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A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax

NCT02572635 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-10-05

No results posted yet for this study

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.

Conditions

  • Pneumococcal Infection

Interventions

BIOLOGICAL

PnuBioVax

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Oxford Therapeutics Consulting Limited

    collaborator INDUSTRY

  • ORION Clinical Services

    collaborator INDUSTRY

  • ImmunoBiology Limited

    lead INDUSTRY

Principal Investigators

  • Christopher Bailey, Bsc, PhD · Sponsor (ImmunoBiology Ltd)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02572635 on ClinicalTrials.gov