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NTHi Mcat investigational vaccine · 2 trials · 1 indication
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) injection site.
Assessed solicited general symptoms were chills, gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), fatigue, myalgia, headache and fever \[defined Oral cavity or axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject or was a congenital anomaly/birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.
Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.
| Arm | Type | Description |
|---|---|---|
| Schedule 0-2-6 Group | EXPERIMENTAL | Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12). |
| Schedule 0-2-12 Group | EXPERIMENTAL | Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6). |
| GSK3277511A Group | EXPERIMENTAL | Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2) at Day 1 and Day 61. |
| CONTROL Group | PLACEBO_COMPARATOR | Healthy males and females, 40 to 80 years of age, who received two doses of placebo vaccine at Day 1 and Day 61. |
| Name | Type | Description |
|---|---|---|
| NTHi Mcat investigational vaccine (GSK3277511A) | BIOLOGICAL | Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm and a third dose administered at either Day 181 or Day 361, according to each vaccination scheduling defined per protocol. |
| Placebo | BIOLOGICAL | One dose administered intramuscularly at either Day 181 or Day 361 in the deltoid region of the non-dominant arm. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * A male or female between, and including, 40 and 80 years of age...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Ralinepag |
| AstraZeneca PLC | AZN | 2 | - | Undisclosed |
| Intuitive Surgical, Inc. | ISRG | 1 | - | Undisclosed |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | - | Undisclosed |
The NTHi Mcat investigational vaccine is being studied for use in respiratory disorders, specifically to reduce episodes of worsening symptoms in chronic obstructive pulmonary disease (COPD) patients aged 40 to 80 years old. It is a Phase 2 investigational vaccine developed by GSK plc.
The NTHi Mcat investigational vaccine targets non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat), two bacteria commonly associated with respiratory infections. The vaccine is designed to generate an immune response against these pathogens to help prevent exacerbations in COPD patients.
The NTHi Mcat investigational vaccine is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and efficacy in respiratory disorders.
The NTHi Mcat investigational vaccine is in Phase 2 clinical development. It is an investigational product, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in patients with respiratory disorders.
The NTHi Mcat investigational vaccine has completed two Phase 2 clinical trials. NCT03281876 enrolled 606 COPD patients aged 40 to 80 years to evaluate the vaccine's effect on reducing exacerbations and its safety and immune response. NCT03443427 enrolled 200 current and former smokers to assess the safety and immune response of a third vaccine dose.
The NTHi Mcat investigational vaccine is a specific vaccine candidate developed by GSK for respiratory disorders, including COPD. It is not referred to by other names in the available data, and it is distinct from other GSK vaccines targeting different pathogens or indications.