RSV Vaccine for Respiratory Infections

(RSV OA=ADJ-023 Trial)

Recruiting at 50 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

387 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the RSVPreF3 OA investigational vaccine treatment for respiratory infections?

The RSVPreF3 OA vaccine has shown effectiveness in older adults, particularly those with existing health conditions, by reducing the risk of severe respiratory illness caused by RSV. Studies have demonstrated that the vaccine is well-tolerated and boosts immune responses, making it a promising option for preventing RSV-related diseases. ^{1 2 3 4 5}

How is the RSVPreF3 OA investigational vaccine different from other treatments for respiratory infections?

The RSVPreF3 OA investigational vaccine is unique because it uses a stabilized prefusion conformation of the RSV fusion protein, which is designed to elicit a stronger immune response, especially in older adults. It is also adjuvanted with AS01E to enhance its effectiveness, particularly for those with weakened immune systems. ^{1 2 3 4 6}

What is the purpose of this trial?

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: RSV_IC_2 group Experimental Treatment 1 Intervention

Immunocompromised (IC) patients receiving 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) patients receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).

Group III: RSV_HA group Active Control 1 Intervention

Healthy participants receiving 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

Findings from Research

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]

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]

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 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 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]

References

1. United States 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. [2023]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. [2023]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. [2023]

6. United States 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. [2023]