RSV Challenge Strain for Healthy Adults

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Steroids, Immunosuppressants, Inhalers, others

Disqualifiers: Asthma, Pregnancy, HIV, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new nasal spray, rRSV A/Maryland/001/11, to assess its safety and effectiveness against RSV, a virus that causes lung infections. Researchers aim to understand the virus's behavior and the body's immune response. The trial targets healthy adults who feel well, have no recent asthma or breathing issues, and can remain in a study unit for the trial's duration. Participants should avoid close contact with young children or individuals with weakened immune systems. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using systemic or nasal steroid preparations, immunosuppressive drugs, and certain inhaled medications 30 days before the challenge. If you use nasal medications like decongestants or hormonal medications, you must stop 28 days before the study challenge.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the safety of the rRSV A/Maryland/001/11 virus has been studied in healthy adults. This virus is a specially-made version of RSV, which typically causes cold-like symptoms.

In these studies, researchers closely monitored participants to observe their reactions. As early-stage research, the focus was primarily on identifying any side effects. The treatment was generally well-tolerated, with most side effects being mild and similar to those of a common cold, such as a runny nose or sore throat.

Since this research remains in the early stages, the primary goal is to ensure its safety for humans. While some evidence of safety exists, further studies are necessary to fully understand its safety profile. So far, it appears to be tolerated without serious issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about rRSV A/Maryland/001/11 because it offers a new approach to tackling respiratory syncytial virus (RSV) infections. Unlike traditional vaccines that use inactivated or weakened forms of the virus, this treatment is a recombinant form, potentially offering enhanced safety and effectiveness. By targeting the virus in a novel way, it could provide better protection for healthy adults against RSV, which is known for causing severe respiratory illnesses. This innovative approach might pave the way for more effective prevention strategies against RSV.

What evidence suggests that this treatment might be an effective treatment for RSV?

Research shows that rRSV A/Maryland/001/11 is a modified version of the respiratory syncytial virus (RSV) used to study its safety and immune effects in healthy adults. Laboratory modifications allow the virus to grow and trigger an immune response. Early results suggest this approach helps researchers understand the body's defense mechanisms by observing immune reactions. Current studies, including this trial where participants receive a single dose of rRSV A/Maryland/001/11, examine the virus's ability to activate the immune system and its safety for participants. This research aims to aid in developing effective vaccines or treatments for RSV in the future. ^{1 2 3 4 6}

Who Is on the Research Team?

Kawsar Talaat, MD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

Healthy adults aged 18-50 can join this trial. They must be in good health, pass a test showing they understand RSV and the study, and stay at the hospital for the trial period. Participants need to use reliable birth control or be sterile.

Inclusion Criteria

General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator

Available for the duration of the trial

Willingness to refrain from receiving licensed or investigational vaccines or other investigational products from the day of enrollment until Study Day 56

Exclusion Criteria

I have received all required vaccines within the specified timeframes.

Receipt of any investigational vaccine or drug within specific timeframes

I have had my spleen removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Challenge

Participants are admitted to the inpatient isolation unit and receive a single dose of 10^5 PFUs of rRSV A/Maryland/001/11 intranasally on Day 0

8 days

Inpatient stay

Outpatient Follow-up

Participants attend outpatient visits for monitoring, including physical examinations, blood collection, and nasal washes

56 days

Visits on Days 10, 28, and 56

Long-term Follow-up

Follow-up phone contact at 6 months to assess for any new chronic conditions or serious health events/hospitalizations

What Are the Treatments Tested in This Trial?

Interventions

• rRSV A/Maryland/001/11

Trial Overview The trial is testing rRSV A/Maryland/001/11, a lab-made version of Respiratory Syncytial Virus (RSV). It's given through the nose to see how safe it is, if it causes an immune response, and how well it grows inside the body.

How Is the Trial Designed?

Group I: Cohort 2: rRSV A/Maryland/001/11 Experimental Treatment 1 Intervention

Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0).

Group II: Cohort 1: rRSV A/Maryland/001/11 Experimental Treatment 1 Intervention

Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (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. clinicaltrials.gov clinicaltrials.gov/study/NCT03624790?cond=Human%20respiratory%20syncytial%20virus&viewType=Table&rank=6

Inpatient Challenge Study of rRSV A/Maryland/001/11 ... This study will evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/90/NCT03624790/ICF_000.pdf

CONFIDENTIAL rRSV A/Maryland/001/11 Page 1 of 14 ... The purpose of this research project is to learn about the safety and immune (germ-fighting) response in healthy adults to the virus (germ) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11497170/

Inno4Vac Workshop Report Part 2: RSV‐Controlled Human ... Challenge material of this RSV A/Maryland/001/11 was generated using a reverse genetics (RG) system, generating a replication competent RSV that contains a ...

4. journals.asm.org journals.asm.org/doi/10.1128/jvi.01512-20

A Parainfluenza Virus Vector Expressing the Respiratory ... One additional RSV was rRSV A/Maryland/001/11, which is a recombinant version of the wt subgroup A strain RSV A/Maryland/001/11 that was isolated from a ...

5. malacards.org malacards.org/card/respiratory_syncytial_virus_infectious_disease

Respiratory Syncytial Virus Infectious Disease Integrated disease information for Respiratory Syncytial Virus Infectious Disease including associated genes, mutations, phenotypes, pathways, drugs, ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0079390

Respiratory Syncytial Virus (RSV) Infection ... Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers, No drug ...