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NCT03807245: MVX0002

Group B Streptococcus Vaccine in Healthy Females

Completed Phase 1 Results posted Last updated 2 February 2021
What this trial tests

Phase 1 trial testing GBS-NN/NN2 with Alhydrogel® 25 in Group B Strep Infection in 60 participants. Completed in 7 May 2020.

Timeline
9 January 2019
Primary endpoint
14 October 2019
7 May 2020

Quick facts

Lead sponsorMinervax ApS
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment60
Start date9 January 2019
Primary completion14 October 2019
Estimated completion7 May 2020
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Minervax ApS — full company profile →

Who can join

Adults 18 to 40, female only, with Group B Strep Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events Primary · 85 days

Number of Participants with Treatment Emergent Adverse Events

GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2517
GBS-NN/NN2 With Alhydrogel® 5015
Placebo With Alhydrogel®8
Immunoglobulin(Ig)G Antibody Concentration Secondary · Day 85

Adjusted geometric mean concentration (GMC)

GBS-NN
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2515.211.1 – 20.8
GBS-NN/NN2 With Alhydrogel® 5017.112.5 – 23.4
Placebo With Alhydrogel®0.1150.0746 – 0.177
GBS-NN2
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2524.018.8 – 30.8
GBS-NN/NN2 With Alhydrogel® 5029.923.4 – 38.3
Placebo With Alhydrogel®0.1540.109 – 0.216
Fold Change in Antibody Concentration Secondary · Day 1 to Day 85

Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.

GBS-NN
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 25127.70779.310 – 205.637
GBS-NN/NN2 With Alhydrogel® 50131.52693.987 – 184.057
Placebo With Alhydrogel®0.9510.791 – 1.144
GBS-NN2
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 25169.594104.224 – 275.964
GBS-NN/NN2 With Alhydrogel® 50211.303140.290 – 318.260
Placebo With Alhydrogel®0.9460.838 – 1.068
Seroconversion Rate Secondary · Day 85

4-fold increase in Immunoglobulin(Ig)G antibody concentration

GBS-NN
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2523
GBS-NN/NN2 With Alhydrogel® 5023
Placebo With Alhydrogel®0
GBS-NN2
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2523
GBS-NN/NN2 With Alhydrogel® 5023
Placebo With Alhydrogel®0
Number of Participants With an Immune Response to First and Second Doses Secondary · Day 29 and Day 85

Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds

GBS-NN Day 29 increase above 1mcg/mL
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2519
GBS-NN/NN2 With Alhydrogel® 5023
Placebo With Alhydrogel®0
GBS-NN Day 29 increase above 2mcg/mL
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2519
GBS-NN/NN2 With Alhydrogel® 5020
Placebo With Alhydrogel®0
GBS-NN Day 29 increase above 4mcg/mL
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2517
GBS-NN/NN2 With Alhydrogel® 5017
Placebo With Alhydrogel®0
GBS-NN Day 29 increase above 8mcg/mL
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2513
GBS-NN/NN2 With Alhydrogel® 5013
Placebo With Alhydrogel®0
GBS-NN Day 85 increase above 1mcg/mL
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2523
GBS-NN/NN2 With Alhydrogel® 5023
Placebo With Alhydrogel®0
GBS-NN Day 85 increase above 2mcg/mL
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2520
GBS-NN/NN2 With Alhydrogel® 5023
Placebo With Alhydrogel®0
GBS-NN Day 85 increase above 4mcg/mL
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2520
GBS-NN/NN2 With Alhydrogel® 5021
Placebo With Alhydrogel®0
GBS-NN Day 85 increase above 8mcg/mL
GroupValue95% CI
GBS-NN/NN2 With Alhydrogel® 2518
GBS-NN/NN2 With Alhydrogel® 5020
Placebo With Alhydrogel®0

Adverse events — posted to ClinicalTrials.gov

Time frame: 85 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GBS-NN/NN2 With Alhydrogel® 25
Serious: 0/24 (0%)
Deaths: 0/24
GBS-NN/NN2 With Alhydrogel® 50
Serious: 0/24 (0%)
Deaths: 0/24
Placebo With Alhydrogel®
Serious: 0/12 (0%)
Deaths: 0/12
Other adverse events (37 terms — click to expand)

ReactionSystemGBS-NN/NN2 With Alhydrogel…GBS-NN/NN2 With Alhydrogel…Placebo With Alhydrogel®
HeadacheNervous system disorders———
NasopharyngitisInfections and infestations———
DysmenorrhoeaReproductive system and breast disorders———
Influenza like illnessGeneral disorders———
NauseaGastrointestinal disorders———
InfluenzaInfections and infestations———
Vulvovaginal candidiasisInfections and infestations———
Oropharyngeal painRespiratory, thoracic and mediastinal disorders———
PalpitationsCardiac disorders———
Abdominal distensionGastrointestinal disorders———
Allergy to animalImmune system disorders———
Gastroenteritis viralInfections and infestations———
Ligament sprainInjury, poisoning and procedural complications———
Carpal tunnel syndromeNervous system disorders———
AnxietyPsychiatric disorders———
DyspepsiaGastrointestinal disorders———
VomitingGastrointestinal disorders———
PainGeneral disorders———
PyrexiaGeneral disorders———
Lower respiratory tract infectionInfections and infestations———
PharyngitisInfections and infestations———
TonsillitisInfections and infestations———
Upper respiratory tract infectionInfections and infestations———
Urinary tract infectionInfections and infestations———
Viral infectionInfections and infestations———
Post-traumatic neck syndromeInjury, poisoning and procedural complications———
ArthralgiaMusculoskeletal and connective tissue disorders———
Back painMusculoskeletal and connective tissue disorders———
Musculoskeletal chest painMusculoskeletal and connective tissue disorders———
Neck painMusculoskeletal and connective tissue disorders———
Pain in extremityMusculoskeletal and connective tissue disorders———
DizzinessNervous system disorders———
LethargyNervous system disorders———
MigraineNervous system disorders———
Sleep disorderPsychiatric disorders———
HypomenorrhoeaReproductive system and breast disorders———
CoughRespiratory, thoracic and mediastinal disorders———

Data from ClinicalTrials.gov NCT03807245 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Systematic review of Group B Streptococcal capsular types, sequence types and surface proteins as potential vaccine candidates.
    Bianchi-Jassir F, Paul P, To KN, Carreras-Abad C, et al · · 2020 · cited 98× · PMID 32888741 · DOI 10.1016/j.vaccine.2020.08.052
  2. Bacterial and Host Determinants of Group B Streptococcal Vaginal Colonization and Ascending Infection in Pregnancy.
    Brokaw A, Furuta A, Dacanay M, Rajagopal L, et al · · 2021 · cited 57× · PMID 34540718 · DOI 10.3389/fcimb.2021.720789
  3. The role of immune correlates of protection on the pathway to licensure, policy decision and use of group B Streptococcus vaccines for maternal immunization: considerations from World Health Organization consultations.
    Vekemans J, Crofts J, Baker CJ, Goldblatt D, et al · · 2019 · cited 47× · PMID 31031031 · DOI 10.1016/j.vaccine.2019.04.039
  4. The impact of human vaccines on bacterial antimicrobial resistance. A review.
    Jansen KU, Gruber WC, Simon R, Wassil J, et al · · 2021 · cited 39× · PMID 34602924 · DOI 10.1007/s10311-021-01274-z
  5. A Recombinant Alpha-Like Protein Subunit Vaccine (GBS-NN) Provides Protection in Murine Models of Group B Streptococcus Infection.
    Brokaw A, Nguyen S, Quach P, Orvis A, et al · · 2022 · cited 20× · PMID 35429401 · DOI 10.1093/infdis/jiac148
  6. Safety and immunogenicity of the group B <i>streptococcus</i> vaccine AlpN in a placebo-controlled double-blind phase 1 trial.
    Gonzalez-Miro M, Pawlowski A, Lehtonen J, Cao D, et al · · 2023 · cited 19× · PMID 36915681 · DOI 10.1016/j.isci.2023.106261
  7. Updates on Group B <i>Streptococcus</i> Infection in the Field of Obstetrics and Gynecology.
    Choi Y, Han HS, Chong GO, Le TM, et al · · 2022 · cited 11× · PMID 36557651 · DOI 10.3390/microorganisms10122398
  8. Identifying large-scale recombination and capsular switching events in &lt;i&gt;Streptococcus agalactiae&lt;/i&gt; strains causing disease in adults in the UK between 2014 and 2015.
    Khan UB, Jauneikaite E, Andrews R, Chalker VJ, et al · · 2022 · cited 8× · PMID 35290175 · DOI 10.1099/mgen.0.000783

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Other recruiting trials for Group B Strep Infection

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing