An extension and crossover vaccination study on the immune response and safety of a vaccine against respiratory syncytial virus given to adults 60 years of age and above who participated in RSV OA=ADJ-006 study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]

Trial duration

1 Aug 2024 → ongoing

Decision date (initial)

2024-06-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Others, Safety

"- RSV_PreS4 group: to evaluate the humoral immune response following a single revaccination dose of RSVPreF3 OA vaccine given at pre-Season 4
- RSV_PreS5 group: to evaluate the humoral immune response following a single revaccination dose of RSVPreF3 OA vaccine given at pre-Season 5"

Secondary objectives 1

1. "- RSV_1dose group: to evaluate the humoral immune persistence induced by the initial dose of the RSVPreF3 OA vaccine given at the start of the RSV OA=ADJ-006 study - All participants: to evaluate the safety of each vaccination schedule "

Conditions and MedDRA coding

Respiratory Syncytial Virus Infections

Study design 1 period

Regulatory references

Plan to share IPD

Yes

IPD plan description

GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gskstudyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf. IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months. IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. '- Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group).
2. "- 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, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications). Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant’s health status while answering diaries or make decisions on behalf of the participant. Refer to Section 8 and Definition of Terms of the Clinical Study Protocol for the definition of caregiver. "
3. "- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. "
4. '- Participants who are medically stable in the opinion of the investigator at study entry. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.

Exclusion criteria 13

1. '- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
2. '- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (For details on components of study intervention administered, refer to Arexvy SmPC/Prescribing information) [Arexvy Summary of Product Characteristics, 2023; Arexvy Prescribing Information, 2023].
3. '- Hypersensitivity to latex.
4. '- Serious or unstable chronic illness.
5. '- Recurrent or un-controlled neurological disorders or seizures. 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 (e.g., completion of diary cards, attend regular phone calls/study site visits).
6. '- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
7. '- Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
8. '- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
9. "- Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures. Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant. "
10. '- Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.
11. '- Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.
12. '- 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 first study visit, or their planned use during the study period.
13. '- Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. RSV_PreS4 group: - RSV-A and RSV-B neutralizing titers before revaccination (pre-Season 4, Day 1) and 30 days post-revaccination (Day 31) - Fold increase in RSV-A and RSV-B neutralizing titers from Day 1 to Day 31 - RSV-A and RSV-B neutralizing titers ≥cut-off at Day 1 and Day 31 - Participant having a ≥4-fold increase in neutralizing titers (Day 31 over Day 1)
2. "RSV_PreS5 group: - RSV-A and RSV-B neutralizing titers before revaccination (pre-Season 4 and pre-Season 5), 30 days post-revaccination and at pre-Season 6 - Fold increase in RSV-A and RSV-B neutralizing titers from pre-Season 5 to Day 31 and pre-Season 6 - RSV-A and RSV-B neutralizing titers ≥cut-off at pre-Season 4, pre-Season 5, Day 31 and pre-Season 6 - Participant having a ≥4-fold increase in neutralizing titers (Day 31 over pre-Season 5)"

Secondary endpoints 2

1. "RSV_1dose group: - RSV-A and RSV-B Neutralizing titers at pre-Season 4, pre-Season 5 and pre-Season 6 - RSV-A and RSV-B Neutralizing titers ≥cut-off at pre-Season 4, pre-Season 5 and pre-Season 6 "
2. "All participants: - Occurrence of unsolicited AEs with an onset during the 30-day follow-up period after vaccination (i.e., the day of vaccination and 29 subsequent days) - Occurrence of all SAEs/pIMDs from the day of vaccination up to 6 months after vaccination - Occurrence of SAEs/pIMDs related to study vaccination from Day 1 up to study end - Occurrence of fatal SAEs from Day 1 up to study end"

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'Institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 10

Locations

7 EU/EEA countries · 90 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 126 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

21 submissions — initial application plus substantial / non-substantial modifications