Last updated: 11/25/2021 05:30:06
A long term follow-up study up to 4 years after study vaccination to assess immunogenicity and safety of the investigational vaccine in adults
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A long-term follow-up study of the investigational GSK Biologicals’ GSK3277511A vaccine in adults
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Anti-Protein D (PD) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 20
Anti-PD antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 26
Anti-PD antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 32
Anti-PD antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 38
Anti-PD antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 44
Anti-PD antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 50
Anti-Protein E (PE) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 20
Anti-PE antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 26
Anti-PE antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 32
Anti-PE antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 38
Anti-PE antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 44
Anti-PE antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 50
Anti-type IV pili subunit (PilA) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 20
Anti-PilA antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 26
Anti-PilA antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 32
Anti-PilA antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 38
Anti-PilA antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 44
Anti-PilA antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 50
Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 20
Anti-UspA2 antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 26
Anti-UspA2 antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 32
Anti-UspA2 antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 38
Anti-UspA2 antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 44
Anti-UspA2 antibody concentrations, measured as component of the NTHi Mcat investigational vaccine
Timeframe: At Month 50
Secondary outcomes:
Number of subjects reported with any serious adverse event (SAE)
Timeframe: From first visit (Month 20) up to study conclusion (Month 50)
Number of subjects reported with any potential immune-mediated disease (pIMD)
Timeframe: From first visit (Month 20) up to study conclusion (Month 50)
Interventions:
Biological/vaccine: Blood sampling
Biological/vaccine: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.
Biological/vaccine: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.
Drug: Placebo
Enrollment:
81
Observational study model:
Not applicable
Primary completion date:
2020-19-03
Time perspective:
Not applicable
Clinical publications:
De Smedt P, Leroux-Roels G, Vandermeulen C, Tasciotti A, Di Maro G, Dozot M, Casula D, Annaratone M, Riccucci D, Kumar Arora A. Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase I multicentre trial. Vaccine: X. 2021;9:100124. DOI: http://dx.doi.org/ https://doi.org/10.1016/j.jvacx.2021.100124
Medical condition
Respiratory Disorders
Product
GSK3277511A
Collaborators
Not applicable
Study date(s)
June 2017 to March 2020
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
51 - 73 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2020-19-03
Actual study completion date
2020-19-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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