RSV Vaccine for Respiratory Infections

(RSV OA=ADJ-023 Trial)

No longer recruiting at 55 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: Cardiovascular, Hepatic, Neurological, Dementia, 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: 6

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new RSV vaccine to evaluate its effectiveness and safety, particularly in individuals with weakened immune systems. The researchers aim to determine whether one or two doses of the vaccine enhance the immune response in those who have undergone lung or kidney transplants. Participants who have had a stable lung or kidney transplant for over a year, or healthy adults managing conditions like diabetes or high blood pressure, might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, if you are on investigational or non-registered products, you should not have used them 30 days before the trial starts. Also, if you are on certain immune-modifying drugs, you may need to stop them up to 3 to 6 months before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the RSVPreF3 OA vaccine was safe in earlier studies. For example, one study found that less than 1% of people who received a single dose experienced any issues. Another study demonstrated that a second dose given a year later was also safe, with no major negative reactions.

These results suggest that the vaccine is generally safe for people with healthy immune systems. Although this trial focuses on individuals who have had lung or kidney transplants, existing research provides some confidence in the vaccine's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for respiratory infections?

Researchers are excited about the RSVPreF3 OA investigational vaccine because it offers a new approach to preventing RSV (respiratory syncytial virus) infections, especially in immunocompromised individuals, like transplant recipients. Unlike typical RSV treatments, which often manage symptoms rather than prevent the infection, this vaccine aims to prime the immune system to fend off the virus before it causes illness. The investigational vaccine is being tested in both single and multiple dose regimens, which could provide flexibility in vaccination strategies depending on patient needs. This proactive strategy is hoped to provide better protection for those who are most vulnerable to severe RSV-related complications.

What evidence suggests that the RSVPreF3 OA investigational vaccine might be an effective treatment for respiratory infections?

Research has shown that the RSVPreF3 OA vaccine can help prevent respiratory infections caused by the RSV virus. One study found a single dose of this vaccine to be 67.2% effective in preventing lower respiratory tract disease (LRTD) from RSV and 78.8% effective against severe cases of RSV-LRTD. Another study confirmed the vaccine's safety and effectiveness in preventing RSV-related respiratory infections. In this trial, participants in different arms will receive either one or two doses of the RSVPreF3 OA investigational vaccine. This vaccine targets a specific part of the virus to help the body build defenses against it. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Adults aged 50 or older who have had a lung or kidney transplant and are on immunosuppressive therapy can join this trial. It's also open to healthy adults over 50. Participants should be able to follow the study plan, not be pregnant, and use contraception if of childbearing potential. Exclusions include severe illnesses that could interfere with the study, recent organ rejection, certain infections like HIV or CMV, multiple organ transplants (except double kidney/lung), and unstable chronic diseases.

Inclusion Criteria

I have a stable chronic condition like diabetes or heart disease.

I am a woman who cannot become pregnant due to surgery or menopause.

I live independently or in a place with minimal help and can take care of myself.

Exclusion Criteria

I do not have a fever or serious illness right now.

I am currently being treated for a recent organ rejection.

I have not taken high doses of steroids, except for inhaled, topical, or joint injections, in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 or 2 doses of the RSVPreF3 OA investigational vaccine

8-12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

50-54 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RSVPreF3 OA Investigational Vaccine

Trial Overview The RSVPreF3 OA investigational vaccine is being tested for its effectiveness in triggering an immune response against Respiratory Syncytial Virus (RSV) in those with weakened immune systems due to lung or kidney transplants compared to healthy adults. The study will assess safety and whether a second dose improves immunity.

How Is the Trial Designed?

Group I: RSV_IC_2 group Experimental Treatment 1 Intervention

IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).

Group II: RSV_IC_1 group Experimental Treatment 1 Intervention

Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).

Group III: RSV_HA group Active Control 1 Intervention

Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).

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

Published Research Related to This Trial

The RSVPreF3 vaccine combined with the AS01 adjuvant significantly boosted RSV-neutralizing antibody responses and T cell responses in both mice and cattle, indicating its potential effectiveness for older adults.

In both animal models, the RSVPreF3/AS01 formulation outperformed non-adjuvanted versions in generating stronger immune responses, suggesting it is a promising candidate for further clinical evaluation as a vaccine for RSV in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. Bouzya, B., Rouxel, RN., Sacconnay, L., et al.[2023]

The RSVPreF3 vaccine candidate from GSK is designed to protect both young children and older adults against respiratory syncytial virus (RSV), with different vaccination strategies for each age group.

In toxicity studies involving rabbits and rats, the RSVPreF3 vaccine was found to be well-tolerated, showing only mild inflammatory reactions and no adverse effects on female fertility or the development of offspring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated Dose Toxicity Study and Developmental and Reproductive Toxicology Studies of a Respiratory Syncytial Virus Candidate Vaccine in Rabbits and Rats. Stokes, AH., Franklin, K., Fisher, DE., et al.[2022]

The study involving 48 young adults and 1005 older adults demonstrated that the RSVPreF3 vaccine significantly boosted immune responses, particularly after the first dose, with higher levels of RSV-specific antibodies and T cells observed in participants receiving the AS01-adjuvanted formulation.

Safety assessments revealed that most side effects were mild to moderate and temporary, with no significant safety concerns identified, leading to the selection of the AS01E-adjuvanted vaccine for further clinical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial. Leroux-Roels, I., Davis, MG., Steenackers, K., et al.[2023]

The RSVPreF3 vaccine candidate was found to be safe for use in 213 healthy pregnant women, with no significant adverse events related to the vaccine or placebo reported during the study.

The vaccine effectively increased RSV-specific neutralizing antibody levels in mothers and successfully transferred these antibodies to newborns, indicating strong immunogenicity and potential protection for infants against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. Bebia, Z., Reyes, O., Jeanfreau, R., et al.[2023]

The RSVPreF3 OA vaccine demonstrated high efficacy against RSV-related lower respiratory tract disease (94.6%) and acute respiratory illness (81.0%) in older adults with coexisting cardiorespiratory or endocrine/metabolic conditions, indicating it is effective for those at higher risk.

Immunogenicity results showed that post-vaccination neutralizing antibody levels in participants with these conditions were comparable to those without, suggesting that the vaccine is safe and effective across different health statuses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. Feldman, RG., Antonelli-Incalzi, R., Steenackers, K., et al.[2023]

In a study involving 122 older adults, a third dose of the RSVPreF3-AS01E vaccine was found to be well tolerated, with mostly mild-to-moderate side effects and no serious adverse events reported, indicating a good safety profile.

The third dose significantly boosted RSV-specific neutralizing antibodies and T-cell responses, demonstrating its immunogenicity, although the antibody levels after the third dose were lower than those observed one month after the first dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. Leroux-Roels, I., Van Ranst, M., Vandermeulen, C., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38253338/

Efficacy and Safety of Respiratory Syncytial Virus (RSV) ... Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI: 48.2-80.0%) against RSV-LRTD and 78.8% (95% CI: 52.6-92.0%) against severe ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209604

Respiratory Syncytial Virus Prefusion F Protein Vaccine in ... A single dose of the RSVPreF3 OA vaccine had an acceptable safety profile and prevented RSV-related acute respiratory infection and lower respiratory tract ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04886596

NCT04886596 | Efficacy Study of GSK's Investigational ... This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in ...

4. 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- ...

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

Efficacy and Safety of Respiratory Syncytial Virus (RSV ... Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI: 48.2–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.6–92.0%) against severe RSV-LRTD.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06389487

NCT06389487 | A Study on the Immune Response and ... The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260025000487

Articles Efficacy, safety, and immunogenicity of the AS01 E ... RSVPreF3 OA showed a clinically acceptable safety profile. Between dose one and trial end, eight (<1%) participants in the RSV single-dose group, 12 (<1%) in ...