5mL if body weight \<5kg or 100mg/mL if body weight is \>= 5kg at birth. N= 50.

Group IV: Group 1A Experimental Treatment 1 Intervention

Mother receives 120 mcg/0.5ml of maternal RSVpreF (ABRYSVO) administered intramuscularly once during 32 0/7 to 36 6/7 weeks GA and infant does NOT receive nirsevimab. N= 50.

Abrysvo is already approved in United States for the following indications:

Approved in United States as ABRYSVO for:

• Prevention of RSV lower respiratory tract disease in infants

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

The BVAC-B immunotherapy, tested in eight patients with HER2-positive advanced gastric cancer, showed a safe toxicity profile with no dose-limiting toxicities, although treatment-related adverse events like fever were noted at medium and high doses.

While BVAC-B demonstrated limited clinical activity, it successfully activated immune responses in patients, suggesting that earlier intervention or combination therapies may enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Phase 1 Study of a B Cell- and Monocyte-Based Immunotherapeutic Vaccine Against HER2-Positive Advanced Gastric Cancer. Jung, M., Lee, JB., Kim, HS., et al.[2023]

The novel PD-1 B-cell peptide vaccine (PD1-Vaxx) demonstrated superior efficacy compared to standard anti-PD-1 monoclonal antibodies in preclinical mouse models of colon carcinoma, suggesting it may be a promising alternative for cancer treatment.

Combining PD1-Vaxx with a HER-2 peptide vaccine resulted in enhanced tumor growth inhibition, and both vaccines showed a favorable safety profile with no observed toxicity or autoimmunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and antitumor efficacy of a novel human PD-1 B-cell vaccine (PD1-Vaxx) and combination immunotherapy with dual trastuzumab/pertuzumab-like HER-2 B-cell epitope vaccines (B-Vaxx) in a syngeneic mouse model. Kaumaya, PTP., Guo, L., Overholser, J., et al.[2021]

Nivolumab, an immune checkpoint inhibitor, shows a low rate of severe adverse effects (grade ≥3 AEs at 12%) and a very low mortality rate (0.25%), indicating it is a relatively safe treatment option for cancer patients.

In terms of efficacy, nivolumab demonstrates better treatment responses and survival rates compared to traditional chemotherapy, with a 1-year overall survival rate of 52% and a significantly higher objective response rate (ORR) of 26%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nivolumab in the treatment of cancers: A meta-analysis of 27 prospective clinical trials. Tie, Y., Ma, X., Zhu, C., et al.[2022]

In a study of 75 non-small cell lung cancer patients treated with nivolumab, 43% experienced immune-related adverse events (irAEs), primarily affecting the skin, lungs, and gastrointestinal system, with most being of moderate severity.

Patients who developed irAEs had significantly better treatment outcomes, with a median progression-free survival of 9.49 months compared to 1.99 months for those without irAEs, indicating that these adverse events may serve as strong predictors of treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of immune-mediated reactions in patients with non-small cell lung cancer treated with nivolumab and its association with effectiveness. Cortijo-Cascajares, S., Cercós-Lletí, AC., Ortiz-Pérez, S., et al.[2023]

Tocilizumab demonstrated a clinical benefit in 85% of cancer patients treated for immune-related adverse events (irAEs) associated with immune checkpoint inhibitors, with no cases of disease progression reported during treatment.

The study suggests that tocilizumab can be safely continued alongside immune checkpoint inhibitors in managing irAEs, allowing for effective treatment without compromising cancer therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tocilizumab for the treatment of immune-related adverse events: a systematic literature review and a multicentre case series. Campochiaro, C., Farina, N., Tomelleri, A., et al.[2021]

Rituximab-treated patients with B cell non-Hodgkin lymphoma (NHL) showed significant humoral immunodeficiency, with only 20% responding to diphtheria and pneumococcal vaccinations, despite having relatively normal IgG levels.

Subcutaneous immunoglobulin (subq Ig) therapy was well-tolerated and significantly increased serum IgG levels, leading to a reduction in nonneutropenic infections, indicating its efficacy as a supportive treatment for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of 20% Subcutaneous Immunoglobulin Replacement Therapy in Patients With B Cell Non-Hodgkin Lymphoma With Humoral Immune Dysfunction After Treatment With Rituximab. Mustafa, SS., Jamshed, S., Vadamalai, K., et al.[2021]

In a postmarketing surveillance study of 3601 Japanese patients with advanced non-small-cell lung cancer treated with nivolumab, the treatment-related adverse events occurred in 47.1% of patients, with 15.9% experiencing grade 3 or higher events, indicating a manageable safety profile similar to clinical trials.

The most common adverse events included interstitial lung disease (6.4%), hypothyroidism (5.7%), and diarrhea (4.4%), with specific risk factors identified for these events, suggesting that careful monitoring is needed for patients with certain pre-existing conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world safety of nivolumab in patients with non-small-cell lung cancer in Japan: Postmarketing surveillance. Yamamoto, N., Nakanishi, Y., Gemma, A., et al.[2021]

Nirsevimab is a newly approved long-acting monoclonal antibody for preventing respiratory syncytial virus (RSV) infection in newborns and infants, allowing for a single dose to protect throughout the RSV season, which is a significant improvement over the monthly injections required for the existing treatment, palivizumab.

The drug works by targeting a specific site on the RSV fusion protein and has shown positive results in Phase 2b and 3 clinical trials, indicating its efficacy and potential to reduce hospitalizations and mortality associated with RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nirsevimab: review of pharmacology, antiviral activity and emerging clinical experience for respiratory syncytial virus infection in infants. Jorgensen, SCJ.[2023]

The abstract lists a wide range of medical interventions and drugs, indicating a comprehensive review of various treatments, but does not provide specific efficacy or safety data for any individual treatment.

The mention of numerous drugs and therapies suggests a focus on exploring diverse therapeutic options, but without detailed results or conclusions, the effectiveness or mechanisms of action remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. Tomillero, A., Moral, MA.[2008]

Citations

1. cdc.gov cdc.gov/acip/grade/Pfizer-Bivalent-RSVpreF-adults.html

Pfizer RSVpreF Vaccine (ABRYSVO) | ACIP Pfizer RSVpreF also reduced the risk of medically attended RSV LRTI (vaccine efficacy: 81.0% (95% CI: 43.5%, 95.2%) (Table 3b). The trial was ...

2. abrysvoadult.pfizerpro.com abrysvoadult.pfizerpro.com/about-abrysvo/efficacy-profile

Safety Info Season 1 and season 2 vaccine efficacy estimates reflect efficacy data from 2 RSV seasons, from August 2021 through November 2023. Vaccine efficacy across 2 ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828028

Estimated Vaccine Effectiveness for Respiratory Syncytial ... In our primary analysis, RSVpreF effectiveness was 89% against RSV-related LRTD requiring hospitalization or ED visit among adults aged 60 years ...

4. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-full-season-two

Pfizer Announces Positive Top-Line Data for Full Season ... ABRYSVO efficacy was 77.8% against RSV lower respiratory tract disease with three or more symptoms in a second full RSV season in adults 60 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11645642/

Estimated Vaccine Effectiveness for Respiratory Syncytial ... Using broad controls, estimated adjusted VE was 87% (95% CI, 48%-97%). Conclusions and Relevance. In a high-risk, general population, RSVpreF ...

6. fda.gov fda.gov/media/168889/download

Package Insert - ABRYSVO (STN 125769) ABRYSVO (Respiratory Syncytial Virus Vaccine) is a sterile solution for intramuscular injection. The vaccine is supplied as a vial of Lyophilized Antigen ...

7. abrysvomaternal.pfizerpro.com abrysvomaternal.pfizerpro.com/about-abrysvo/safety

Safety Profile for ABRYSVO® (Respiratory Syncytial Virus ... See the safety profile for ABRYSVO, an RSV vaccine to help prevent RSV in infants from birth through 6 months, given to pregnant women at 32 to 36 weeks ...

8. cdc.gov cdc.gov/vaccine-safety/vaccines/rsv.html

Respiratory Syncytial Virus (RSV) Vaccine Safety Clinical trial safety data. In clinical trials assessing the safety of Pfizer RSV vaccine (Abrysvo) in pregnant women at 24 through 36 weeks ...

9. abrysvo.com abrysvo.com/

ABRYSVO® (Respiratory Syncytial Virus Vaccine) by Pfizer ... Pfizer's ABRYSVO is a vaccine to prevent respiratory disease from RSV. It is recommended for adults aged 75+ years and 50 to 74 with certain chronic conditions.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973799/

Safety surveillance of respiratory syncytial virus (RSV) ... Over half of the RSVpreF-linked reports, 54.6%, were deemed serious; among these, 47.5% led to hospitalisations, 25.4% to doctor or clinic ...