Respiratory Syncytial Virus Infections+Metapneumovirus
Conditions
Keywords
Safety, Reactogenicity, Immunogenicity, Respiratory syncytial virus (RSV), Human metapneumovirus (hMPV)
Brief summary
The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.
Interventions
BIOLOGICALRSV/hMPV_V low dose vaccine
RSV/hMPV\_V low dose vaccine administered intramuscularly.
BIOLOGICALRSV/hMPV_V medium dose vaccine
RSV/hMPV\_V medium dose vaccine administered intramuscularly.
BIOLOGICALRSV/hMPV_V high dose vaccine
RSV/hMPV\_V high dose vaccine administered intramuscularly.
BIOLOGICALRSV/hMPV_W low dose vaccine
RSV/hMPV\_W low dose vaccine administered intramuscularly.
BIOLOGICALRSV/hMPV_W medium dose vaccine
RSV/hMPV\_W medium dose vaccine administered intramuscularly.
BIOLOGICALRSV/hMPV_W high dose vaccine
RSV/hMPV\_W high dose vaccine administered intramuscularly.
BIOLOGICALRSV/hMPV_X low dose vaccine
RSV/hMPV\_X low dose vaccine administered intramuscularly.
BIOLOGICALRSV/hMPV_X medium dose vaccine
RSV/hMPV\_X medium dose vaccine administered intramuscularly.
BIOLOGICALRSV/hMPV_X high dose vaccine
RSV/hMPV\_X high dose vaccine administered intramuscularly.
BIOLOGICALhMPV_Y low dose vaccine
hMPV\_Y low dose vaccine administered intramuscularly.
BIOLOGICALhMPV_Y medium dose vaccine
hMPV\_Y medium dose vaccine administered intramuscularly.
BIOLOGICALhMPV_Y high dose vaccine
hMPV\_Y high dose vaccine administered intramuscularly.
BIOLOGICALhMPV_Z low dose vaccine
hMPV\_Z low dose vaccine administered intramuscularly.
BIOLOGICALhMPV_Z medium dose vaccine
hMPV\_Z medium dose vaccine administered intramuscularly.
BIOLOGICALhMPV_Z high dose vaccine
hMPV\_Z high dose vaccine administered intramuscularly.
BIOLOGICALControl vaccine
Control vaccine administered intramuscularly.
COMBINATION_PRODUCTPlacebo
Placebo administered intramuscularly.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is an observer-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply: * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications). * Note: For OA participants, in case of physical incapacity that would preclude the self-completion of the eDiaries, either site staff can assist the participant (for activities performed during site visits) and/or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home). However, at no time will the site staff or caregiver evaluate the participant's health status while answering eDiaries or make decisions on behalf of the participant. * Body Mass Index (BMI) between 18 kg/m\^2 and 33 kg/m\^2, inclusive. Specific inclusion criteria for OA * A male or female between and including, 60 to 80 YOA at the time of the study intervention administration. * Healthy participants or medically stable patients as established by medical history, physical examination (and normal screening laboratory tests including Grade 1 laboratory abnormalities that are not-clinically significant in Phase 1 only). Specific inclusion criteria for YA * A male or female participant between and including 18 to 49 YOA at the time of the study intervention administration. * Healthy participants as established by medical history, clinical examination and laboratory assessment at screening. * Participants of non-childbearing potential may be enrolled in the clinical study. * Participant of childbearing potential may be enrolled in the study if the participant: * has used two methods of contraception, at-least one of which must be a highly effective method, and the other being male condom for male sexual partners of POCBP to be used during sexual intercourse (with the exception of sexual abstinence, vasectomized partner and male partner who has been sterilized, in which case contraception is not required), at-least 30 days prior to study intervention administration, and has agreed to continue using above contraception requirements for 8 weeks after study intervention administration. * has a negative serum pregnancy test at screening and negative urine pregnancy test prior to study intervention administration on Day 1.
Exclusion criteria
Participants are excluded from participating in the study if any of the following criteria apply: * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). * Any medical condition that in the judgment of the investigator would make IM injection unsafe. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) 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). * Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history. * Documented history of HIV, HBV, HCV infection. * History of RSV and /or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months. * Recurrent history or uncontrolled neurological disorders or seizures, or history of demyelinating conditions (including GBS). * Any history of dementia or any medical condition that moderately or severely impairs cognition. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease). * 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 study intervention administration (Day -29 to Day 1), or within 5 half-lives, whichever is longer, or their planned use during the study period. * Has previously received an investigational or approved vaccine or antibody for prevention of hMPV and/or RSV-associated diseases. * 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. * Up to 3 months prior to the study intervention administration: * For corticosteroids, this will mean prednisone equivalent \>=20 mg/day for adult participants. Inhaled, topical and intra-articular steroids are allowed. * Administration of immunoglobulins and/or any blood products or plasma derivatives. * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. * 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. * 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. * Participation of any study personnel or their immediate dependents, family, or household members. * Planned move during the study period that will prohibit participating in the study until study end. * Bedridden participants. Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Administration Site Events | Day 1 to Day 7 | Solicited administration site events include pain, redness (erythema) and swelling at administration site. |
| Number of Participants Reporting Solicited Systemic Events | Day 1 to Day 7 | Solicited systemic events include fever \[defined as oral or axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F\], headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | Day 1 to Day 30 | An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. |
| Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | Day 1 to Month 12 | MAAE is defined as unscheduled visit to or from healthcare professional for any reason, including emergency room visits. |
| Number of Participants Reporting Potential immune-mediated disorders (pIMDs) | Day 1 to Month 12 | pIMDs are a subset of AEs of Special Interest (AESIs) that include autoimmune disorders and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Day 1 to study end [Month 24 for OA groups (only the selected formulation group&its comparators), Month 12 for YA groups & OA groups (all other investigational vaccine formulation groups not selected for future clinical development&other comparators)] | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. |
| Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities | At Day 1 (pre-vaccination) in Phase 1 groups | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with hMPV neutralization titers equal to or above (>=) the assay cut-off value | At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups | — |
| Geometric mean titers (GMTs) of hMPV neutralization titers | At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups | — |
| Mean geometric increase (MGI) of hMPV neutralization titers | At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups | — |
| Seroresponse rate (SRR) against hMPV | At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups | SRR is defined as the number of participants having \>=4-fold increase post-vaccination in neutralization titers against hMPV. |
| Number of participants with RSV-A neutralization titers >= assay cut-off value | At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups | — |
| GMTs of RSV-A neutralization titers | At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups | — |
| MGI of RSV-A neutralization titers | At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups | — |
| SRR against RSV-A | At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups | SRR is defined as number of participants having \>=4-fold-increase post-vaccination in neutralization titers against RSV-A. |
| Number of participants with RSV-B neutralization titers >= assay cut-off value | At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups | — |
| GMTs of RSV-B neutralization titers | At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups | — |
| MGI of RSV-B neutralization titers | At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups | — |
| SRR against RSV-B | At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups | SRR is defined as number of participants having \>=4-fold-increase post-vaccination in neutralization titers against RSV-B. |
| Cell-mediated immunity (CMI) response expressed as frequency of hMPV-specific CD4+ T-cells | At Day 1 (pre-vaccination) and Day 31 in Phase 2 OA groups | — |
| CMI response expressed as frequency of hMPV-specific CD8+ T-cells | At Day 1 (pre-vaccination) and Day 31 in Phase 2 OA groups | — |
| Geometric mean fold-increase of the hMPV-specific CD4+ T-cells frequency | At Day 31 compared to Day 1 (pre-vaccination) in Phase 2 OA groups | — |
| Geometric mean fold-increase of the hMPV-specific CD8+ T-cells frequency | At Day 31 compared to Day 1 (pre-vaccination) in Phase 2 OA groups | — |
Countries
Australia, United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed