Adjuvanted RSV Vaccine for Respiratory Syncytial Virus

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must be taking: Immunosuppressive therapy

Must not be taking: Anti-CD20 agents

Disqualifiers: Dementia, Cardiovascular, Hepatic, Neurological, others

Stay on Your Current Meds You can continue your current medications while participating

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: 4

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine designed to boost the immune response against RSV, a virus causing respiratory infections, in individuals who have had lung or kidney transplants. The goal is to evaluate the vaccine's effectiveness and safety for these individuals. Participants must have received a transplant more than a year ago, be on medication to prevent organ rejection, and have stable organ function. This study may suit those who participated in an earlier related study and are willing to follow specific trial procedures. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications to join the trial?

The trial does not specify that you need to stop taking your current medications. However, you must not use any investigational or non-registered products 30 days before and during the study, and you must continue your maintenance immunosuppressive therapy if you have had a transplant.

Is there any evidence suggesting that the adjuvanted RSVPreF3 vaccine is likely to be safe for humans?

Research has shown that the adjuvanted RSVPreF3 vaccine is generally well-tolerated. In studies involving individuals aged 60 and older, the vaccine proved to be safe. Participants exhibited a good immune response, with their bodies reacting as expected and showing strong responses from key immune cells that combat infections. Some participants experienced side effects, but these were typically mild.

If the FDA approves the vaccine for other uses, it reflects a level of safety confidence from those approvals. This trial, currently in an early phase, aims to assess the vaccine's safety in individuals who have undergone lung or kidney transplants. Ongoing studies will provide further information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The adjuvanted RSVPreF3 vaccine is unique because it combines an adjuvant with a recombinant protein to boost immunity against the Respiratory Syncytial Virus (RSV). Unlike traditional vaccines, which may rely solely on weakened or inactivated viruses, this vaccine enhances the immune response, potentially offering stronger protection, especially for immunocompromised individuals like lung or kidney transplant recipients. Researchers are excited about this treatment because it could offer a more robust defense against RSV, which is crucial for those undergoing chronic immunosuppressive therapy who are more vulnerable to severe respiratory infections.

What evidence suggests that the adjuvanted RSVPreF3 vaccine might be an effective treatment for RSV in lung or kidney transplant recipients?

Research has shown that the adjuvanted RSVPreF3 vaccine effectively prevents serious illness from respiratory syncytial virus (RSV). In earlier studies, the vaccine was 92% effective in preventing hospital visits and severe respiratory infections related to RSV in older adults. Another study found it reduced the risk of RSV-related lower respiratory tract disease requiring medical care by 77.5%. This indicates that the vaccine significantly lowers the chances of severe RSV infections needing medical attention. Although its effectiveness may decrease over time, the initial protection remains strong. Participants in this trial, specifically lung or kidney transplant recipients undergoing chronic immunosuppressive therapy, will receive a revaccination dose of the adjuvanted RSVPreF3 vaccine. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 who've had a lung or kidney transplant more than a year ago can join this study. They must be on drugs to prevent organ rejection, have been part of the RSV OA=ADJ-023 study, and agree to use birth control. Pregnant women or those able to get pregnant cannot participate.

Inclusion Criteria

I have given my written consent to participate in the study.

I am a kidney transplant patient.

I have used reliable birth control for at least one month before starting the study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Revaccination

Participants receive a revaccination dose of the adjuvanted RSVPreF3 vaccine

1 day

1 visit (in-person)

Safety Monitoring

Participants are monitored for safety and immunogenicity following revaccination

7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

365 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adjuvanted RSVPreF3 vaccine

Trial Overview The trial is testing how long the immune response lasts after getting an adjuvanted RSV vaccine and checks safety and immune response when given again. Participants previously vaccinated in another RSV study are revaccinated with the same vaccine.

How Is the Trial Designed?

Group I: IC Revaccination Group Experimental Treatment 1 Intervention

Lung or kidney transplant recipients undergoing chronic immunosuppressive therapy who received 1 and 2 doses of the adjuvanted RSVPreF3 vaccine (IC\_1 and IC\_2 groups respectively) in the RSV OA=ADJ-023 parent study will receive a revaccination dose of adjuvanted RSVPreF3 vaccine at Visit 1 (Day 1) in the current study.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf496/8293665

Estimated Vaccine Effectiveness for Respiratory Syncytial ... The RSVpreF vaccine was 92% effective against both RSV-related ARI ED visits/hospitalizations and severe ARI in this older adult real-world ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11633215/

Cost-effectiveness of the adjuvanted RSVPreF3 vaccine ... These vaccine efficacy values are projected to wane to 19.6% against RSV-ARI and 28.2% against RSV-LRTD by month 60. 95% confidence intervals ( ...

3. thelancet.com thelancet.com/journals/lanres/article/PIIS2213-2600(25)00048-7/abstract

Efficacy, safety, and immunogenicity of ... Cumulative efficacy over three seasons of one RSVPreF3 OA dose was 62·9% (97·5% CI 46·7–74·8) against RSV-LRTD, 69·8% (42·2–85·7) against RSV A- ...

4. cdc.gov cdc.gov/acip/grade/GSK-Adjuvanted-RSVPreF3-adults.html

GSK RSVPreF3 Vaccine (AREXVY) | ACIP GSK RSVPreF3 also reduced the risk of medically attended RSV LRTD (vaccine efficacy: 77.5% [95% CI: 57.9%, 89.0%]) (Table 3b). The trial was not ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673624017380

Respiratory syncytial virus (RSV) vaccine effectiveness ... This study found respiratory syncytial virus vaccination was 75% against respiratory syncytial virus-associated hospitalisation. To inform ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1198743X2500463X

Safety and immunogenicity of adjuvanted respiratory ... The adjuvanted RSVPreF3 vaccine was immunogenic and well tolerated with modest seroconversion but robust CD4+ T-cell responses. These data ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40245915/

Efficacy, safety, and immunogenicity of the AS01 E - ... A single RSVPreF3 OA dose was efficacious against RSV-LRTD over three RSV seasons in people aged 60 years or older, despite a decrease in efficacy over time.

8. academic.oup.com academic.oup.com/cid/article/78/6/1732/7585312

Efficacy and Safety of Respiratory Syncytial Virus (RSV ... One RSVPreF3 OA dose was efficacious against respiratory syncytial virus (RSV)–related lower respiratory tract disease during at least 2 RSV seasons in ≥60.