Phase 2
Completed N=541
Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine
Source: ClinicalTrials.gov NCT03894969 ↗Enrolled (actual)
541
Serious AEs
5.9%
Results posted
Sep 2021
Primary outcomePrimary: Anti-Protein D (PD), Anti-Protein E (PE), Anti-type IV Pili Subunit (PilA) and Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Adjusted Geometric Mean Concentrations (GMCs), One-month Post Dose-2 of NTHi-Mcat Vaccine — 1402.804; 1489.531; 6234.827; 7032.52 EU/mL
Summary
This study will provide information regarding the sequential administration of two vaccines adjuvanted with AS01.
The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when administered sequentially after Shingrix vaccine and to compare to the immunogenicity of NTHi-Mcat vaccine administered alone. This study will also provide information regarding whether a specific time period is required between the administration of these two different vaccines containing the same adjuvant- AS01 components.
The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of age which will be used as a proxy for the COPD population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-Protein D (PD), Anti-Protein E (PE), Anti-type IV Pili Subunit (PilA) and Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Adjusted Geometric Mean Concentrations (GMCs), One-month Post Dose-2 of NTHi-Mcat Vaccine |
1402.804; 1489.531; 6234.827; 7032.52; 1244.373; 1089.799 | — |
| SECONDARY Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, Before First NTHi-Mcat Vaccine |
94.7; 105.1; 95.6; 105.3; 22; 21.2 | — |
| SECONDARY Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, One-month Post Dose-2 of NTHi-Mcat Vaccine |
1496.7; 1504; 1539; 1683.5; 5911.8; 5920.8 | — |
| SECONDARY Percentage of Seropositive Subjects for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies Before First NTHi-Mcat Vaccine |
16.9; 20; 19.2; 21.8; 57.6; 63.5 | — |
| SECONDARY Percentage of Subjects Seropositive for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies, One-month Post Dose-2 of NTHi-Mcat Vaccine |
99.2; 97.9; 100; 100; 100; 100 | — |
| SECONDARY Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi and Mcat Antigens for Evaluation of Cell-mediated Immune (CMI) Response, Before First Dose of NTHi-Mcat Vaccine |
112.945; 101.739; 81.578; 92.685; 89.456; 59.522 | — |
| SECONDARY Frequency of CD4+ T-cells Against NTHi and Mcat Antigens for Evaluation of CMI Response, at One-month Post Dose 2 of NTHi-Mcat Vaccine |
721.851; 619.68; 1001.839; 735.177; 632.849; 527.26 | — |
| SECONDARY Percentage of Subjects With Reported Solicited Local Adverse Event (AE) |
6; 15; 11; 12.6; 12.8; 13.7 | — |
| SECONDARY Percentage of Subjects With Reported Solicited General AE |
11.9; 12; 16.9; 7.4; 25.6; 26 | — |
| SECONDARY Percentage of Subjects With Any Unsolicited AE |
13.4; 14.9; 11.5; 18.5; 15; 15.3 | — |
| SECONDARY Percentage of Subjects With Any Serious Adverse Event (SAE) During Epoch 001 |
4.5; 3.7; 2.5; 1.5; 6.3 | — |
| SECONDARY Percentage of Subjects With Any Potential Immune-mediated Diseases (pIMD's) During Epoch 001 |
0; 1.5; 0.8; 0; 12.5 | — |
| SECONDARY Percentage of Subjects With Any SAE During Epoch 002 |
3.0; 4.5; 3.3; 2.2; 0.0 | — |
| SECONDARY Percentage of Subjects With Any pIMD's During Epoch 002 |
0.7; 0.7; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
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 procedure.
- A male or female between, and including, 50 years and 80 years of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Current or former smoker with a cigarette smoking history ≥10 pack-years.
- Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and; has a negative pregnancy test on the day of vaccination, and; has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria
- Medical conditions
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of potential immune-mediated disease (pIMD). Note: If the subject has any condition on the list of pIMDs specified in the protocol, they must be excluded unless the aetiology is clearly documented to be non-immune mediated.
The investigator will exercise his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin and thus meet the exclusion criteria.
- Diagnosis of COPD regardless of severity.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex -gloves, syringes, etc).
- Has significant disease (including significant psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
- History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
- Malignancies within previous 5 years (excluding non-melanoma skin cancer) or lymphoproliferative disorders.
- Prior/concomitant therapy
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of non-MF59 adjuvanted influenza vaccines and pneumococcal vaccines which may be administered ≥15 days preceding or following any study vaccine dose.
Note: For M59 adjuvanted flu vaccine and for any vaccine containing novel adjuvant refer to exclusion criteria below.
- Planned administration/administration of a vaccine adjuvanted with the following adjuvants AS01, AS02, AS03, AS04 and MF59 in the period starting 6 months before the first dose of study vaccine, and ending at the second blood draw (i.e. approximately 1 month after the administration of the last dose of NTHi-Mcat vaccine). The following non-exhaustive list should be considered as criteria for exclusion: Prepandrix, Adjupanrix, Shingrix, Fendrix, Cervarix, FluAd, Chiromas, Gripguard.
- Previous vaccination with any vaccine containing NTHi and/or Mcat antigens
- Previous vaccination with Shingrix; (either registered product or participation in a previous vaccine study).
Data sourced from ClinicalTrials.gov (NCT03894969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.