Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine

NCT05005247 | Completed Phase 1 Results

• 1 other identifier: MVX0003
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5 years after the completion of the primary course of vaccination. All participants will receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein.

Conditions

Group B Streptococcus Infection

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events

  Number of participants with treatment emergent adverse events

  12 weeks (Day 85)

Secondary Outcomes (4)

• Treatment Emergent Adverse Events

  6 months (Day 183)

• Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values)

  From Day 1 to Day 85

• Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase)

  From Day 1 to Day 85

• Antibody Concentration Specific for GBS-NN and GBS-NN2

  MVX002 day 85, MVX003 day 1 and MVX003 day 85

Study Arms (1)

GBS-NN/NN2

EXPERIMENTAL

Single dose 0.5 millilitre (mL) intramuscular injection of GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2

Biological: GBS-NN/NN2

Interventions

GBS-NN/NN2 BIOLOGICAL

GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2

GBS-NN/NN2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be confirmed at Screening:
• Women who have participated in study MVX0002, with GBS-NN/NN2 vaccine and received active vaccine or placebo (unless it is necessary to recruit vaccine naïve participants to bolster the number of participants who received placebo in MVX0002).
• Able to voluntarily provide written informed consent to participate in the study.
• Healthy female participants aged 18-40 years (vaccine naïve participants only).
• Female participant of childbearing potential willing to use a highly effective method of contraception (in addition to a condom for male partners), if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the first dose until completion of the Day 85 visit. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. For the purposes of this study, this definition of a female of childbearing potential applies to all females in the study i.e., those who participated in the MVX0002 study and those who are considered vaccine naïve.
• Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy).
• Female participant with a negative pregnancy test at Screening and prior to dose.
• Female participant of menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range. In the event a participant's menopausal status has been clearly established (for example, the participant indicates she has been amenorrhoeic for 10 years, confirmed by medical history, etc), but serum FSH levels are not consistent with a postmenopausal status, determination of the participant's eligibility to be included in the study will be at the Investigator's discretion following consultation with the Sponsor.
• Body mass index (BMI) ≥18 and ≤30 kg/m2 (vaccine naïve participants only).
• Participants' weight ≥ 50 kg and ≤ 100 kg at Screening (vaccine naïve participants only).
• Non-smokers for at least 3 months prior to study vaccine administration.
• No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before dose administration of the IMP.
• Participants with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before dose administration of the IMP (N.B.: A positive test result may be repeated at the Investigator's discretion, if on prescribed opiates resulting in a positive test, participants may be eligible at the investigators discretion).
• No clinically significant abnormalities in vital signs (supine blood pressure/heart rate, respiration rate, tympanic temperature) determined within 28 days before dose of IMP.
• Participants with a negative coronavirus (COVID-19) Reverse Transcription Polymerase Chain Reaction (RT-PCR) test on admission (Day 1 or Day-1 if deemed appropriate by the Principal Investigator (PI)) if required at the time.

You may not qualify if:

• To be confirmed at Screening:
• Participants who have an autoimmune disease.
• Participants who have a current infection or any significant illness at Screening (such participants can be rescreened once the active infection or significant illness has resolved).
• Participants 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.
• Laboratory values at Screening which are deemed by the Investigator to be clinically significantly abnormal.
• Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
• Participation in a clinical drug study during the 90 days or 5 half-lives, whichever is longer, preceding the initial dose in this study (such participants can be rescreened once the 90-day or 5 half-lives period has elapsed).
• Participants with a history of severe allergic reactions after previous vaccination.
• Participants with a history of hypersensitivity to the Investigational Medicinal Product (IMP) or any of the excipients within the IMP or documented allergy to aminoglycosides.
• Participants who have received any vaccine within 7 days of dosing, or who are planning to receive a vaccine up to 7 days after receiving the GBS-NN/NN2 vaccine.
• Participants who have received immunosuppressive therapy within the 6 months prior to Screening.
• Participants with tattoos at the proposed site of vaccine administration.
• Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.
• Pregnant or breast feeding.
• Current or history of drug or alcohol abuse, or a positive urine alcohol test prior to dosing (prescribed opiates are acceptable).

Sponsors & Collaborators

• Minervax ApS: lead

Study Sites (1)

Simbec Clinical Pharmacology

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

Location

Results Point of Contact

• Title: CMO
• Organization: MinervaX

LIO@minervax.com

004553883002

Study Officials

• Geoff Kitson

  gkitson@propharmapartners.uk.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label booster vaccine study

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: August 17, 2021
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-07

Locations

GB (1)