Enhanced Vaccination Strategy for Preventive Medicine

Overseen By Sarah Koopman Gonzalez, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Randy Vince, MD

Disqualifiers: Under 18, Not male-identifying

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

450 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Enhanced Cocoon Vaccination Strategy treatment?

The cocoon vaccination strategy, which involves vaccinating those in close contact with vulnerable patients, has been shown to protect high-risk groups like infants, children, and oncological patients from diseases such as influenza and pertussis. This suggests that the Enhanced Cocoon Vaccination Strategy could be effective in preventing infections by reducing exposure to pathogens. ^{1 2 3 4 5}

Is the Enhanced Vaccination Strategy generally safe for humans?

Vaccine safety monitoring systems, like those implemented in Vietnam, Zimbabwe, and Ghana, help track adverse events following immunization, ensuring vaccines are safe for humans. These systems are crucial for identifying and addressing any safety concerns, providing confidence in the safety of vaccination programs. ^{6 7 8 9 10}

How does the Enhanced Vaccination Strategy differ from other treatments for this condition?

The Enhanced Vaccination Strategy is unique because it focuses on a 'cocooning' approach, which involves vaccinating those in close contact with high-risk individuals to protect them from infectious diseases. This strategy is different from traditional vaccination methods that directly target the at-risk individuals themselves. ^{3 4 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to understand if offering a high touch engagement with healthcare center catered to men and bedside vaccine access in a birthing center increases men's engagement in preventive healthcare. The main questions it aims to answer are: Does access to vaccinations and overall health education for men lead to increased uptake of vaccines? Does access to vaccinations and overall health education for men lead to increased engagement in overall healthcare of male identifying support persons. Researchers will compare three arms (one that receives an offer of vaccines at bedside in the birthing clinic, one that receives an information flyer about the importance of preventive care in addition to the offer of vaccines and a third one that receives higher level of engagement from patient liaisons as well as the offer of vaccines at bedside) to see if there is a difference in vaccine uptake and engagement in healthcare Participants will complete two survey and one interview.

Research Team

Randy Vince, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for male-identifying partners of birthing individuals at a birthing center. It aims to see if certain strategies increase their involvement in preventive healthcare, like getting vaccines and engaging with health services.

Inclusion Criteria

I am a male-identifying partner of someone giving birth at a birthing center.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive bedside vaccinations and healthcare engagement interventions

18 weeks

Weekly visits for vaccination and engagement activities

Follow-up

Participants are monitored for vaccine uptake and healthcare engagement

4 weeks

1 survey and 1 interview

Treatment Details

Interventions

• Enhanced Cocoon Vaccination Strategy

Trial Overview The study tests three approaches: one group gets vaccine offers at the bedside, another also receives an info flyer on preventive care, and the third experiences more engagement from patient liaisons plus bedside vaccine offers.

Participant Groups

Group I: Offer of Bedside Vaccines plus Information Experimental Treatment 1 Intervention

All male-identifying visitors in the birthing center at the birthing center will receive an information sheet about vaccinations and preventive healthcare, and will be offered influenza and Tdap vaccinations at bedside in the birthing center.

Group II: Offer of Bedside Vaccines plus High-touch connection Experimental Treatment 2 Interventions

All male-identifying visitors in the birthing center will receive the information sheet, and will be offered influenza and Tdap vaccinations at bedside in the birthing center, as well as a high-touch connection to healthcare navigation supports.

Group III: Vaccination Offer only Active Control 1 Intervention

all male-identifying visitors in the birthing center will receive the offer of influenza and Tdap vaccinations at the bedside only.

Who Is Running the Clinical Trial?

Randy Vince, MD

Lead Sponsor

Trials

1

Recruited

450+

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Findings from Research

In a study of 98 oncological patients, only 43.9% were vaccinated against influenza, which is lower than the vaccination rates in the general population over 60 years old, indicating a potential gap in protection for these vulnerable patients.

Many unvaccinated patients and their household contacts cited misconceptions about the necessity and safety of the vaccine, highlighting the need for better education and awareness regarding the benefits of cocoon vaccination to protect oncological patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cocoon vaccination for influenza in patients with a solid tumor: a retrospective study. Rensink, MJ., van Laarhoven, HWM., Holleman, F.[2022]

The Easy Vaccination in Oncology (EVO) strategy significantly increased vaccination rates among oncological patients, with notable improvements of 21.5% for Streptococcus pneumoniae and 12.2% for influenza after 3 months.

The intervention demonstrated a strong effect, with an odds ratio of 7.50, indicating that the EVO approach is effective in enhancing vaccination uptake in this at-risk population, potentially protecting them from preventable infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled non-randomised before-after study evaluating the impact of a focused recommendation card on vaccination rates of oncological patients-The Easy Vaccination in Oncology (EVO) strategy. Kiderlen, TR., Trostdorf, K., Delmastro, N., et al.[2022]

Only 40% of children living with patients who have inflammatory bowel disease (IBD) were vaccinated with at least one recommended vaccine, indicating a significant gap in the cocoon strategy intended to protect vulnerable patients.

The most common reason for vaccine refusal among patients was the belief that immunizations were unnecessary, highlighting the need for better education and promotion of vaccination, especially for nonmandatory vaccines like pneumococcal and varicella.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 'cocoon immunization strategy' among patients with inflammatory bowel disease. Waszczuk, K., Waszczuk, E., Mulak, A., et al.[2018]

The 'cocooning' strategy aims to protect infants and high-risk children by vaccinating their close contacts, thereby reducing their exposure to pathogens.

The report discusses the implementation of free vaccine programs in US children's hospitals, highlighting the positive experiences of institutions in adopting this strategy to enhance community immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free vaccine programs to cocoon high-risk infants and children against influenza and pertussis. Guzman-Cottrill, JA., Phillipi, CA., Dolan, SA., et al.[2012]

The 4 Pillars Practice Transformation Program was implemented in a randomized controlled trial involving 18,107 adults aged 65 and older, resulting in significant increases in pneumococcal vaccination rates across all groups, with increases of 6.5 to 8.7 percentage points in Year 1.

In Year 2, practices actively using the 4 Pillars Program showed a significantly higher likelihood of administering pneumococcal vaccines compared to those in the maintenance phase, particularly in Pittsburgh, indicating the program's effectiveness in enhancing vaccination uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the 4 Pillars Practice Transformation Program to Increase Pneumococcal Immunizations for Older Adults: A Cluster-Randomized Trial. Zimmerman, RK., Brown, AE., Pavlik, VN., et al.[2018]

Vaccine safety assessment goes beyond just monitoring adverse events; it requires a comprehensive approach that includes manufacturing control, long-term effect surveillance, and post-marketing data analysis.

To ensure a balanced risk-to-benefit evaluation for new vaccines, it is crucial to involve a central safety department throughout the clinical development and post-marketing phases, emphasizing the importance of standardized safety monitoring procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring and safety assessment in Phase I to III clinical trials. Fescharek, R., Nicolay, U., Arras-Reiter, C.[2007]

Vaccination programs are crucial for preventing illness and death in developing countries, but their success is jeopardized by rumors and misunderstandings about vaccine safety.

Establishing effective vaccine safety monitoring systems, like the one implemented in Vietnam, is essential for tracking adverse events and maintaining public confidence in vaccination programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model. Ali, M., Rath, B., Thiem, VD.[2019]

A total of 272 vaccine-related adverse event reports were analyzed from Zimbabwe, with the majority linked to measles and OPV/DTP-Hib-HepB vaccines, indicating a need for ongoing monitoring of these vaccines' safety.

The study revealed that systemic events were more common with measles vaccines, while local reactions were more frequently associated with OPV/DTP-Hib-HepB, highlighting specific safety concerns that could inform future vaccination strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase® from 1997 to 2017. Masuka, JT., Khoza, S.[2020]

A total of 5,141 adverse event reports were analyzed from six different vaccines in Ghana, with a significant number of events (22% to 55%) occurring on the day of vaccination and 87% within the first week post-vaccination.

The measles-rubella vaccine had the highest reported adverse event rate for urticarial, while abdominal pain was the most notable adverse event for both the human papilloma and measles-rubella vaccines, indicating specific safety signals that public health systems can monitor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events following immunizations in Ghana - Using disproportionality analysis reporting ratios. Ankrah, DNA., Darko, DM., Sabblah, G., et al.[2019]

The study found that the BNT162b2, CoronaVac, and ChAdOx1 COVID-19 vaccines generally have acceptable safety profiles, with no increased risk for serious conditions like myocarditis, stroke, or myocardial infarction within 21 days post-vaccination.

However, a small increased risk was noted for venous thromboembolism, arrhythmia, and convulsions/seizures in BNT162b2 recipients, while ChAdOx1 was associated with a higher risk of thrombocytopenia and venous thromboembolism, indicating the need for ongoing safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study. Ab Rahman, N., Lim, MT., Lee, FY., et al.[2022]

The WHO's 1976 vaccination strategy aims to immunize all children globally against six major infectious diseases, highlighting the importance of vaccination in controlling communicable diseases.

Recent advancements in vaccine development, including new bacterial vaccines and innovative production methods, are crucial for preventing nosocomial infections and protecting vulnerable patients, emphasizing the ongoing evolution of vaccination strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Modern bacterial vaccines]. Mebel, S., Thilo, W.[2006]

Despite the success of vaccines in improving human health, there is still a need for new vaccines to combat emerging diseases and address safety concerns with existing vaccine types.

Recent advancements in delivery technologies and immunology have provided new strategies for vaccine development, including the use of innovative systems like the 'E2 scaffold' from Geobacillus stearothermophilus, which may enhance immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel antigen delivery systems. Trovato, M., De Berardinis, P.[2020]

Vaccinology aims to enhance existing vaccines and create new ones, focusing on safety, efficacy, and immunogenicity, particularly for diseases like flu, tuberculosis, cholera, and rabies.

The field is also working towards optimizing vaccination programs by developing combination vaccines to protect against multiple diseases with fewer shots, exemplified by the goal of creating a hexavalent vaccine by the year 2000.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vaccination perspectives]. Saliou, P., Plotkin, S.[2006]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Cocoon vaccination for influenza in patients with a solid tumor: a retrospective study. [2022]

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

Controlled non-randomised before-after study evaluating the impact of a focused recommendation card on vaccination rates of oncological patients-The Easy Vaccination in Oncology (EVO) strategy. [2022]

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

A 'cocoon immunization strategy' among patients with inflammatory bowel disease. [2018]

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

Free vaccine programs to cocoon high-risk infants and children against influenza and pertussis. [2012]

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

Using the 4 Pillars Practice Transformation Program to Increase Pneumococcal Immunizations for Older Adults: A Cluster-Randomized Trial. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Monitoring and safety assessment in Phase I to III clinical trials. [2007]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase® from 1997 to 2017. [2020]

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

Reporting of adverse events following immunizations in Ghana - Using disproportionality analysis reporting ratios. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Modern bacterial vaccines]. [2006]

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

Novel antigen delivery systems. [2020]

13. France pubmed.ncbi.nlm.nih.gov

[Vaccination perspectives]. [2006]