Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women

NCT07492706 | Not Yet Recruiting Phase 1

• 1 other identifier: MKKCT-900-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (3)

• Frequency of solicited local and systemic adverse events (AEs)

  during the 7 days following vaccination

• Frequency of unsolicited adverse events AEs

  during the 30 days following vaccination

• Frequency of serious adverse events (SAEs)

  up to 180 days after vaccine administration

Secondary Outcomes (3)

• Geometric mean titers (GMTs) of neutralizing antibodies against RSV types A and B

  Day 7, Day 30, and Day 90 post-vaccination.

• Geometric mean fold rise (GMFR) of neutralizing antibodies against RSV types A and B

  Day 7, Day 30, and Day 90 post-vaccination.

• Seroresponse rate of neutralizing antibodies against RSV types A and B

  Day 7, Day 30, and Day 90 post-vaccination.

Study Arms (3)

MKK900 60 µg

EXPERIMENTAL

stabilized pre-F antigen from Type A RSV

Biological: MKK900 60 µg

MKK900 120 µg

EXPERIMENTAL

stabilized pre-F antigen from Type A RSV

Biological: MKK900 120 µg

ABRYSVO

ACTIVE COMPARATOR

Biological: ABRYSVO®

Interventions

MKK900 60 µg BIOLOGICAL

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 60 µg

MKK900 120 µg BIOLOGICAL

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

MKK900 120 µg

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

ABRYSVO

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: The study population of healthy women aged 18-49 is designed to provide safety and immunogenicity data that will support a subsequent clinical study in pregnant women, which is the target population for this vaccine
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MAXVAX Biotechnology Limited Liability Company: lead

Study Sites (2)

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

Location

Emeritus Research Camberwell

Camberwell, Victoria, 3124, Australia

Location

MeSH Terms

Interventions

abrysvo

Central Study Contacts

Zhou (Jo) Jiang

CONTACT

+1515-598-6266; zhou.jiang@maxvax.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

AU (2)