Clinical trial NCT06481579: A Study of IVX-A12 in Adults Participants
Official title: A Phase 2, Randomized, Modified Double-Blind, Active Controlled Study to Characterize the Safety and Immunogenicity of IVX-A12 in Adults 60 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Participants
Keywords: Respiratory syncytial virus (RSV)
Human metapneumovirus (hMPV)
Lead sponsor: Icosavax, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 143
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to assess the immunogenicity and safety of IVX-A12 in adults 60 years of age and older.

Detailed description: This is a randomized, modified double-blind, active controlled study to characterize the immunogenicity and safety of IVX-A12.

Approximately 140 participants will be randomized in a 1:1 ratio to receive IVX-A12 (approximately 70) or licensed respiratory syncytial virus (RSV) vaccine (approximately 70).

The study is planned to be conducted at approximately 5 sites in the United States. The duration of each participant's involvement in the study will be approximately 6 months following administration of study vaccination.

Eligibility criteria: Inclusion Criteria:

1. Adults \>=60 years of age at the time of signing informed consent.
2. Participants who are medically stable according to the judgment of the Investigator.
3. Able to understand and comply with study requirements/procedures based on the assessment of the Investigator.
4. Capable of giving signed informed consent.

Exclusion Criteria:

1. Acute (time-limited) or febrile (temperature \>=38.0 °C \[100.4 ºF\]) illness/infection within 3 days of planned dosing.
2. History of a clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
3. History of hypersensitivity to any component of the study vaccination.
4. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis).
5. Known or suspected congenital or acquired immunodeficiency.
6. Known or suspected autoimmune condition as determined by history and/or physical examination.
7. History of Guillain-Barré syndrome or any other demyelinating condition.
8. History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.
9. Any condition that may significantly increase the risk to the participant because of participation in the study, impact the participant's ability to participate in the study, or impair the interpretation of the study data.
10. Receipt of any licensed or investigational RSV and/or Human metapneumovirus (hMPV) vaccine any time prior to administration of study intervention.
11. Receipt of any licensed vaccine (other than licensed influenza or COVID-19 vaccines) within 28 days prior to or expected receipt within 28 days after administration of study intervention. Licensed influenza or COVID-19 vaccines are permitted beginning greater than (\>)14 days prior to and \>14 days after administration of study intervention.
12. Receipt of immunoglobulin or blood products within 3 months prior to administration of study intervention or expected receipt during the study.
13. Receipt of immune-modifying drugs or immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within 6 months prior to enrollment (or expected receipt during study), or long-term systemic corticosteroid therapy (prednisolone or equivalent at a dose of \>=20 mg daily or every other day for more than 2 consecutive weeks) within 6 months prior to study intervention or anticipated receipt during study.
14. Participation in another study or receiving interventional study investigational medicinal product (IMP), in the preceding 28 days or expected receipt of another study intervention (or participation in another study) during the period of study follow-up.
15. Employees of the Sponsor involved in planning, executing, supervising, or reviewing the IVX-A12 program, clinical study site staff, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
16. Alcohol or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
17. Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily.
18. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

Primary outcomes:
measure: Geometric Mean Titers (GMT) for RSV/A Neutralizing Antibodies (NAb)
timeFrame: Day 29
measure: Geometric Mean Fold Rise (GMFR) in RSV/A NAb Titers
timeFrame: From Day 0 (pre-vaccination) up to Day 29 post-vaccination
measure: Number of Participants With Immediate Unsolicited Adverse Events (AEs)
timeFrame: Day 1 within 30 minutes post-vaccination
measure: Number of Participants With Injection Site and Systemic Solicited Adverse reactions (ARs)
timeFrame: Day 1 through 7 post-vaccination
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Day 1 through 28 post-vaccination
measure: Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), and Adverse Events of Special Interests (AESIs)
timeFrame: Through 6 months post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Icosavax Investigational Site US022
state: California
city: Rolling Hills Estates
country: United States
facility: Icosavax Investigational Site US021
state: California
city: Hollywood
country: United States
facility: Icosavax Investigational Site US002
state: Florida
city: Lenexa
country: United States
facility: Icosavax Investigational Site US011
state: Kansas
city: North Charleston
country: United States
facility: Icosavax Investigational Site US016
state: South Carolina
Study officials:
References: