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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06573281




Registration number
NCT06573281
Ethics application status
Date submitted
26/08/2024
Date registered
27/08/2024

Titles & IDs
Public title
A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years
Scientific title
A Phase 1, First-Time-in-Human (FTiH), Observer-blind, Randomized, Controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of Various Doses of an mRNA-based Respiratory Syncytial Virus (RSV) Investigational Vaccine in Healthy Participants 18-45 Years of Age
Secondary ID [1] 0 0
2024-512846-41
Secondary ID [2] 0 0
222261
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Investigational RSV vaccine 1
Treatment: Other - Investigational RSV vaccine 2
Treatment: Other - Investigational RSV vaccine 3
Treatment: Other - Investigational RSV vaccine 4
Treatment: Other - Investigational RSV vaccine 5
Treatment: Other - Investigational RSV vaccine 6
Treatment: Drugs - Placebo

Experimental: RSV_Group A -

Experimental: RSV_Group B -

Experimental: RSV_Group C -

Experimental: RSV_Group D -

Experimental: RSV_Group E -

Experimental: RSV_Group F -

Placebo comparator: Placebo Group -


Treatment: Other: Investigational RSV vaccine 1
Investigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30.

Treatment: Other: Investigational RSV vaccine 2
Investigational RSV vaccine 2 administered intramuscularly on Day 1 and Day 30.

Treatment: Other: Investigational RSV vaccine 3
Investigational RSV vaccine 3 administered intramuscularly on Day 1 and Day 30.

Treatment: Other: Investigational RSV vaccine 4
Investigational RSV vaccine 4 administered intramuscularly on Day 1 and Day 30.

Treatment: Other: Investigational RSV vaccine 5
Investigational RSV vaccine 5 administered intramuscularly on Day 1 and Day 30.

Treatment: Other: Investigational RSV vaccine 6
Investigational RSV vaccine 6 administered intramuscularly on Day 1.

Treatment: Drugs: Placebo
Placebo administered intramuscularly on Day 1 and Day 30 and for RSV_Group F placebo administered only on Day 30.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants reporting solicited administration site events within 7 days post-dose 1
Timepoint [1] 0 0
From Day 1 to Day 7
Primary outcome [2] 0 0
Number of participants reporting solicited administration site events within 7 days post-Dose 2
Timepoint [2] 0 0
From Day 30 to Day 36
Primary outcome [3] 0 0
Number of participants reporting solicited systemic events within 7 days post-Dose 1
Timepoint [3] 0 0
From Day 1 to Day 7
Primary outcome [4] 0 0
Number of participants reporting solicited systemic events within 7 days post-Dose 2
Timepoint [4] 0 0
From Day 30 to Day 36
Primary outcome [5] 0 0
Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1
Timepoint [5] 0 0
From Day 1 to Day 29
Primary outcome [6] 0 0
Number of participants reporting unsolicited AEs within 29 days post-Dose 2
Timepoint [6] 0 0
From Day 30 to Day 58
Primary outcome [7] 0 0
Number of participants reporting serious adverse events (SAEs)
Timepoint [7] 0 0
From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Primary outcome [8] 0 0
Number of participants reporting medically attended adverse events (MAAEs)
Timepoint [8] 0 0
From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Primary outcome [9] 0 0
Number of participants reporting adverse event of special interest (AESI)
Timepoint [9] 0 0
From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Primary outcome [10] 0 0
Number of participants reporting fatal SAEs
Timepoint [10] 0 0
From Day 1 (Dose 1) up to Month 19 (study end)
Primary outcome [11] 0 0
Number of participants reporting related SAEs
Timepoint [11] 0 0
From Day 1 (Dose 1) up to Month 19 (study end)
Primary outcome [12] 0 0
Number of participants reporting related AESIs
Timepoint [12] 0 0
From Day 1 (Dose 1) up to Month 19 (study end)
Primary outcome [13] 0 0
Number of participants with clinically significant hematological and biochemical abnormalities at pre-study intervention administration
Timepoint [13] 0 0
At Day 1 (pre-Dose 1)
Primary outcome [14] 0 0
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
Timepoint [14] 0 0
At Day 8
Primary outcome [15] 0 0
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
Timepoint [15] 0 0
At Day 30
Primary outcome [16] 0 0
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2
Timepoint [16] 0 0
At Day 37
Secondary outcome [1] 0 0
RSV- A neutralizing titers expressed as Geometric mean titers (GMTs)
Timepoint [1] 0 0
At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2)
Secondary outcome [2] 0 0
RSV- B neutralizing titers expressed as GMTs
Timepoint [2] 0 0
At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2)
Secondary outcome [3] 0 0
Geometric mean fold increase in serum neutralizing titers against RSV-A from baseline
Timepoint [3] 0 0
Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)
Secondary outcome [4] 0 0
Geometric mean fold increase in serum neutralizing titers against RSV-B from baseline
Timepoint [4] 0 0
Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)
Secondary outcome [5] 0 0
Number of participants with seroresponse in terms of neutralizing titer against RSV-A
Timepoint [5] 0 0
Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)
Secondary outcome [6] 0 0
Number of participants with seroresponse in terms of neutralizing titer against RSV-B
Timepoint [6] 0 0
Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)

Eligibility
Key inclusion criteria
* Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).
* Written informed consent obtained from the participant prior to performance of any study-specific procedure.
* Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.
* Male or female between and including 18 and 45 years of age at the time of enrollment into the study.
* Body mass index more than or equal to (>=) 18 kg/m^2 or less than (<) 40 kg/m^2.
* 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 for 1 month prior to study intervention administration period, and
* has a negative pregnancy test (on urine sample) on the day of study intervention administration, and
* has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical conditions

* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
* Hypersensitivity to latex.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
* Recurrent history or uncontrolled neurological disorders or seizures.
* Documented HIV, HBV, or HCV-positive participant.
* Lymphoproliferative disorder or malignancy within 5 years before the first dose of study intervention administration.
* History of or current suspicion of myocarditis or pericarditis.

Prior/Concomitant therapy

* Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before the first dose of study intervention administration (Day -29 to Day 1), or their planned use during the study period.
* Has previously received an investigational or approved vaccine or antibody for prevention of RSV infection.
* Planned administration/administration of a vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention administration, except for inactivated vaccines for influenza if they are received at least 14 days before the first dose or 14 days after the last study intervention administration.
* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.

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 intervention (drug/invasive medical device).

Other exclusion criteria

* Pregnant or lactating female participant.
* Female participant planning to become pregnant or planning to discontinue contraceptive precautions within 1 month following the last study intervention administration.
* Alcoholism or substance use disorder within the past 24 months.
* Any study personnel or their immediate dependents, family, or household members.
* Participants with extensive body markings or conditions in the deltoid region that may preclude accurate assessment of local reactogenicity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/07/2026
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Camberwell
Recruitment postcode(s) [1] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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 terminated asset(s) across all indications.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06573281