Respiratory Syncytial Virus (RSV)Phase 1RSVVaccineNCT07492706
Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women
A Phase 1 study testing MKK900 60 µg, MKK900 120 µg and ABRYSVO® in people with Respiratory Syncytial Virus (RSV), run by MAXVAX Biotechnology Limited Liability Company at 2 sites in Australia.
Trial summary
A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- MKK900 60 µg, MKK900 120 µg and ABRYSVO®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Apr 2026to 15 Jan 2027
- Phase
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult females 18-49 years old on the day of vaccination.
- Generally healthy, as established by medical history and clinical examination before vaccination and absence of unresolved acute disease or acute exacerbation of chronic disease.
- Intent to reside in the area of the study site for the throughout the study visits and also available for phone follow ups after vaccination.
- Signing an Informed Consent Form indicating that the purpose, procedures and potential risks and benefits of the study have been explained including an opportunity to ask questions.
- Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use acceptable, highly effective methods of contraception from 28 days prior to vaccination on Day -1 through to 90 days after vaccination. Females must also agree not to donate ova from the first dose of the study vaccine until at least 90 days after vaccination.
Who cannot join
- Recent RSV exposure/vaccination: History of RSV infection within 6 months or prior RSV vaccination.
- Pregnancy/lactation: Pregnant, breastfeeding, or planning pregnancy within 90 days post-vaccination.
- Recent investigational products: Received any investigational product within 30 days or plans study participation during this trial.
- Recent vaccines: Live vaccine within 30 days or any other vaccine within 14 days before study vaccination, or planned vaccination within 3 months after.
- Blood products: Received immunoglobulins or blood products within 6 months.
- Recent blood donation: Donation/loss of >450 mL of blood or components within 14 days of Day 1.
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- Active illness: Acute illness or acute flare of chronic disease within 3 days before vaccination.
- Vaccine allergies: Allergy to vaccine components (especially aminoglycosides) or severe reactions to past vaccines.
- Neurological conditions: History of seizures, epilepsy, encephalopathy, or significant neurological disorders.
- Mental health concerns: Any mental illness that may affect study compliance or AE reporting.
- Malignancy: Active cancer or cancer within past 5 years (except adequately treated skin or cervical lesions).
- Splenic issues: Asplenia, functional asplenia, or splenectomy.
- Immunodeficiency/autoimmune disease: Congenital/acquired immunodeficiency or autoimmune diseases per Investigator judgement.
- Immunosuppressive therapy: Systemic immunosuppressants (e.g., prolonged steroids) within 3 months; inhaled/topical steroids allowed.
- Severe chronic diseases: Severe cardiac, pulmonary, hepatic, renal disease, or diabetes.
- Coagulation issues: History of thrombocytopenia or bleeding disorders contraindicating IM injection.
- Fever/infection: Fever >38°C or active systemic infection within 7 days of vaccination.
- Hypertension: Abnormal or uncontrolled high blood pressure at screening (≥140/90 mmHg).
- Known or suspected infection with HBV, HCV, or HIV.
- Alcohol or drug abuse, including regular alcohol intake of >14 drinks/week or >4 drinks/day.
- Positive drug screen (amphetamines, barbiturates, benzodiazepines, cocaine, THC, methadone, methamphetamine, opiates, PCP, tricyclic antidepressants) or positive alcohol breath test at Screening or Day -1.
- Inability to assess injection site due to tattoos or skin conditions on both deltoids.
- Study site employees involved in the protocol or with access to study data.
- Any other condition that may impact participant safety or interfere with study assessments, as judged by the Investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
Emeritus Research Sydney
Botany, New South Wales, 2019
Dr Ronald Lok Yeung Mak, +610289648186, ronaldmak@emeritusresearch.com
Dr Ronald Lok Yeung Mak
Emeritus Research Camberwell
Camberwell, Victoria, 3124
Dr Ri Peng (Justin) Tan, +610395096166, justintan@emeritusresearch.com
Dr Ri Peng (Justin) Tan
About this study
Official title: A Phase 1, Randomized, Blinded, Active Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant, Stabilized Pre-F Respiratory Syncytial Virus (RSV) Vaccine (MKK900), Non-adjuvanted, in Healthy Women Aged 18-49 Years
A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age
Read the detailed description
A Phase 1, randomized, blinded, active controlled clinical trial to evaluate the safety, tolerability and immunogenicity of a recombinant, stabilized pre-f respiratory syncytial virus (RSV) vaccine (MKK900), non-adjuvanted, in healthy women aged 18-49 years
Participants will be randomized in a 1:1:1 ratio to receive a single IM injection of one of low-dose MKK900, high-dose MKK900 or the active control (ABRYSVO).
Participants will be immunized on day 1 and safety and immunogenicity will be evaluated at day 8, 31 and 91. Safety will also be assessed at day 181.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- MKK900 60 µg, MKK900 120 µg, ABRYSVO®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MKK900 60 µgBiological
Unit Dose Strength: The 60-μg dose vial will have a concentration of 120 μg/mL (0.5 mL injection volume) Route of Administration : Intramuscular Injection
MKK900 120 µgBiological
Unit Dose Strength: The 120-μg dose vial will have a concentration of 240 μg/mL (0.5 mL injection volume).
Route of Administration : Intramuscular Injection
ABRYSVO®Biological
Dose Formulation: Vial of Lyophilized Antigen Component (sterile white power) that is reconstituted at the time of use with a Sterile Water Diluent Component.
Unit Dose Strength: 120 µg of RSV stabilized pre-fusion F proteins (60 µg RSV pre-F A and 60 µg RSV pre-F B) per 0.5 mL.
Route of Administration: Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| MKK900 60 µg | Experimental | stabilized pre-F antigen from Type A RSV Receives: Biological: MKK900 60 µg |
| MKK900 120 µg | Experimental | stabilized pre-F antigen from Type A RSV Receives: Biological: MKK900 120 µg |
| ABRYSVO | Active comparator | Not described Receives: Biological: ABRYSVO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of solicited local and systemic adverse events (AEs)
Measured: during the 7 days following vaccination
Frequency of unsolicited adverse events AEs
Measured: during the 30 days following vaccination
Frequency of serious adverse events (SAEs)
Measured: up to 180 days after vaccine administration
Secondary outcomes (3)
Geometric mean titers (GMTs) of neutralizing antibodies against RSV types A and B
Measured: Day 7, Day 30, and Day 90 post-vaccination.
Geometric mean fold rise (GMFR) of neutralizing antibodies against RSV types A and B
Measured: Day 7, Day 30, and Day 90 post-vaccination.
Seroresponse rate of neutralizing antibodies against RSV types A and B
Measured: Day 7, Day 30, and Day 90 post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MAXVAX Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492706
- Sponsor's protocol ID
- MKKCT-900-004
- Acronym
- RSVVaccine
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Active Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant, Stabilized Pre-F Respiratory Syncytial Virus (RSV) Vaccine (MKK900), Non-adjuvanted, in Healthy Women Aged 18-49 Years
- ClinicalTrials.gov ID
- NCT07492706
- Acronym / sponsor ID
- RSVVaccine / MKKCT-900-004
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- MAXVAX Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 25 Mar 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.
A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age
Detailed description
A Phase 1, randomized, blinded, active controlled clinical trial to evaluate the safety, tolerability and immunogenicity of a recombinant, stabilized pre-f respiratory syncytial virus (RSV) vaccine (MKK900), non-adjuvanted, in healthy women aged 18-49 years
Participants will be randomized in a 1:1:1 ratio to receive a single IM injection of one of low-dose MKK900, high-dose MKK900 or the active control (ABRYSVO).
Participants will be immunized on day 1 and safety and immunogenicity will be evaluated at day 8, 31 and 91. Safety will also be assessed at day 181.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MKK900 60 µg | Experimental | Biological: MKK900 60 µgstabilized pre-F antigen from Type A RSV |
| MKK900 120 µg | Experimental | Biological: MKK900 120 µgstabilized pre-F antigen from Type A RSV |
| ABRYSVO | Active comparator | Biological: ABRYSVO® |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult females 18-49 years old on the day of vaccination.
- Generally healthy, as established by medical history and clinical examination before vaccination and absence of unresolved acute disease or acute exacerbation of chronic disease.
- Intent to reside in the area of the study site for the throughout the study visits and also available for phone follow ups after vaccination.
- Signing an Informed Consent Form indicating that the purpose, procedures and potential risks and benefits of the study have been explained including an opportunity to ask questions.
- Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use acceptable, highly effective methods of contraception from 28 days prior to vaccination on Day -1 through to 90 days after vaccination. Females must also agree not to donate ova from the first dose of the study vaccine until at least 90 days after vaccination.
Key exclusion criteria (24 listed)
- Recent RSV exposure/vaccination: History of RSV infection within 6 months or prior RSV vaccination.
- Pregnancy/lactation: Pregnant, breastfeeding, or planning pregnancy within 90 days post-vaccination.
- Recent investigational products: Received any investigational product within 30 days or plans study participation during this trial.
- Recent vaccines: Live vaccine within 30 days or any other vaccine within 14 days before study vaccination, or planned vaccination within 3 months after.
- Blood products: Received immunoglobulins or blood products within 6 months.
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 |
|---|---|---|
| MKK900 60 µgUnit Dose Strength: The 60-μg dose vial will have a concentration of 120 μg/mL (0.5 mL injection volume) Route of Administration : Intramuscular Injection | Biological | MKK900 60 µg |
| MKK900 120 µgUnit Dose Strength: The 120-μg dose vial will have a concentration of 240 μg/mL (0.5 mL injection volume). Route of Administration : Intramuscular Injection | Biological | MKK900 120 µg |
| ABRYSVO®Dose Formulation: Vial of Lyophilized Antigen Component (sterile white power) that is reconstituted at the time of use with a Sterile Water Diluent Component. Unit Dose Strength: 120 µg of RSV stabilized pre-fusion F proteins (60 µg RSV pre-F A and 60 µg RSV pre-F B) per 0.5 mL. Route of Administration: Intramuscular injection | Biological | ABRYSVO |
Primary outcome
Frequency of solicited local and systemic adverse events (AEs)
Time frame: during the 7 days following vaccination
Frequency of unsolicited adverse events AEs
Time frame: during the 30 days following vaccination
Frequency of serious adverse events (SAEs)
Time frame: up to 180 days after vaccine administration
3 secondary outcomes
Geometric mean titers (GMTs) of neutralizing antibodies against RSV types A and B
Time frame: Day 7, Day 30, and Day 90 post-vaccination.
Geometric mean fold rise (GMFR) of neutralizing antibodies against RSV types A and B
Time frame: Day 7, Day 30, and Day 90 post-vaccination.
Seroresponse rate of neutralizing antibodies against RSV types A and B
Time frame: Day 7, Day 30, and Day 90 post-vaccination.
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 25 Mar 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MKK900 60 µg, MKK900 120 µg and ABRYSVO® in people with Respiratory Syncytial Virus (RSV), run by MAXVAX Biotechnology Limited Liability Company 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 5 inclusion and 24 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: opening soon, as of the sponsor's last update on 25 Mar 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. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Zhou (Jo) Jiang (+1515-598-6266, zhou.jiang@maxvax.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of solicited local and systemic adverse events (AEs) (time frame: during the 7 days following vaccination). The study lists 3 primary outcomes in all. 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 25 Mar 2026.