NCT07492706

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: MAXVAX Biotechnology Limited Liability Company · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	MKK900 60 µg	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
BIOLOGICAL	MKK900 120 µg	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
BIOLOGICAL	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

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-04-30
• Completion: 2027-01-15
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

2 sites across 1 country: Australia