NCT02572635

Brief Summary

Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses or lungs. It can also cause more serious infections of the blood or brain. The elderly and young children are more vulnerable to these types of infections. The vaccines available at present are effective only on a certain number of strains of the bacteria. The PnuBioVax vaccine is being developed to work on a broader range of strains. This study will be looking at the safety and tolerability of the study drug for three different dosages: 50 μg, 200 μg, and 500 μg compared to placebo. The population eligible to take part in the study are healthy male and female subjects between 18 and 40 years of age. Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing. Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Only subjects who agree to undertake precautions to avoid pregnancy of either themselves of their partner during the study period will be eligible. Volunteers will give signed consent for their physician to be notified about their participation in the trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 6, 2015

Last Update Submit

October 4, 2016

Conditions

Pneumococcal Infection

Keywords

Pneumococcal InfectionPhase IImmunogenicitySafetyVaccination

Outcome Measures

Primary Outcomes (1)

  • Incidence of all treatment emergent adverse events

    Number of subjects with adverse events reported from first dosing to last follow up visit.

    Baseline to Day 85

Secondary Outcomes (1)

  • The proportion of subjects who develop an immune response to PnuBioVax

    Baseline to Day 85

Other Outcomes (4)

  • Measurement of antibody production against specific pneumococcal proteins.

    Baseline to Day 85

  • Measurement of the percentage inhibition by serum of the haemolytic activity of pneumolysin.

    Baseline to Day 85

  • Measurement of IL-17 production following stimulation of peripheral blood mononuclear cells with PnuBioVax.

    Baseline to Day 85

  • +1 more other outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

50 µg of PnuBioVax

Biological: PnuBioVax

Cohort 2

EXPERIMENTAL

200 µg of PnuBioVax

Biological: PnuBioVax

Cohort 3

EXPERIMENTAL

500 µg of PnuBioVax

Biological: PnuBioVax

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

PnuBioVaxBIOLOGICAL

Three administrations (by intramuscular injection) given 28 days apart to 9 subjects.

Cohort 1Cohort 2Cohort 3
PlaceboBIOLOGICAL

Placebo administered by intramuscular injection to 3 subjects in each cohort. Three administrations given 28 days apart.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male and female subjects between 18 and 40 years of age (inclusive).
  • female subjects of child bearing potential with negative pregnancy test at screening and willing to use 2 effective methods of contraception (i.e. established method of contraception plus condom, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.
  • male subjects willing to use 2 effective methods of contraception unless anatomically sterile, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject, from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.
  • subjects with a Body Mass Index (BMI) of \<30 kg/m2.
  • subjects with a negative urinary drugs of abuse screen determined within 28 days of the first dose.
  • subjects with negative HIV and Hepatitis B and C results.
  • subjects must be willing and able to comply with the requirements of the protocol and must be available to complete the trial, including all follow up visits.
  • subject must provide written informed consent to participate in the trial.

You may not qualify if:

  • any relevant abnormality in medical history examination, vital signs laboratory tests or ECG.
  • any reason that would make the assessment of any injection site reaction difficult (e.g. tattoos at injections site, black skin).
  • history of migraine or asthma (no inhaler use for 5 years).
  • proven diagnosis of pneumonia within last 5 years.
  • current smokers.
  • history of anaphylaxis or hypersensitivity to previous vaccinations.
  • known impairment of the immune system or chronic diseases, e.g. autoimmune diseases, diabetes, cancer.
  • anticipation that the subject may require any other vaccination during the trial period.
  • subjects who are antinuclear antibody (ANA) positive (above a titre of 1:80).
  • subjects with haemoglobin level \< 8.4 mmol/ L (males) and \<7.8 mmol/L (females).
  • palpable cervical or axillary lymph nodes.
  • receipt of regular prescribed medication within 28 days of the first trial day and / or receipt of vitamins, minerals, herbal remedies and nutritional supplements within 7 days of the first trial day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simbec Research Ltd

Merthyr Tydfil, Glamorgan, CF48 4DR, United Kingdom

Location

Related Publications (1)

  • Entwisle C, Hill S, Pang Y, Joachim M, McIlgorm A, Colaco C, Goldblatt D, De Gorguette D'Argoeuves P, Bailey C. Safety and immunogenicity of a novel multiple antigen pneumococcal vaccine in adults: A Phase 1 randomised clinical trial. Vaccine. 2017 Dec 18;35(51):7181-7186. doi: 10.1016/j.vaccine.2017.10.076. Epub 2017 Nov 10.

    PMID: 29132988DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Christopher Bailey, Bsc, PhD

    Sponsor (ImmunoBiology Ltd)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 9, 2015

Study Start

October 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations

GB(1)