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Group B Streptococcus Vaccine in Healthy Females (MVX0002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03807245
Recruitment Status : Active, not recruiting
First Posted : January 16, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Simbec Research
Information provided by (Responsible Party):
Minervax ApS

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE January 9, 2019
Estimated Primary Completion Date September 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
Incidence of treatment emergent adverse event [ Time Frame: 85 days ]
The change from Baseline will be assessed at Day 85
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03807245 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
Geometric mean antibody concentration in μg/mL [ Time Frame: 85 days ]
Change from Baseline to day 85 mean folding increase
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group B Streptococcus Vaccine in Healthy Females
Official Title  ICMJE A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Group B Streptococcus Vaccine (GBS-NN/NN2 With Alhydrogel®) in Healthy Female Subjects Aged 18 to 40
Brief Summary A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.
Detailed Description

There will be 4 arms in 2 cohorts of 30 subjects. Cohort 1 will receive two 0.5 mL injections, 4 weeks apart, each consisting of 25 μg of GBS-NN and 25 μg of GBS-NN2 (24 subjects) or placebo (6 subjects). Cohort 2 (30 subjects) will receive two 0.5 mL injections, 4 weeks apart, each consisting of 50 μg of GBS-NN and 50 μg of GBS-NN2 (24 subjects) or placebo (6 Subjects). All vaccines will be adsorbed to 500 μg Al3+ as Alhydrogel®.

Safety will be assessed after all subjects have completed Visit 4 (Day 8) for Cohort 1, at which point the decision will be made as to whether proceeding with administration of the doses in cohort 2 is appropriate.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Group B Strep Infection
Intervention  ICMJE
  • Biological: GBS-NN/NN2 with Alhydrogel® 25
    GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
  • Biological: Placebo GBS-NN/NN2 with Alhydrogel® 25
    GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
  • Biological: Placebo GBS-NN/NN2 with Alhydrogel® 50
    GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
  • Biological: GBS-NN/NN2 with Alhydrogel® 50
    GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
Study Arms  ICMJE
  • Experimental: GBS-NN/NN2 with Alhydrogel® 25
    GBS-NN/NN2 with Alhydrogel® 25 mcg intramuscular 2 times with 4 weeks apart
    Intervention: Biological: GBS-NN/NN2 with Alhydrogel® 25
  • Placebo Comparator: Placebo GBS-NN/NN2 with Alhydrogel® 25
    Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart
    Intervention: Biological: Placebo GBS-NN/NN2 with Alhydrogel® 25
  • Experimental: GBS-NN/NN2 with Alhydrogel® 50
    Intramuscular GBS-NN/NN2 with Alhydrogel® injection 50 mcg 2 times with 4 weeks apart
    Intervention: Biological: GBS-NN/NN2 with Alhydrogel® 50
  • Placebo Comparator: Placebo GBS-NN/NN2 with Alhydrogel® 50
    Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart
    Intervention: Biological: Placebo GBS-NN/NN2 with Alhydrogel® 50
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 15, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 25, 2020
Estimated Primary Completion Date September 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy female subjects aged 18 - 40 years.
  2. Body mass index (BMI) ≥18 and ≤30 kg/m2.
  3. Subjects weight ≥50kg and ≤100kg at screening.
  4. Able to voluntarily provide written informed consent to participate in the study.
  5. Subjects are pre-menopausal.
  6. Females of childbearing potential must have a negative pregnancy test at screening (β HCG) and prior to each dose. To prevent pregnancy female subjects of childbearing potential must take adequate contraceptive precautions for the entire duration of study participation (up to Day 85). Adequate and highly effective contraceptive precautions include:

    • Established use of oral, injected or implanted hormonal methods of contraception.
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    • Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    • Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female subjects, the vasectomised male partner should be the sole partner for that subject].
    • True abstinence, when this is in line with the preferred and usual lifestyle of the subject.

    [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].

    • The chosen contraception method(s) must be followed from the first dose until at least Day 85 of the study.

  7. Non-smokers for at least 3 months prior to first study vaccine administration.

Exclusion Criteria:

  1. Subjects who have received GBS-NN vaccine previously.
  2. Subjects with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
  3. Pregnant or lactating females.
  4. Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
  5. Positive drug screen for drugs of abuse or a positive alcohol urine test prior to first dosing unless there is a documented medical explanation for the positive result other than drugs of abuse (e.g., the subject has been prescribed opioids for pain).
  6. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
  7. Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
  8. Any significant illness during the 4 weeks preceding check-in for this study (Day 1).
  9. Subjects with a history of allergic reactions after previous vaccination.
  10. Subjects who have received any vaccine within 30 days of screening, or who are planning to receive a vaccine up to Day 85 of the study.
  11. Subjects receiving immunosuppressive therapy in the 6 months prior to screening, taking any short-term medications including over-the-counter (OTC) preparations, within 7 days of the first dose. Chronic medications such as antihypertensives, bronchodilators, oral contraceptives or statins that do not affect the immune system, will be permitted and allowed to continue during the study at the discretion of the Investigator. Paracetamol will be permitted for the treatment of headache or other symptoms. Use of OTC vitamins and dietary supplements is allowed
  12. Subjects with tattoos at the proposed site of vaccine administration.
  13. Donation of blood or blood products within 90 days prior to vaccine administration or intending to donate blood or blood products within 90 days of the last visit.
  14. Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03807245
Other Study ID Numbers  ICMJE 2017-003871-27
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Minervax ApS
Study Sponsor  ICMJE Minervax ApS
Collaborators  ICMJE Simbec Research
Investigators  ICMJE
Study Director: Geoff Kitson gkitson@propharmapartners.uk.com
PRS Account Minervax ApS
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP