Phase 1
Completed N=81
A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults
Source: ClinicalTrials.gov NCT03201211 ↗Enrolled (actual)
81
Serious AEs
11.1%
Results posted
Apr 2021
Primary outcomePrimary: Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine — 382.7; 511.9; 90.5 EU/mL
Summary
The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71 years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a 0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received saline placebo controls will also be included in this follow-up study to make comparisons with the investigational vaccines. No vaccinations will be administered in this trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
382.7; 511.9; 90.5 | — |
| PRIMARY Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
315.4; 474.5; 101.5 | — |
| PRIMARY Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
315.4; 474.5; 101.5 | — |
| PRIMARY Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
315.4; 474.5; 101.5 | — |
| PRIMARY Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
315.4; 474.5; 101.5 | — |
| PRIMARY Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
315.4; 474.5; 101.5 | — |
| PRIMARY Anti-Protein E (PE) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
762.7; 1215; 21.5 | — |
| PRIMARY Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
491.3; 827.8; 22 | — |
| PRIMARY Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
491.3; 827.8; 22 | — |
| PRIMARY Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
491.3; 827.8; 22 | — |
| PRIMARY Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
491.3; 827.8; 22 | — |
| PRIMARY Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
491.3; 827.8; 22 | — |
| PRIMARY Anti-type IV Pili Subunit (PilA) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
121.9; 188.3; 13.8 | — |
| PRIMARY Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
54.2; 106.5; 9.8 | — |
| PRIMARY Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
54.2; 106.5; 9.8 | — |
| PRIMARY Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
54.2; 106.5; 9.8 | — |
| PRIMARY Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
54.2; 106.5; 9.8 | — |
| PRIMARY Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
54.2; 106.5; 9.8 | — |
| PRIMARY Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
719; 578.2; 456.1 | — |
| PRIMARY Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
536.8; 404.5; 374.9 | — |
| PRIMARY Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
536.8; 404.5; 374.9 | — |
| PRIMARY Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
536.8; 404.5; 374.9 | — |
| PRIMARY Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
536.8; 404.5; 374.9 | — |
| PRIMARY Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine |
536.8; 404.5; 374.9 | — |
| SECONDARY Number of Subjects Reported With Any Serious Adverse Event (SAE) |
5; 2; 2 | — |
| SECONDARY Number of Subjects Reported With Any Potential Immune-mediated Disease (pIMD) |
0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who previously participated in STEP 2 of study NTHi-Mcat-001 (201281), and performed the last study visit (Month 14) and received the 2 study vaccinations.
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits). And subjects' Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Written informed consent obtained from the subject/ LAR(s) of the subject prior to performance of any study specific procedure.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) during the period starting 30 days before the first follow-up study visit (Month 19 to Month 20), or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since the end of the NTHi-Mcat-001 study. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first follow-up visit or planned administration during the study period.
- Current alcoholism and/or drug abuse.
- Has significant disease (including significant neurological or psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
- Any other condition that the investigator judges may interfere with study findings.
Data sourced from ClinicalTrials.gov (NCT03201211). 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.