Clinical trial NCT06473519: A Study to Assess Safety, Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults.
Official title: A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE FORMULATED IN MULTIDOSE VIALS IN HEALTHY FEMALE ADULTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: RSV infection
Multidose Vial (MDV)
Single-dose Vial (SDV)
2-Phenoxyethanol (2-PE)
Vaccines
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-06-25
Enrollment: 453
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness, where medical help is needed. RSV can lead to airway diseases in all ages. Vaccines help your body make antibodies. These antibodies help fight against diseases. This is called an immune response.

The purpose of this study is to learn about the safety, tolerability, and immunogenicity of a RSV vaccine called RSVpreF. RSVpreF comes either as:

* a single dose in a container (called a vial),
* or in a vial that holds multiple doses. A multidose vial contains more than one dose of RSVpreF.

  2-Phenoxyethanol (2-PE) is a preservative to help prevent the growth of bacteria (germs). This study will compare RSVpreF with an added preservative called 2-phenoxyethanol (2-PE) from a multidose vial, to RSVpreF without an added preservative, from a single-dose vial.

This study is looking to enroll nonpregnant, nonbreastfeeding, healthy female participants.

Participants will need to visit the study clinic two times during the study. Participants will also have a final safety telephone call at the end of the study. All participants will receive a single shot of the study vaccine either from:

* a multidose vial (with the preservative), or
* from a single-dose vial (without the preservative) at the first study clinic visit.

Blood samples will be taken at the two study clinic visits. Each participant will take part in the study for around 6 weeks.


Eligibility criteria: Inclusion Criteria:

1. Healthy nonpregnant, nonbreastfeeding females 18 through 49 years of age at Visit 1 (Day 1).
2. Willing and able to comply with all scheduled visits, investigational plan, lifestyle considerations, and other study procedures.
3. Available for the duration of the study and can be contacted by telephone during study participation.
4. Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.

Exclusion Criteria:

1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the vaccines being administered in the study.
3. Immunocompromised participants with known or suspected immunodeficiency, as determined by history, laboratory tests, and/or physical examination.
4. History or active autoimmune disease, including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
5. Bleeding diathesis or any condition that would, in the opinion of the investigator, contraindicate intramuscular injection.
6. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt of a nonstudy RSV vaccine throughout the study.
7. Receipt of chronic systemic treatment with immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study.
8. Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration or planned receipt throughout the study.
9. Current alcohol abuse or illicit drug use.
10. Individuals who are pregnant or breastfeeding.
11. Participation in other studies involving an investigational product within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Primary outcomes:
measure: Primary Immunogenicity - Geometric mean titer (GMT) ratio estimated by the ratio of the GMTs for RSV A and RSV B serum neutralizing titers (NTs) with RSVpreF in MDV participants to that in the RSVpreF SDV participants
timeFrame: Before vaccination, and 1 month after vaccination
measure: The proportion of participants reporting local reactions
timeFrame: Baseline through Day 7
measure: The proportion of participants reporting systemic events
timeFrame: Baseline through Day 7
measure: The proportion of participants reporting adverse events
timeFrame: Through 1 month after vaccination
measure: The proportion of participants reporting serious adverse events
timeFrame: Throughout the study duration, up to 7 weeks.
Secondary outcomes:
measure: Seroresponse rates by vaccine group
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Rexburg
country: United States
facility: Clinical Research Prime Rexburg
state: Idaho
city: Southfield
country: United States
facility: Headlands Research - Detroit
state: Michigan
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC dba Flourish Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: