Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study

NCT ID: NCT04657198

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2021-10-25

Brief Summary

Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group High Dose_Adjuvanted

Participants in one of the high dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group High Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by intramuscular (IM) injection in the non-dominant arm.

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine (GSK3844766A)

Intervention Type: BIOLOGICAL

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).

Group Medium Dose_Adjuvanted

Participants in one of the medium dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Medium Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm.

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine (GSK3844766A)

Intervention Type: BIOLOGICAL

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).

Group Low Dose_Adjuvanted

Participants in one of the low dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Low Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm.

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine (GSK3844766A)

Intervention Type: BIOLOGICAL

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).

Interventions

RSVPreF3 OA investigational vaccine (GSK3844766A)

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female participants, who received 2 doses of RSVPreF3 OA investigational vaccine and formulations with matched adjuvant in part B of the parent study RSV OA=ADJ-002: recombinant RSVPreF3 antigen doses of low, medium and high strengths with adjuvant.
• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit, be available for contact)
• Written informed consent obtained from the participant prior to performance of any study specific procedure.

Exclusion Criteria

Medical conditions

• Significant underlying illness or administered therapy that in the opinion of the investigator would be expected to prevent participation in the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on information on concomitant medication/vaccination collected prior to the study start and physical examination.
• Serious or unstable chronic illness that developed during or after the parent study. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as clinically stable.
• Recurrent or un-controlled neurological disorders or seizures that developed during or after the parent study. Participants with medically-controlled active or 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 developed during or after the parent study, that in the opinion of the investigator would be expected to prevent completion of the study.
• Lymphoproliferative disorder and malignancy developed during or after the parent study.
• Any medical condition that developed during or after the parent study, that in the judgment of the investigator would make intramuscular injection unsafe.
• Previous vaccination with RSV vaccine, other than the one in the parent study.

Prior/Concomitant therapy

• Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the dose of study vaccine, or 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 and ending 30 days after the dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after the study vaccination.
• Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the dose of study vaccine 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 vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Confirmed use or anticipated use of immunosuppressive/cytotoxic therapy.

Prior/Concurrent clinical study experience

• 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.

Other exclusions

• Bedridden participants.
• Planned move to a location that will prohibit participating in the trial.
• History of chronic alcohol consumption and/or drug abuse that developed during or after the parent study as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Elkridge, Maryland, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Hickory, North Carolina, United States

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Wilrijk, , Belgium

Countries

United States; Belgium

References

Leroux-Roels I, Van Ranst M, Vandermeulen C, Abeele CV, De Schrevel N, Salaun B, Verheust C, David MP, Kotb S, Hulstrom V. Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. J Infect Dis. 2024 Feb 14;229(2):355-366. doi: 10.1093/infdis/jiad321.

Reference Type: DERIVED

PMID: 37699064 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-000692-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

213569

Identifier Type: -

Identifier Source: org_study_id