RSV/hMPV Vaccines for RSV and hMPV Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests vaccines that might prevent infections from two common viruses: RSV and hMPV, which can cause cold-like symptoms. The study aims to determine the safety of these vaccines and how well the body responds to them. Researchers will test different formulations and doses, including the hMPV Vaccine and the RSV/hMPV Combination Vaccine, on adults aged 18-49 and 60-80, to identify the most promising option. Ideal participants are healthy, fall within the specified age ranges, and have not had a confirmed RSV or hMPV infection in the past year. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking vaccine development.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found the RSV/hMPV combination vaccine well-tolerated by adults aged 60 to 85. Most side effects were mild, such as soreness at the injection site or mild flu-like symptoms. Another study confirmed the vaccine's safety for adults aged 60 to 75.
Research on the hMPV vaccine also showed it was well-tolerated. Participants experienced manageable, non-severe side effects, with mild pain at the injection site being the most common issue.
These findings suggest both vaccines are generally safe for adults, with the most common side effects being mild and minimal.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these RSV/hMPV and hMPV vaccines because they offer a new way to prevent infections from both the respiratory syncytial virus (RSV) and the human metapneumovirus (hMPV). Unlike traditional treatments that focus on managing symptoms after infection, these vaccines aim to prevent the diseases from occurring in the first place. The RSV/hMPV combination vaccine is particularly promising as it targets two viruses simultaneously, potentially providing broader protection with just one shot. Additionally, the vaccines are being tested at various dosages, which could help optimize their efficacy and safety for different age groups, offering a tailored approach to prevention.
What evidence suggests that this trial's vaccines could be effective for RSV and hMPV infections?
Studies have shown that the RSV/hMPV combination vaccine, which trial participants may receive, is safe and helps the body build defenses against both RSV and hMPV. This boosts the body's ability to fight these viruses. In older adults, a successful combination vaccine could reduce illnesses and deaths caused by these respiratory viruses. Although no approved vaccines for hMPV exist yet, research suggests it can greatly lower the chance of respiratory infections. This trial will also evaluate the hMPV vaccine, which aims to protect people from serious breathing problems linked to hMPV.12567
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18–49 and healthy or stable adults aged 60–80, with a BMI between 18 and 33. Participants must be able to follow study instructions, use electronic devices for reporting, and give written consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of the investigational RSV/hMPV or hMPV vaccine or control/placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment, including solicited and unsolicited adverse events
Extended Follow-up
Participants in selected formulation groups are monitored for serious adverse events
What Are the Treatments Tested in This Trial?
Interventions
- hMPV Vaccine
- RSV/hMPV Combination Vaccine
Trial Overview
The study is testing different doses of new vaccines against RSV and hMPV—some target both viruses together, others just hMPV. There are also control vaccines and placebos. The goal is to see how safe the vaccines are and how well they trigger an immune response in younger and older adults.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
Placebo Group
YA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1.
OA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1.
YA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1.
OA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1.
YA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1.
OA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1.
OA participants receive a single dose of hMPV\_Y medium dose vaccine in both Phase 1 and Phase 2, at Day 1.
OA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 1, at Day 1.
YA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, at Day 1.
OA participants receive a single dose of hMPV\_Y high dose vaccine in both Phase 1 and Phase 2, at Day 1.
YA participants receive a single dose of RSV/hMPV\_X medium dose vaccine in Phase 1, at Day 1.
OA participants received a single dose of RSV/hMPV\_X medium dose vaccine in both Phase 1 and Phase 2, at Day 1.
YA participants receive a single dose of RSV/hMPV\_X low dose vaccine in Phase 1, at Day 1.
OA participants receive a single dose of RSV/hMPV\_X low dose vaccine in both Phase 1 and Phase 2, at Day 1.
YA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 1, at Day 1.
OA participants receive a single dose of RSV/hMPV\_X high dose vaccine in both Phase 1 and Phase 2, at Day 1.
OA participants receive a single dose of RSV/hMPV\_W medium dose vaccine in both Phase 1 and Phase 2, at Day 1.
OA participants receive a single dose of RSV/hMPV\_W low dose vaccine in both Phase 1 and Phase 2, at Day 1.
OA participants receive a single dose of RSV/hMPV\_W high dose vaccine in both Phase 1 and Phase 2, at Day 1.
OA participants receive a single dose of RSV/hMPV\_V medium dose vaccine in both Phase 1 and Phase 2, at Day 1.
OA participants receive a single dose of RSV/hMPV\_V low dose vaccine in both Phase 1 and Phase 2, at Day 1.
OA participants receive a single dose of RSV/hMPV\_V high dose vaccine in both Phase 1 and Phase 2, at Day 1.
OA participants receive a single dose of control vaccine in both Phase 1 and Phase 2, at Day 1.
YA participants receive a single dose of control vaccine in Phase 1, at Day 1.
OA participants receive a single dose of placebo in both Phase 1 and Phase 2, at Day 1.
YA participants receive a single dose of placebo in Phase 1, at Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
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
Citations
A Randomized Phase 1 Clinical Trial of a Respiratory ... - PMC
This first-in-human trial of an RSV/hMPV combination VLP vaccine demonstrated that IVX-A12 was well-tolerated in adults 60–75 years of age, had ...
A Phase IIa randomized clinical trial of a respiratory ...
Overall, the safety and immunogenicity data from this Phase IIa trial demonstrate the feasibility of a combination vaccine against RSV and hMPV.
Preliminary analysis of combined vaccines against ...
The results showed that both vaccines increased neutralizing antibody titers against RSV-A and RSV-B, and hMPV in children aged 5–8 months and 8–23 months
Brothers in arms: RSV and hMPV
hMPV poses a substantial clinical and public health burden among children and older adults, similar to respiratory syncytial virus (RSV).
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vaccineadvisor.com
vaccineadvisor.com/news/comorbidities-worsen-outcomes-in-rsv-influenza-hmpv-related-pneumonia/Comorbidities Worsen Outcomes in RSV, Influenza, hMPV ...
Overall, the rate of pneumonia was 62%, in which fewer patients with RSV had pneumonia (~50%) than those with influenza (~66%) or hMPV (~75%).
NCT07628049 | A Study of Investigational RSV/hMPV ...
The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination ...
Clover Announces Positive Phase I Clinical Data for RSV ...
Results indicate potential best-in-class RSV+hMPV±PIV3 combination vaccines, RSV vaccines are safe & effective, critical gaps persist globally, ...
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