RSV/hMPV Vaccine for Respiratory Infections

Not currently recruiting at 12 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Anticoagulants, others

Disqualifiers: Immunodeficiency, Myocarditis, Substance abuse, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and immune response of a new vaccine for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in older adults. Participants receive either the RSV/hMPV vaccine candidate or a placebo to evaluate the vaccine's effectiveness and potential side effects. The trial also examines the benefits of a booster shot after one year. Individuals aged 60 and older, with stable health conditions that haven't required recent hospital visits or major medication changes, may qualify for this study. As a Phase 1, Phase 2 trial, it focuses on understanding the treatment's function in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or anticoagulants, you may not be eligible to participate. It's best to discuss your specific medications with the trial investigator.

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

Research has shown that earlier studies tested the RSV/hMPV vaccine for safety. Initial results indicate that the vaccine is generally well-tolerated. Most reported side effects were mild, such as soreness at the injection site or a mild fever, which are common with many vaccines. However, one study found that a few participants who received the combination vaccine needed hospitalization due to issues related to hMPV. While these cases were rare, they are important to consider.

Since this trial includes a booster dose, the safety of repeated doses is also under study. As the vaccine remains in the early testing phases, not all potential risks are fully known. Always consult healthcare professionals when considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for respiratory infections like RSV (Respiratory Syncytial Virus) and hMPV (Human Metapneumovirus) rely on supportive care and antiviral medications. However, this new RSV/hMPV vaccine candidate stands out because it aims to prevent infections rather than just treat symptoms. Unlike current treatments, which often involve managing symptoms after infection has occurred, this vaccine works by stimulating the immune system to recognize and fight off these viruses before they cause illness. Researchers are excited about this vaccine because it could reduce the incidence and severity of these respiratory infections, providing a proactive solution where currently there are limited preventive options.

What evidence suggests that this trial's RSV/hMPV vaccine candidate could be effective for respiratory infections?

Research has shown that the RSV/hMPV vaccine candidate, which participants in this trial may receive, has promising results from earlier studies. It was well-tolerated and helped adults aged 60 to 75 develop specific antibodies against RSV and hMPV. This indicates that the vaccine prepared their immune systems to combat these viruses. Studies in animals, such as cotton rats, demonstrated that the vaccine could produce high levels of antibodies crucial for preventing infections. Overall, these findings suggest the vaccine might protect against respiratory infections caused by RSV and hMPV. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 60 or older can join this vaccine study if they're not pregnant, breastfeeding, and don't have a history of severe allergies to the vaccine's ingredients. They should be generally healthy or have stable chronic diseases. People with recent serious infections, heart inflammation history, bleeding disorders, or on certain medications may not qualify.

Inclusion Criteria

I am not pregnant, breastfeeding, and cannot become pregnant.

My doctor agrees I am fit for the trial and my condition has been stable without major treatment changes for 6 weeks.

I am 60 years old or older.

Exclusion Criteria

Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure

I have a weak immune system or I am taking medication that weakens my immune system, but I am stable if I have HIV.

I have not had COVID-19 or its symptoms in the last 10 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular (IM) injection of the RSV/hMPV vaccine candidate or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity for 12 months post-vaccination

12 months

Multiple visits (in-person and virtual)

Booster

A subset of participants receive a booster vaccination 12 months after the primary vaccination

1 day

1 visit (in-person)

Booster Follow-up

Participants are monitored for safety and immunogenicity for 12 months after the booster dose

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• RSV/hMPV vaccine candidate

Trial Overview The trial is testing different doses of an RSV/hMPV vaccine candidate in seniors to see how safe it is and how well it works (immunogenicity). Participants will get one shot and some will receive a booster after 12 months. A placebo group is included for comparison.

How Is the Trial Designed?

Group I: Sentinel Cohort: RSV/hMPV Group 2 (Dose B) Experimental Treatment 1 Intervention

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Group II: Sentinel Cohort: RSV/hMPV Group 1 (Dose A) Experimental Treatment 1 Intervention

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Group III: Sentinel Cohort: RSV/hMPV Group 0 (Dose L) Experimental Treatment 1 Intervention

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Group IV: Main Cohort: RSV/hMPV Group 2 (Dose B) Experimental Treatment 1 Intervention

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Group V: Main Cohort: RSV/hMPV Group 1 (Dose A) Experimental Treatment 1 Intervention

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Group VI: Booster Cohort-RSV/hMPV Experimental Treatment 2 Interventions

Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort

Group VII: Main Cohort: Placebo-Group 3 Placebo Group 1 Intervention

Participants will be randomized to receive a single IM injection of placebo

Group VIII: Booster Cohort-Placebo Placebo Group 1 Intervention

Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort

Group IX: Sentinel Cohort: Placebo-Group 3 Placebo Group 1 Intervention

Participants will be randomized to receive a single IM injection of placebo

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Published Research Related to This Trial

The Ad26.RSV.preF vaccine candidate showed good safety and immunogenicity in a study involving 12 adults and 36 RSV-seropositive children, with no serious adverse events reported and only mild to moderate reactions observed.

The vaccine significantly increased RSV neutralization titers in children and resulted in fewer RSV infections compared to the placebo group, indicating its potential effectiveness in preventing RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. Stuart, ASV., Virta, M., Williams, 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 historical use of a formalin-inactivated RSV vaccine in the 1960s led to enhanced respiratory disease in infants, highlighting the need to understand the immunological mechanisms behind this adverse effect before developing new vaccines.

Recent discussions among experts and the FDA suggest that if new candidate vaccines demonstrate safety in preclinical and early clinical studies, they may be tested in RSV-naïve infants, marking a potential advancement in preventive measures against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Summary of the Vaccines and Related Biological Products Advisory Committee meeting held to consider evaluation of vaccine candidates for the prevention of respiratory syncytial virus disease in RSV-naïve infants. Browne, SK., Beeler, JA., Roberts, JN.[2021]

The study evaluated an adjuvanted RSV vaccine in 1900 adults aged 60 and older, using a reliable patient-reported outcome tool (FLU-PRO) to assess RSV disease symptoms and virologic confirmation, demonstrating the tool's effectiveness in capturing relevant data.

Self-collection of nasal swabs significantly improved the detection of RSV cases, identifying 9 additional cases that site-swabbing alone would have missed, highlighting the importance of participant engagement in monitoring respiratory illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Efficacy Endpoints for a Phase IIb Study of a Respiratory Syncytial Virus Vaccine in Older Adults Using Patient-Reported Outcomes With Laboratory Confirmation. Yu, J., Powers, JH., Vallo, D., et al.[2020]

The bivalent RSVpreF vaccine was found to be safe and well-tolerated in a study of 618 adults aged 18-49, with mostly mild or moderate local and systemic reactions and no serious adverse events reported within 12 months post-vaccination.

The vaccine induced strong virus-neutralizing responses, with antibody levels significantly higher than those needed for protection in high-risk infants, suggesting its potential effectiveness for maternal immunization against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. Walsh, EE., Falsey, AR., Scott, DA., et al.[2022]

Respiratory syncytial virus (RSV) is a significant cause of illness and death in children, highlighting the urgent need for an effective vaccine.

Recent advancements in molecular technologies have improved the safety of live-attenuated vaccines, and protein-based vaccines are showing promise in clinical trials for both RSV-primed individuals and maternal vaccination to protect infants early in life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory syncytial virus vaccine: Is it coming? Sales, V., Wang, EE.[2021]

Human metapneumovirus (HMPV) is a significant cause of respiratory infections in infants, and despite extensive research, no effective vaccines for HMPV or respiratory syncytial virus (RSV) have been developed in over 50 years.

Recombinant chimeric viruses that express antigens from HMPV and other viruses show promise as potential vaccine candidates, with ongoing studies validating their effectiveness and suggesting optimization strategies based on RSV research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engineering of Live Chimeric Vaccines against Human Metapneumovirus. Ogonczyk Makowska, D., Hamelin, MÈ., Boivin, G.[2020]

The Gcf A/Bac M2 vaccine candidate successfully induced strong Th1 and CD8+ T-cell responses in mice, leading to effective protective immunity against respiratory syncytial virus (RSV) without causing vaccine-enhanced disease (VED).

This vaccine formulation also resulted in a significant increase in IgG responses compared to Gcf A alone, suggesting that Bac M2 acts as an effective adjuvant, enhancing the immune response to RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine containing G protein fragment and recombinant baculovirus expressing M2 protein induces protective immunity to respiratory syncytial virus. Jo, YM., Kim, J., Chang, J.[2022]

The investigational ChAd155-RSV vaccine was found to have a safety profile similar to other childhood vaccines, with most adverse events occurring at rates comparable to or lower than those of active comparators.

The vaccine induced a strong immune response in infants, with higher RSV neutralizing titers and antibody concentrations compared to the comparator group, and there was no evidence of vaccine-associated enhanced respiratory disease (VAERD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6-7 months of age: a phase 1/2 randomized trial. Sáez-Llorens, X., Norero, X., Mussi-Pinhata, MM., et al.[2023]

Respiratory syncytial virus (RSV) poses a significant health risk not only to infants but also to older adults, prompting urgent vaccine development efforts, with 19 candidates currently in clinical trials.

Advancements in understanding the RSV surface fusion glycoprotein have led to innovative vaccine strategies, including particle-based, live-attenuated, subunit, and vector-based approaches, although past trial failures indicate the need for improved knowledge on immunological protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The respiratory syncytial virus vaccine landscape: lessons from the graveyard and promising candidates. Mazur, NI., Higgins, D., Nunes, MC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11977332/

A Randomized Phase 1 Clinical Trial of a Respiratory ... IVX-A12 was well-tolerated and elicited RSV- and hMPV-specific antibody responses in adults 60–75 years of age. These data support the ongoing ...

2. nature.com nature.com/articles/s41541-025-01231-9

Metavac-RSV mucosal bivalent vaccine candidate protects ... In summary, we have shown that vaccination of cotton rats with Metavac®-RSV induced the production of high levels of neutralizing antibodies ...

3. publications.aap.org publications.aap.org/pediatrics/article/156/3/e2024070218/203034/Human-Metapneumovirus-and-Respiratory-Syncytial

Human Metapneumovirus and Respiratory Syncytial Virus ... Children presenting to the ED with RSV-associated acute respiratory illness had higher odds of being hospitalized than children with HMPV (aOR, ...

4. mdpi.com mdpi.com/2076-393X/13/6/569

Vaccine Development for Human Pneumoviruses Recent advancements include the approval of three RSV vaccine candidates: AREXVY ® (GSK), ABRYSVO ® (Pfizer), and mRESVIA ® (Moderna).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11187144/

Mucosal bivalent live attenuated vaccine protects against ... Mucosal bivalent live attenuated vaccine protects against human metapneumovirus and respiratory syncytial virus in mice

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06583031

NCT06583031 | Study to Evaluate the Safety and Immune ... Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human ...

7. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/312867/study-of-a-respiratory-2/

Study on Safety and Immune Response of RSV and hMPV ... This study investigates the safety and immune response of a vaccine candidate for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in adults ...

8. fda.gov fda.gov/media/184380/download

Imbalance in Severe Respiratory Syncytial Virus (RSV) ... • Preliminary data: 3 hMPV cases in combined RSV+hMPV vaccine recipients required hospitalization. • 2 cases in RSV+hMPV (7.5 µg RSV + 7.5 µg ...