RhinovirusEarly Phase 1NCT07399132
A Study of APL-10456-Vaccine
A Early Phase 1 study testing APL-10456-Vaccine in people with Rhinovirus, run by Apollo Therapeutics Ltd at 2 sites in Australia.
Trial summary
AP09CP01 is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study which is conducted in Australia. The main purpose of this research study is to evaluate the safety, side effects, and immune response of APL-10456-Vaccine, a Rhinovirus (RV) Vaccine, when compared with a placebo in Younger and Older… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinovirus
- What is being tested?
- APL-10456-Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesAustralia
- Study dates
- 16 Feb 2026to 18 May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age Part A: Age ≥18 years and ≤54 years Part B: Age ≥55 years
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Who cannot join
- History of severe allergic or anaphylactic reactions of any type
- Acutely ill or febrile (temperature ≥38.0°C/100.4°F) 72 hours prior to or at the Day 1 visit
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease/disorder within the past 3 months, or any acute minor illness (e.g. common cold, influenza, minor infection) within the past 1 month, determined by the PI (or delegate) to be clinically relevant
- Reported history of congenital or acquired immunodeficiency
- Dermatologic conditions that could affect local solicited AR assessments
- Coagulopathy or a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
Show all 15Show fewer
- Diagnosis of a malignancy within previous 5 years
- Has received systemic immunosuppressants for >14 days in total within 180 days prior to the Randomization Visit
- Has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the final study injection
- Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (eg, infliximab), or blood products within 90 days prior to the Randomization Visit or plans to receive them during the study
- Female participant with positive pregnancy test or Lactating females
- Has positive serology tests result (HIV, HCV and HBsAg) at screening visit
- Has positive drugs of abuse test results at screening visit
- Has participated in an interventional clinical study within 3 months prior to the Randomization Visit or plans to do so while participating in this study
- Has donated ≥450 mL of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Emeritus Research
Melbourne, Victoria, 3124
Veritus Research
Melbourne, Victoria, 3153
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, and Immunogenicity of APL-10456-Vaccine in Healthy Volunteers
AP09CP01 is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study which is conducted in Australia. The main purpose of this research study is to evaluate the safety, side effects, and immune response of APL-10456-Vaccine, a Rhinovirus (RV) Vaccine, when compared with a placebo in Younger and Older Healthy Volunteers
- Conditions
- Rhinovirus
- Being tested
- APL-10456-Vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL-10456-VaccineDrug
3 cohorts are planned for Part A and Part B
PlaceboOther
Placebo (a saline) is comparator to study vaccine
| Study group | Role | What they receive |
|---|---|---|
| Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year | Experimental | Part A: Three (3) APL-10456-Vaccine dose levels which will be a sequential cohort single dose-escalation are planned, Part B will be a parallel group randomized controlled study to evaluate a two dose, prime and boost regimen of APL-10456-Vaccine in 3 dose levels Receives: Drug: APL-10456-Vaccine |
| Placebo | Placebo comparator | Placebo is a comparator to Study Vaccine Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs)
Collecting AEs in Part A: HVs from 18 to 54 years of age, inclusive and Part B: HVs ≥ 55 years of age. Incidence, severity, relationship and outcome of Adverse Events (AE)
Measured: Through Study Completion (Approx 365 days)
Secondary outcomes (1)
To assess the immunogenicity of a single dose of APL-10456-Vaccine in Part A and B, and a prime/boost administration of APL-10456-Vaccine in Part B
serotype-specific anti-APL-10456 antibody (IgG) titers and seroconversion rates in serum samples
Measured: Day 8 and Day 29 in Part A and approximately monthly visits up to Day 365 in Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start16 Feb 2026
- Primary completion18 May 2027 (estimated)
- Study completion18 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollo Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399132
- Sponsor's protocol ID
- AP09CP01
- Status last verified
- May 2026
- First submitted
- 27 Jan 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, and Immunogenicity of APL-10456-Vaccine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07399132
- Acronym / sponsor ID
- AP09CP01
- Conditions
- Rhinovirus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Apollo Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 18 May 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AP09CP01 is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study which is conducted in Australia. The main purpose of this research study is to evaluate the safety, side effects, and immune response of APL-10456-Vaccine, a Rhinovirus (RV) Vaccine, when compared with a placebo in Younger and Older Healthy Volunteers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year | Experimental | Drug: APL-10456-VaccinePart A: Three (3) APL-10456-Vaccine dose levels which will be a sequential cohort single dose-escalation are planned, Part B will be a parallel group randomized controlled study to evaluate a two dose, prime and boost regimen of APL-10456-Vaccine in 3 dose levels |
| Placebo | Placebo comparator | Other: PlaceboPlacebo is a comparator to Study Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age Part A: Age ≥18 years and ≤54 years Part B: Age ≥55 years
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Key exclusion criteria (15 listed)
- History of severe allergic or anaphylactic reactions of any type
- Acutely ill or febrile (temperature ≥38.0°C/100.4°F) 72 hours prior to or at the Day 1 visit
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease/disorder within the past 3 months, or any acute minor illness (e.g. common cold, influenza, minor infection) within the past 1 month, determined by the PI (or delegate) to be clinically relevant
- Reported history of congenital or acquired immunodeficiency
- Dermatologic conditions that could affect local solicited AR assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APL-10456-Vaccine3 cohorts are planned for Part A and Part B | Drug | Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year |
| PlaceboPlacebo (a saline) is comparator to study vaccine | Other | Placebo |
Primary outcome
To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs)
Time frame: Through Study Completion (Approx 365 days)
Collecting AEs in Part A: HVs from 18 to 54 years of age, inclusive and Part B: HVs ≥ 55 years of age. Incidence, severity, relationship and outcome of Adverse Events (AE)
1 secondary outcome
To assess the immunogenicity of a single dose of APL-10456-Vaccine in Part A and B, and a prime/boost administration of APL-10456-Vaccine in Part B
Time frame: Day 8 and Day 29 in Part A and approximately monthly visits up to Day 365 in Part B
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing APL-10456-Vaccine in people with Rhinovirus, run by Apollo Therapeutics Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs) (time frame: Through Study Completion (Approx 365 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.