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Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
Study details:
The study duration will be up to approximately 12 months minus the screening period.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 60 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-09-17
Primary completion: 2026-01-01
Study completion finish: 2026-01-08
Study type
PREVENTION
Phase
PHASE1
Trial ID
NCT06604767
Intervention or treatment
BIOLOGICAL: parainfluenza virus type 3 vaccine (PIV3)
BIOLOGICAL: RSV/hMPV/PIV3 vaccine
BIOLOGICAL: RSV/hMPV vaccine
BIOLOGICAL: RSV vaccine 1
BIOLOGICAL: RSV vaccine 2
Conditions
- • Respiratory Syncytial Virus Infection
- • Metapneumovirus Infection
- • Parainfluenzae Virus Infection
Find a site
Closest Location:
Investigational Site Number : 0360002
Research sites nearby
Select from list below to view details:
Investigational Site Number : 0360002
Camberwell, Victoria, Australia
Investigational Site Number : 0360001
Botany, New South Wales, Australia
Investigational Site Number : 0360009
Brookvale, New South Wales, Australia
Investigational Site Number : 0360004
Miranda, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: PIV3 Dose 1
| BIOLOGICAL: parainfluenza virus type 3 vaccine (PIV3)
|
EXPERIMENTAL: PIV3 Dose 2
| BIOLOGICAL: parainfluenza virus type 3 vaccine (PIV3)
|
EXPERIMENTAL: PIV3 Dose 3
| BIOLOGICAL: parainfluenza virus type 3 vaccine (PIV3)
|
EXPERIMENTAL: PIV3 Dose 4
| BIOLOGICAL: parainfluenza virus type 3 vaccine (PIV3)
|
EXPERIMENTAL: RSV/hMPV /PIV3 Formulation 1
| BIOLOGICAL: RSV/hMPV/PIV3 vaccine
|
EXPERIMENTAL: RSV/hMPV Formulation 1
| BIOLOGICAL: RSV/hMPV vaccine
|
EXPERIMENTAL: RSV/hMPV Formulation 2
| BIOLOGICAL: RSV/hMPV vaccine
|
EXPERIMENTAL: RSV vaccine 1
| BIOLOGICAL: RSV vaccine 1
|
EXPERIMENTAL: RSV vaccine 2
| BIOLOGICAL: RSV vaccine 2
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination | Number of participants experiencing immediate unsolicited systemic AEs | Within 30 minutes after each vaccination |
| Presence of solicited administration site reactions within 7 days after vaccination | Number of participants reporting: - injection site reactions: pain, erythema and swelling | Within 7 days after vaccination |
| Presence of solicited systemic reactions within 7 days after vaccination | Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills | Within 7 days after vaccination |
| Presence of unsolicited AEs within 28 days after vaccination | Number of participants experiencing unsolicited AEs | Within 28 days after vaccination |
| Presence of serious adverse events (SAEs) | Number of participants experiencing SAEs regardless of causality | Within 6 months after vaccination |
| Presence of adverse events of special interest (AESIs) | Number of participants experiencing AESIs regardless of causality | Within 6 months after vaccination |
| Presence of related SAEs throughout the study | Number of participants experiencing related SAEs regardless of causality | Throughout the study, approximately 12 months |
| Presence of related AESIs throughout the study | Number of participants experiencing related AESIs regardless of causality | Throughout the study, approximately 12 months |
| Presence of related fatal SAEs throughout the study | Number of participants experiencing related fatal SAEs regardless of causality | Throughout the study, approximately 12 months |
| Presence of out-of-range biological test results (including shift from baseline values) | Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values) | Within 7 days after vaccination |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines | Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination | At Day 01 and Day 29 |
| RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines | Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination | At Day 01 and Day 29 |
| hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines | Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination | At Day 01 and Day 29 |
| PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines | Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination | At Day 01 and Day 29 |
Frequently Asked Questions
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