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

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

Overview

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.

Interventions

• 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

Primary outcome measures

• 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]

Secondary outcome measures (3)

• 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.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Australia · 2 centers

• Emeritus Research Sydney — Botany
• Emeritus Research Camberwell — Camberwell

Identifiers

NCT: NCT07492706 · MKKCT-900-004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗