IVT GBS-06 Vaccine for Asymptomatic Carriers

Not currently recruiting at 1 trial location

Overseen By Angelica C Kottkamp, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Inventprise Inc.

Must not be taking: Immunomodulators, Corticosteroids, others

Disqualifiers: Neurological disease, Depression, Immunodeficiency, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, IVT GBS-06, to determine its safety and tolerability in healthy women who are not pregnant and can have children. The goal is to assess how the body processes the vaccine at three different dose levels. Participants will receive either a low, mid, or high dose of the vaccine, or a placebo, which contains no active ingredients. Women who are perfectly healthy and free from serious health issues may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on long-acting immunomodulating drugs or high-dose systemic corticosteroids, you may need to stop them before joining the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that the IVT GBS-06 vaccine is likely to be safe for humans?

Research shows that the IVT GBS-06 vaccine is being tested for safety and tolerability in healthy women of childbearing potential. The study examines three different doses of the vaccine. Although specific results from these trials are not disclosed, this phase emphasizes safety, indicating the vaccine has already passed initial safety checks in earlier tests.

Earlier lab studies demonstrated that the vaccine can trigger an immune response. However, this phase is crucial to confirm the vaccine's safety for people. Researchers closely monitor participants to quickly identify any side effects or unexpected reactions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the IVT GBS-06 vaccine because it offers a novel approach to preventing Group B Streptococcus (GBS) infections in asymptomatic carriers. Unlike traditional antibiotic treatments that target active infections, this vaccine aims to prevent the bacteria from colonizing in the first place, potentially reducing transmission and subsequent infections. The vaccine is delivered via an intramuscular injection and comes in three different polysaccharide concentrations—low, mid, and high—which allows for tailored dosing based on effectiveness and safety profiles. This proactive method could significantly change how we manage GBS, moving from treatment to prevention.

What evidence suggests that the IVT GBS-06 vaccine could be effective for asymptomatic carriers?

Research has shown that a vaccine like IVT GBS-06 could play a crucial role in preventing group B strep infections, which can be particularly dangerous for newborns and individuals with health issues. The vaccine aims to help the immune system recognize and combat the bacteria responsible for these infections. Although specific results for IVT GBS-06 in humans are still under investigation, similar vaccines have demonstrated promise in reducing these infections. Early indications suggest it might help decrease the rates of GBS colonization, where the bacteria are present in the body without causing symptoms. Participants in this trial will receive different formulations of the IVT GBS-06 vaccine, including low, mid, and high-dose polysaccharide concentrations, or a placebo, to assess its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Sybil Tasker, MD, MPH, FIDSA

Principal Investigator

Inventprise Inc.

Are You a Good Fit for This Trial?

Healthy women aged 18-49 who are not pregnant, breastfeeding, or planning to become pregnant. They must be willing to use contraception and adhere to study visits. Excluded are those with certain medical conditions, drug abuse history, recent fever or acute disease, abnormal lab results, severe allergies to PEG/vaccines, extreme BMI values, or a history of GBS-related diseases.

Inclusion Criteria

I am a healthy woman aged between 18 and 49.

Resides in the study area and able and willing to adhere to all study restrictions and visits

Healthy as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator

Exclusion Criteria

History of major depression disorder not well controlled in the past 2 years

Any other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

I have had a fever or taken fever-reducing medicine in the last 3 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of IVT GBS-06 or placebo administered by intramuscular injection on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and immunogenicity assessments

4 weeks

Multiple visits (in-person and virtual)

Long-term follow-up

Participants are monitored for serious adverse events and medically attended adverse events

Until the end of the study

What Are the Treatments Tested in This Trial?

Interventions

• IVT GBS-06

Trial Overview The trial is testing the safety and tolerability of the IVT GBS-06 vaccine in healthy adult women at three different dosage levels. This vaccine is compared against a placebo in a single-dose regimen to see how participants' bodies react.

How Is the Trial Designed?

Group I: Group 3; GBS-06 (High) Experimental Treatment 1 Intervention

Participants will receive a single 0.5mL dose of IVT GBS-06 Formulation 3 (high dose polysaccharide concentration) administered by intramuscular injection to the non-dominant deltoid muscle on Day 1.

Group II: Group 2; GBS-06 (Mid) Experimental Treatment 1 Intervention

Participants will receive a single 0.5mL dose of IVT GBS-06 Formulation 2 (mid-dose polysaccharide concentration) administered by intramuscular injection to the non-dominant deltoid muscle on Day 1.

Group III: Group 1; GBS-06 (Low) Experimental Treatment 1 Intervention

Participants will receive a single 0.5mL dose of IVT GBS-06 Formulation 1 (low dose polysaccharide concentration) administered by intramuscular injection to the non-dominant deltoid muscle on Day 1.

Group IV: Group 4; Placebo Placebo Group 1 Intervention

Participants will receive a single 0.5mL dose of 0.9% sodium chloride placebo administered by intramuscular injection to the non-dominant deltoid muscle on Day 1.

Who Is Running the Clinical Trial?

Inventprise Inc.

Lead Sponsor

Trials

4

Recruited

1,300+

PATH

Collaborator

Trials

182

Recruited

629,000+

Published Research Related to This Trial

In a case series of 41 reported cases of Guillain-Barré syndrome (GBS) following COVID-19 vaccination in Victoria, Australia, a significant association was found specifically with the adenovirus-vector vaccine Vaxzevria, showing an incidence rate of 1.85 cases per 100,000 doses, which is higher than the expected background rate of 0.39 cases.

The majority of GBS cases (38 out of 41) were linked to Vaxzevria, with symptoms typically appearing 14 days post-vaccination, and fatigue being the most common lingering symptom; this highlights the need for further studies to better understand the risks associated with different COVID-19 vaccine platforms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guillain-Barré syndrome temporally associated with COVID-19 vaccines in Victoria, Australia. Osowicki, J., Morgan, HJ., Harris, A., et al.[2023]

In a study analyzing 214 reported cases of Guillain-Barré syndrome (GBS) after COVID-19 vaccination in Germany, it was found that the vector-based vaccines Vaxzevria and COVID-19 Vaccine Janssen had significantly higher rates of GBS than expected, with standardized morbidity ratios of 3.10 and 4.16, respectively.

Bilateral facial paresis occurred more frequently in GBS cases following vaccination with vector-based vaccines (19.7% for Vaxzevria and 26.1% for COVID-19 Vaccine Janssen) compared to only 6% in cases following the mRNA vaccine Comirnaty, suggesting a potential safety concern with vector-based vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rare cases of Guillain-Barré syndrome after COVID-19 vaccination, Germany, December 2020 to August 2021. Lehmann, HC., Oberle, D., Keller-Stanislawski, B., et al.[2023]

A case of Guillain-Barré syndrome (GBS) was reported following the first dose of the Oxford/AstraZeneca COVID-19 vaccine, highlighting the need for awareness of potential neurological complications associated with vaccinations.

Despite the occurrence of GBS cases post-vaccination, the overall incidence remains low, and public health systems should continue to promote vaccine confidence while ensuring that clinicians recognize and report any adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guillain-Barré syndrome after AstraZeneca COVID-19-vaccination: A causal or casual association? Introna, A., Caputo, F., Santoro, C., et al.[2022]

In a systematic review and meta-analysis of 48 studies involving over 2.1 billion participants, the incidence rate of Guillain-Barré Syndrome (GBS) associated with viral vaccinations was found to be low at 3.09 cases per million persons within six weeks of vaccination.

Subgroup analyses revealed that the incidence rates were particularly low for the influenza vaccine (2.77 per million) and HPV vaccines (2.44 per million), supporting the overall safety of these vaccines and providing a reference for evaluating GBS rates in future vaccination campaigns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population-Based Incidence of Guillain-Barré Syndrome During Mass Immunization With Viral Vaccines: A Pooled Analysis. Wang, F., Wang, D., Wang, Y., et al.[2023]

In 2021, there were 815 reports of Guillain-Barre syndrome and its variants (GBS/V) following COVID-19 vaccination, with 47% classified as definite cases, indicating a notable but not overwhelming association with the vaccine.

Most reported cases had a median onset of 10 days post-vaccination, with 77% requiring hospitalization, but many cases did not fit the typical GBS/V timeline, suggesting that the relationship between vaccination and GBS/V may not be straightforward.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reports of Guillain-Barre Syndrome Following COVID-19 Vaccination in the USA: An Analysis of the VAERS Database. Chalela, JA., Andrews, C., Bashmakov, A., et al.[2023]

Citations

1. withpower.com withpower.com/trial/ivt-gbs-06-vaccine-for-asymptomatic-carriers-bcd3d

IVT GBS-06 Vaccine for Asymptomatic Carriers This Phase 1 & 2 medical study run by Inventprise Inc. needs participants to evaluate whether IVT GBS-06 will have tolerable side effects & efficacy for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06611371

NCT06611371 | Phase I/II Study to a Assess the GBS-06 ... To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5795048/

Status of group B streptococcal vaccine development - PMC Application of a GBS vaccine is the most promising strategy for the prevention of GBS infections in both newborns and adults with underlying diseases. However, ...

4. trialx.com trialx.com/clinical-trials/listings/305890/phase-iii-study-to-a-assess-the-gbs-06-vaccine-manufactured-by-inventprise-inc-in-healthy-non-pregnant-adult-women-of-childbearing-age/

Phase I/II Study to a Assess the GBS-06 Vaccine ... These four study groups will be enrolled simultaneously to allow for parallel assessments of overall IVT GBS-06 safety and tolerability.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06611371/phase-i-ii-study-to-a-assess-the-gbs-06-vaccine-manufactured-by-inventprise-inc-in-healthy-non-pregnant-adult-women-of-childbearing-age

Phase I/II Study to a Assess the GBS-06 Vaccine ... These four study groups will be enrolled simultaneously to allow for parallel assessments of overall IVT GBS-06 safety and tolerability.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474038/

Preclinical Immunogenicity of a 6-Valent GBS ... In relation to this, encouraging immunogenicity data have been reported from phase II clinical trial studies of a 6-valent GBS conjugate vaccine ...