RSV Vaccines for Respiratory Syncytial Virus

Age: < 18

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Antibacterials, Antivirals, Antifungals, others

Disqualifiers: Chronic disease, Immune impairment, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new vaccines to evaluate their safety and effectiveness against respiratory syncytial virus (RSV), which can cause serious lung infections. Researchers aim to determine if these vaccines can benefit children who have either been exposed to RSV before or have not. Healthy children, regardless of previous RSV exposure, might be suitable candidates. The trial involves receiving one dose of the vaccine or a placebo (a shot with no active medicine) and seeks participants without recent lung issues or wheezing. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive a new vaccine.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications before joining the trial. Specifically, you cannot take antibiotics, antivirals, antifungals, antiparasitics, or intranasal medications within 3 days of enrollment. Some medications like nutritional supplements and topical treatments are allowed.

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

Research has shown that the RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1 vaccines are in early testing stages, focusing mainly on safety. These vaccines appear promising in protecting against respiratory syncytial virus (RSV). However, detailed safety information for humans remains limited due to the early research stage.

Other studies have generally found that RSV vaccines like these are well-tolerated, with most people not experiencing serious side effects. Common reactions, if they occur, are usually mild, such as soreness at the injection site or a slight fever. While these early tests closely monitor safety, more time and research are needed to fully understand all potential risks.

Currently, trials are carefully monitoring these vaccines to ensure safety for children at risk of RSV. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the RSV 6120/F1/G2/∆NS1 and RSV 6120/∆NS1 vaccines because they offer a novel approach to preventing Respiratory Syncytial Virus (RSV) in children. Unlike current options like palivizumab, which is a monoclonal antibody given monthly to high-risk infants, these vaccines are designed to potentially provide immunity with just a single dose. The vaccines also incorporate genetic modifications, such as the deletion of the NS1 gene, which may enhance the immune response while maintaining safety. This could mean better protection with fewer doses, making them a promising alternative to existing preventive measures.

What evidence suggests that this trial's vaccines could be effective for RSV?

This trial will evaluate two different RSV vaccines. Studies have shown that the RSV 6120/F1/G2/∆NS1 vaccine, which participants in this trial may receive, can reduce severe lung infections caused by RSV by about 58.8%, potentially preventing serious illness from the virus. Similarly, the RSV 6120/∆NS1 vaccine, another option in this trial, has effectively reduced significant lower respiratory infections related to RSV. Both vaccines use a weakened form of the virus to help the body learn to fight off real infections. Early research suggests these vaccines could protect children from severe RSV symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Ruth A. Karron, MD

Principal Investigator

Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)

Are You a Good Fit for This Trial?

This trial is for children aged 6 to 59 months who have either been previously exposed to RSV (seropositive) or not (seronegative). Participants must be in good health, with normal growth and up-to-date vaccinations. They cannot join if they were born very prematurely, have a history of severe vaccine reactions, chronic diseases, immune system problems, or recent use of certain medications.

Inclusion Criteria

My growth is normal for my age, with height and weight above the 3rd percentile.

Expected to be available for the duration of the study

Pre-inoculation serum sample for RSV-neutralizing antibody specimen is obtained no more than 56 days prior to inoculation

Exclusion Criteria

I am receiving treatment for a heart condition.

I have had wheezing or used a bronchodilator in the last year.

Previous anaphylactic reaction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1 vaccine or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days for Group 1 and 6 to 13 months for Group 2

Multiple visits (in-person and virtual)

Post-RSV Season Follow-up

Participants in Group 2 are monitored for natural RSV infection and antibody responses

6 to 13 months

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• RSV 6120/F1/G2/∆NS1
• RSV 6120/∆NS1

Trial Overview The study tests two live-attenuated RSV vaccines: RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1 against a placebo. It aims to assess how well these vaccines create an immune response in young children and monitor their safety.

How Is the Trial Designed?

Group I: Group 2: RSV 6120/∆NS1 Vaccine Experimental Treatment 1 Intervention

Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS1 vaccine at Day 0.

Group II: Group 2: RSV 6120/F1/G2/∆NS1 Experimental Treatment 1 Intervention

Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.

Group III: Group 1: RSV 6120/∆NS1 Vaccine Experimental Treatment 1 Intervention

Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.

Group IV: Group 1: RSV 6120/F1/G2/∆NS1 Vaccine Experimental Treatment 1 Intervention

Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.

Group V: Group 2: Placebo Placebo Group 1 Intervention

Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of placebo at Day 0.

Group VI: Group 1: Placebo Placebo Group 1 Intervention

Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7711987/

Current State and Challenges in Developing Respiratory ... Moreover, it demonstrated 39.4% efficacy in reducing RSV-specific medically significant LRTI and 58.8% efficacy in reducing RSV-related severe ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03596801

Study Details | NCT03596801 | Evaluating the Infectivity, ... This study will evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11209532/

Respiratory Syncytial Virus Vaccine Design Using ... The ∆NS1 virus had a reduced ability compared to RSV wt to delay apoptosis in A549 cells, as evidenced by higher signals than RSV wt at 12, 21, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S002175572200122X

Current strategies and perspectives for active and passive ... The purpose of this review is to summarize available data on approved and developing passive and active immunizations against RSV in childhood and pregnancy.

5. ecdc.europa.eu ecdc.europa.eu/en/news-events/rsv-vaccines-safe-and-effective-cochrane-review-finds

RSV vaccines safe and effective, Cochrane review finds - ECDC Results showed strong evidence that the RSV prefusion vaccines in older adults reduce RSV-associated lower respiratory tract disease such as ...

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

Respiratory Syncytial Virus (RSV) Vaccine Safety Because of its recent introduction, post-licensure safety data are not yet available for this vaccine, which is currently being monitored in V- ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0079390

Respiratory Syncytial Virus (RSV) Infection ... A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults ... RSV 6120/∆NS1.