A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

Respiratory Syncytial Virus Infections Clinical Trial

— RSV-OA=ADJ-020  

Official title:

A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05966090
• Other study ID #: 219331
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 28, 2023
• Est. completion date: July 16, 2024

Study information

• Verified date: November 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years of age.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 530
• Est. completion date: July 16, 2024
• Est. primary completion date: February 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• A male or female participant =50 YOA at the time of the first study intervention administration.

• Female participants of non-childbearing potential may be enrolled in the study.

• Female participants of childbearing potential may be enrolled in the study, if the participant:

• has practiced adequate contraception from 1 month prior to study intervention administration.

• has a negative pregnancy test on the day of and prior to study intervention administration.

• has agreed to continue effective contraception until the end of the study.

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed informed consent obtained from the participant prior to any study specific procedure being performed.

• Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.

• Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion Criteria:

Pregnant or lactating female.

• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to any vaccine component.

• History of Guillain-Barré syndrome.

• Any history of dementia or any medical condition that moderately or severely impairs cognition.

• Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.

• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.

• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

• Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of herpes zoster.

• History of previous vaccination with any licensed or investigational recombinant adjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start or planned receipt through study participation.

• History of previous vaccination with any licensed or investigational live herpes zoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.

• Previous vaccination with licensed or investigational RSV vaccine.

• Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, or their planned use during the study period.

• Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.

o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided COVID-19 vaccine use is in line with local governmental recommendations.

• Planned or actual administration of adjuvanted quadrivalent influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.

• Administration of long-acting immune-modifying drugs during the period starting 180 days before the administration of first dose of study interventions or planned administration at any time during the study period (e.g., infliximab).

• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions or planned administration during the study period.

• Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune modifying drugs during the period starting 90 days prior to the first study intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone =20 mg/day, or equivalent. Inhaled, topical or intra-articular steroids are allowed.

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product (IMP) (drug or invasive medical device).

• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.

• Bedridden participants.

• Planned move during the study conduct that prohibits participation until study end.

• Participation of any study personnel or their immediate dependents, family, or household members.

Related Conditions & MeSH terms

• Herpes Zoster
• Respiratory Syncytial Virus Infections
• Respiratory Syncytial Viruses

Intervention

Biological:
• RSVPreF3 OA investigational vaccine
One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
• HZ/su vaccine
Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Guelph	Ontario
Canada	GSK Investigational Site	Levis	Quebec
Canada	GSK Investigational Site	Mirabel	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Sarnia	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Corte Madera	California
United States	GSK Investigational Site	Daphne	Alabama
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	North Miami Beach	Florida
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Tempe	Arizona
United States	GSK Investigational Site	Versailles	Kentucky
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-gE antibody concentrations expressed as group geometric mean concentration (GMC) ratio		1-month after the second dose of HZ/su vaccine (at day 91)
Primary	Concentration of RSV-A neutralizing titers expressed as group geometric mean titer (GMT) ratio		1-month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-administration group and at Day 61 for the Control group)
Primary	Concentration of RSV-B neutralizing titers expressed as group GMT ratio		1-month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-administration group and at Day 61 for the Control group)
Secondary	Anti-gE antibody concentrations expressed as seropositivity rate		At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)
Secondary	Anti-gE antibody concentrations expressed as GMC		At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)
Secondary	Anti-gE antibody concentrations expressed as mean geometric increase (MGI)		At 1-month after the second dose of HZ/su vaccine (at Day 91) versus pre-vaccination (Day 1)
Secondary	Vaccine response rate at 1-month postsecond dose of HZ/su vaccine		At 1-month after the second dose of HZ/su vaccine (at Day 91)
Secondary	Concentration of RSV-A neutralizing titers expressed as GMT		At pre-vaccination and at 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 1 and Day 31 for the Co-administration group and at Day 31 and Day 61 for the Control group)
Secondary	Concentration of RSV-A neutralizing titers expressed as MGI		At 1-month after the RSVPreF3 OA investigational vaccine administration versus pre-vaccination (at Day 31 versus Day 1 for the Co-administration group and at Day 61 versus Day 31 for the Control group)
Secondary	Concentration of RSV-B neutralizing titers expressed as GMT		At pre-vaccination and at 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 1 and Day 31 for the Co-administration group and at Day 31 and Day 61 for the Control group)
Secondary	Concentration of RSV-B neutralizing titers expressed as MGI		At 1-month after the RSVPreF3 OA investigational vaccine administration versus pre-vaccination (at Day 31 versus Day 1 for the Co-administration group and at Day 61 versus Day 31 for the Control group)
Secondary	Percentage of participants reporting solicited administration site events (AE)	The solicited administration site AEs are erythema, pain and swelling.	During the 7 days after each vaccine administration (i.e., the day of vaccination and 6 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
Secondary	Percentage of participants reporting solicited systemic events	The solicited systemic events are arthralgia, fatigue, fever, headache, myalgia, shivering/chills and gastrointestinal symptoms.	During the 7 days after each vaccine administration (i.e., the day of vaccination and 6 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
Secondary	Percentage of participants reporting unsolicited Adverse Events (AEs)		During the 30 days after each vaccine administration (i.e., the day of vaccination and 29 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
Secondary	Percentage of participants reporting serious adverse events (SAEs)		From Day 1 up to study end (6 months after last vaccination administered at Day 61)
Secondary	Percentage of participants reporting potential immune mediated disorders (pIMDs)		From Day 1 up to study end (6 months after last vaccination administered at Day 61)