Not Yet RecruitingPhase 1

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

Australia120 participantsStarted 2026-04-01

Plain-language summary

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

Age range18 Years – 49 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Frequency of solicited local and systemic adverse events (AEs)

Timeframe: during the 7 days following vaccination

Frequency of unsolicited adverse events AEs

Timeframe: during the 30 days following vaccination

Frequency of serious adverse events (SAEs)

Timeframe: up to 180 days after vaccine administration

NCT IDNCT07492706

SponsorMAXVAX Biotechnology Limited Liability Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

Zhou (Jo) Jiang

Who can participate