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
Study complete
Study complete
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:
Enrollment:
81
Primary completion date:
2020-19-03
Observational study model:
Not applicable
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
Study complete
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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