IVT GBS-06 Vaccine for Asymptomatic Carriers

Recruiting at 1 trial location

Overseen By Indah Andi-Lolo

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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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 of childbearing age (WOCBA).

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 the IVT GBS-06 vaccine safe for humans?

The research articles discuss Guillain-Barré syndrome (GBS), a rare nerve disorder, as a potential side effect of some vaccines, particularly those using viral vectors like the AstraZeneca COVID-19 vaccine. However, these findings are specific to certain vaccines and do not provide direct safety data for the IVT GBS-06 vaccine. ^{1 2 3 4 5}

Research Team

Sybil Tasker, MD, MPH, FIDSA

Principal Investigator

Inventprise Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Rare cases of Guillain-Barré syndrome after COVID-19 vaccination, Germany, December 2020 to August 2021. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Guillain-Barré syndrome temporally associated with COVID-19 vaccines in Victoria, Australia. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Guillain-Barré syndrome after AstraZeneca COVID-19-vaccination: A causal or casual association? [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Population-Based Incidence of Guillain-Barré Syndrome During Mass Immunization With Viral Vaccines: A Pooled Analysis. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Reports of Guillain-Barre Syndrome Following COVID-19 Vaccination in the USA: An Analysis of the VAERS Database. [2023]