Hia Vaccine for Haemophilus Infections

Recruiting at 1 trial location

Overseen By Luis Barreto, MBBS, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: InventVacc Biologicals Inc.

Must not be taking: Glucocorticoids, Antihistamines, Prophylactic medications, others

Disqualifiers: Autoimmune diseases, Neurologic disorders, Cancer, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, if you have had any significant changes in chronic medication in the last three months due to uncontrolled symptoms or drug toxicity, you may be excluded. Also, certain medications like systemic glucocorticoids, immunosuppressants, and investigational products are restricted. Please discuss your specific medications with the trial investigator.

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 have had any significant changes in your chronic medication recently, it might affect your eligibility. It's best to discuss your specific medications with the trial staff.

What data supports the idea that Hia Vaccine for Haemophilus Infections is an effective treatment?

The available research does not provide any data on the effectiveness of the Hia Vaccine for Haemophilus Infections. Instead, the studies focus on hearing aids and their outcomes, which are unrelated to the Hia Vaccine. Therefore, there is no information here to support the effectiveness of the Hia Vaccine for treating Haemophilus Infections. ^{1 2 3 4 5}

What safety data exists for the Hia Vaccine?

The provided research does not contain specific safety data for the Hia Vaccine. It discusses the development and potential impact of a vaccine for Haemophilus influenzae serotype a (Hia) but does not provide details on safety evaluations or clinical trial results for the vaccine. ^{6 7 8 9 10}

Is the Hia Vaccine a promising treatment for Haemophilus infections?

Yes, the Hia Vaccine is a promising treatment because it aims to prevent infections caused by Haemophilus influenzae serotype a, which has become more common since the introduction of vaccines for other serotypes. The development of this vaccine could help reduce the spread of the disease, especially in children, and improve public health by potentially eliminating the pathogen through widespread vaccination. ^{6 7 8 10 11}

How is the Hia Vaccine treatment different from other treatments for Haemophilus infections?

The Hia Vaccine is unique because it is a new protein-polysaccharide conjugate vaccine specifically designed to prevent infections caused by Haemophilus influenzae serotype a (Hia), for which no vaccine currently exists. Unlike existing treatments that rely on antibiotics after infection, this vaccine aims to prevent the disease by inducing immunity before exposure. ^{6 7 8 10 11}

What is the purpose of this trial?

Haemophilus influenzae serotype a (Hia) has emerged as a leading cause of serious illness in Indigenous children in Canada and Alaska in recent decades. In hospital-based surveillance studies, Hia was the most common cause of invasive disease, resulting in morbidity or mortality after Haemophilus influenzae serotype b (Hib). Given the success of the Hib vaccine program and the pathophysiologic similarities between Hib and Hia, immunization is the obvious way to protect Indigenous children living in small and scattered communities. The Public Health Agency of Canada has been working with the National Research Council and other members of the Consortium, including the Canadian Immunization Research Network, McGill Interdisciplinary Initiative in Infection and Immunity, GlycoNet, the Hewitt Foundation, and Inventprise/InventVacc, to develop a Hia vaccine for prevention of this deadly infection. The engagement process initiated by NRC with Consortium members and representatives from Indigenous groups, particularly, has led to the current project plan. In this first-in-human study, the investigators propose investigating the safety and immunogenicity of a novel glycoconjugate candidate vaccine that uses protein carrier CRM197 in healthy adults in the general population. The study will be conducted at the McGill University Health Center Vaccine Study Centre in Montreal and the Canadian Center for Vaccinology in Halifax. The findings of this Phase I study will be necessary to effectively move this potential vaccine solution further along the development continuum.

Research Team

Joanne M Langley, MD

Principal Investigator

Canadian Center for Vaccinology

Scott A. Halperin, MD

Principal Investigator

Canadian Center for Vaccinology

Brian Ward, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

This trial is for healthy adults in the general population. It's focused on preventing serious illness caused by Haemophilus influenzae serotype a (Hia), which has been affecting Indigenous children in Canada and Alaska.

Inclusion Criteria

To be enrolled, subjects must have a body mass index (BMI) ≤ 32 kg/m2

The subject is considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study

The subject must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; the subject must agree to complete study-related procedures and communicate with the study staff at visits and by phone during the study

Exclusion Criteria

I have not received any vaccines 30 days before or plan to within 30 days after the Hia vaccine.

History of anaphylactic allergic reactions to Hia Conjugate Vaccine components

I haven't taken antihistamines in the last 48 hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two doses of the Hia Conjugate Vaccine or placebo, 28 days apart

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with adverse events collected for 28 days post each dose and immunogenicity assessed at multiple time points

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Haemophilus Influenzae Serotype A Vaccine

Trial Overview The study tests the safety and ability to provoke an immune response of a new Hia glycoconjugate vaccine using protein carrier CRM197. This first-in-human study will take place at two Canadian research centers.

Participant Groups

Group I: Vaccine arm Active Control 1 Intervention

This arm receives 0.5 mL of a 10 µg dose of Hia Conjugate Vaccine with AdjuPhos.

Group II: Placebo arm Placebo Group 1 Intervention

This arm receives 0.5 mL placebo (normal saline).

Who Is Running the Clinical Trial?

InventVacc Biologicals Inc.

Lead Sponsor

Trials

1

Recruited

30+

Hia Consortium

Collaborator

Trials

1

Recruited

30+

Findings from Research

Among 28 children with congenital sensorineural hearing loss fitted with hearing aids, 18 also had a conductive component due to middle ear effusion or acute otitis media, which complicated the fitting process.

Children with both sensorineural and conductive hearing loss required significantly more fitting sessions and longer fitting periods, highlighting the need for early intervention and collaboration between audiologists and otolaryngologists to optimize hearing aid fitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Complexity of Hearing Aid Fitting: Children with Congenital Hearing Loss and Middle Ear Dysfunction. Priner, R., Brand, D.[2023]

The study involved 161 patients fitted with hearing aids, and it identified two key subscales in the International Outcome Inventory-Hearing Aids (IOI-HA): a 'benefit' subscale and a 'residual problems' subscale, which help measure the effectiveness of hearing aids.

The 'benefit' subscale correlated with improvements reported by patients on the Client-oriented Scale of Improvement (COSI), indicating that patients experienced significant benefits from their hearing aids, while the 'residual problems' subscale highlighted ongoing issues that some patients still faced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The International Outcome Inventory for Hearing Aids (IOI-HA) and its relationship to the Client-oriented Scale of Improvement (COSI). Stephens, D.[2019]

The International Outcome Inventory for Hearing Aids (IOI-HA) is a reliable seven-item questionnaire that effectively evaluates the effectiveness of hearing aid treatments across various research settings, ensuring comparability of data.

The original English version of the IOI-HA shows good internal consistency, suggesting that it can be summed to create a total outcome score, although generating two separate scores may enhance its reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The International Outcome Inventory for Hearing Aids (IOI-HA): psychometric properties of the English version. Cox, RM., Alexander, GC.[2022]

The Swedish translation of the International Outcome Inventory for Hearing Aids (IOI-HA) demonstrated reliable psychometric properties, similar to previous studies, based on a sample of 224 first-time hearing aid users.

The type of hearing loss significantly influenced the outcomes, with subjects having sensorineural hearing losses reporting poorer introspective scores compared to those with conductive or mixed hearing losses, indicating that the nature of hearing loss can affect the perceived effectiveness of hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing aid fitting outcome: clinical application and psychometric properties of a Swedish translation of the international outcome inventory for hearing aids (IOI-HA). Brännström, KJ., Wennerström, I.[2022]

Children with mild hearing loss who consistently used hearing aids showed significantly better vocabulary and grammar skills compared to those who did not use them, highlighting the importance of regular HA use for language development.

The study found that the amount of daily hearing aid use was a key predictor of improvements in language skills, suggesting that consistent use is crucial for maximizing auditory benefits in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Hearing Aid Use on Outcomes of Children With Mild Hearing Loss. Walker, EA., Holte, L., McCreery, RW., et al.[2022]

Vaccination of only newborns against Haemophilus influenzae serotype a (Hia) is insufficient to eliminate the pathogen, even with a booster program, highlighting the need for broader vaccination strategies.

To effectively eradicate Hia, it is crucial to vaccinate not just newborns but also susceptible individuals, along with maintaining high vaccination coverage and timely booster doses to sustain herd immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modelling the impact of vaccination on curtailing Haemophilus influenzae serotype 'a'. Konini, A., Moghadas, SM.[2015]

In a 5-year study of 35 patients with H. influenzae meningitis, 12 cases were identified as serotype a, highlighting a concerning rise in invasive disease due to this serotype, particularly in young children.

Despite 83% of the patients having received at least one dose of the Haemophilus influenzae type b vaccine, the study reported significant complications, including a 16.6% mortality rate due to severe outcomes like cerebral damage and shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemophilus influenzae Serotype a as a Cause of Meningitis in Children in Brazil. Russo, DO., Torres, BR., Romanelli, RMC., et al.[2023]

In a study of 133 children aged 3 months to 16 years, it was found that levels of antibodies (IgG and IgM) against Haemophilus influenzae type a (Hia) increased with age, indicating that older children have a stronger immune response to Hia.

The significantly higher concentrations of IgM compared to IgG suggest that natural exposure to environmental antigens may play a role in developing immunity, highlighting the need for immunization in younger children to prevent serious infections as Hia becomes more prevalent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seroprevalence of IgG and IgM antibodies to Haemophilus influenzae type a in Canadian children. Huska, B., Kubinec, C., Sadarangani, M., et al.[2022]

Since the introduction of Hib vaccines, the majority of invasive Haemophilus influenzae infections are now caused by non-Hib strains, particularly Hia, which poses significant health risks.

The similarities between the virulence factors of Hia and Hib suggest that a combined vaccine targeting both serotypes could effectively prevent serious diseases caused by these pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemophilus influenzae serotype a as a cause of serious invasive infections. Ulanova, M., Tsang, RSW.[2022]

Haemophilus influenzae serotype a (Hia) has become a significant pathogen in Canada following the success of vaccines against serotype b, with most cases belonging to clonal division I and the ST-23 clonal complex.

Surveillance for invasive H. influenzae disease should incorporate serotyping for Hia and multilocus sequence typing to identify hypervirulent clones, such as the ST-4 clone found in a recent Canadian isolate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population genetics of Haemophilus influenzae serotype a in three Canadian provinces. Tsang, RS., Shuel, M., Wylie, J., et al.[2020]

A study of 179 strains of Haemophilus influenzae isolated from 146 sick children in Argentina revealed a significant decrease in serotype b cases since the introduction of universal vaccination in 1998.

The research also noted a relative increase in other serotypes, indicating a shift in the serotype distribution of Hi infections following vaccination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Isolation of Haemophilus influenzae serotypes from deep sites in sick children]. Gatti, BM., Ramirez Gronda, GA., Etchevarría, M., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Complexity of Hearing Aid Fitting: Children with Congenital Hearing Loss and Middle Ear Dysfunction. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The International Outcome Inventory for Hearing Aids (IOI-HA) and its relationship to the Client-oriented Scale of Improvement (COSI). [2019]

3. England pubmed.ncbi.nlm.nih.gov

The International Outcome Inventory for Hearing Aids (IOI-HA): psychometric properties of the English version. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Hearing aid fitting outcome: clinical application and psychometric properties of a Swedish translation of the international outcome inventory for hearing aids (IOI-HA). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Influence of Hearing Aid Use on Outcomes of Children With Mild Hearing Loss. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Modelling the impact of vaccination on curtailing Haemophilus influenzae serotype 'a'. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Haemophilus influenzae Serotype a as a Cause of Meningitis in Children in Brazil. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Seroprevalence of IgG and IgM antibodies to Haemophilus influenzae type a in Canadian children. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Haemophilus influenzae serotype a as a cause of serious invasive infections. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Population genetics of Haemophilus influenzae serotype a in three Canadian provinces. [2020]

11. Argentina pubmed.ncbi.nlm.nih.gov

[Isolation of Haemophilus influenzae serotypes from deep sites in sick children]. [2020]