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GSK's investigational non-typeable Haemophilus influenzae and Moraxella catarrhalis multi-antigen vaccine adjuvanted with AS01E · 1 trial · 1 indication
Antibody concentrations as measured by ELISA (Enzyme-linked immunosorbent assay) and expressed as adjusted (ANCOVA model) GMCs in ELISA units per milliliter (EU/mL). Cut-off value for the assay is 153, 16, 8 and 28 EU/mL for Anti-PD, Anti-PE, Anti-PilA and Anti-UspA2 antibodies respectively. The ANCOVA model includes study group, smoking status (current or former), age category (50-59, 60-69, 70-80 years of age) and center as factors and the antibody concentration before Dose 1 as covariate. As per protocol set (PPS) sample size was not met in Sh\_NTHi\_Mcat\_3 and Sh\_NTHi-Mcat\_6 groups then timeframe was adapted as follows: At 1 month after dose 2 of NTHi-Mcat vaccine (Day 181 in Sh\_NTHi-Mcat\_1 group and Day 91 in NTHi-Mcat group)
| Arm | Type | Description |
|---|---|---|
| Sh_NTHi-Mcat_1 Group | EXPERIMENTAL | Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151. |
| Sh_NTHi-Mcat_3 Group | EXPERIMENTAL | Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211. |
| Sh_NTHi-Mcat_6 Group | EXPERIMENTAL | Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301. |
| NTHi-Mcat Group | ACTIVE_COMPARATOR | Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61. |
| Shingrix-Only Group | EXPERIMENTAL | Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHI Mcat investigational vaccine. Only safety data were collected for these subjects. |
| Name | Type | Description |
|---|---|---|
| GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E | BIOLOGICAL | 2 doses of the investigational NTHi-Mcat vaccine will be administered 2 months apart to all subjects in all the groups. The vaccine will be given intramuscularly (IM) in the upper deltoid of non-dominant arm |
| Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A) | BIOLOGICAL | 2 doses of the Shingrix vaccine will be administered at days 1 and 61 to all subjects in groups Sh\_NTHi-Mcat\_1, 3 and 6. The vaccine will be given intramuscularly (IM) in the upper deltoid 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 (e.g. completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the subject prior to performance of any study specific proced...
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It is an investigational vaccine developed by GSK plc that combines multiple antigens from non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat), two bacteria associated with respiratory disorders. The vaccine is formulated with the AS01E adjuvant system and is given to healthy smokers and ex-smokers aged 50 years and older.
It is being studied for the prevention of respiratory disorders linked to non-typeable Haemophilus influenzae and Moraxella catarrhalis infection. The Phase 2 trial enrolled healthy smokers and ex-smokers aged 50 years and older, a population at elevated risk of respiratory conditions. It is investigational and has not been approved for any use.
GSK plc, which trades under the ticker GSK, is the developer of this investigational vaccine. The candidate is also identified by the code GSK3277511A and uses the AS01E adjuvant system, the same adjuvant platform GSK uses in several of its vaccine programs.
It is in Phase 2 development. One Phase 2 trial, NCT03894969, has been completed, and no trials are currently active. The study was randomized and active-controlled, with 541 participants enrolled across Estonia, Finland, France, Italy and Spain. The vaccine remains investigational and is not approved.
The Phase 2 trial NCT03894969 assessed the immunogenicity and safety of GSK3277511A in healthy smokers and ex-smokers after administration of the Shingrix vaccine. It enrolled 541 participants aged 50 years and older of all sexes, was randomized with an active control, and has been completed. Trial sites were in Estonia, Finland, France, Italy and Spain.