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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to involve more men in preventive healthcare by offering vaccines and health education at birthing centers. Researchers aim to determine if providing vaccines at the bedside, along with information or personal support, increases vaccine uptake and overall health engagement among men. This approach is part of the Enhanced Cocoon Vaccination Strategy. The study includes three groups: one receives vaccine offers only, another receives a flyer with the vaccine offer, and the last group receives both a flyer and personalized healthcare support. Men visiting a birthing center who identify as male are well-suited for this trial. As an unphased trial, this study presents a unique opportunity to contribute to innovative strategies for improving men's health engagement.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the vaccines used in the Enhanced Cocoon Vaccination Strategy are generally safe. For instance, one study found that 84% of people believed the flu vaccine was safe. The Tdap vaccine, which protects against whooping cough, is also widely used and has a strong safety record in similar situations.

In another study, when family members of newborns received free flu vaccines, 54.9% chose to get vaccinated, indicating comfort with the vaccines. These findings suggest that the vaccines in this strategy are well-tolerated.

For those considering joining a trial offering these vaccines, past research supports their safety. Participants should feel free to ask the trial team any questions about possible side effects or other concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve vaccination rates among male-identifying visitors in birthing centers. Unlike standard vaccination methods, which often rely on individuals seeking out vaccines themselves, this trial offers bedside vaccinations, making it incredibly convenient. Additionally, one arm of the trial provides a "high-touch" connection, guiding participants to healthcare navigation support, which could help improve overall health literacy and access to preventive care. By actively providing information and support directly at the birthing center, the trial aims to enhance the uptake of crucial vaccines like influenza and Tdap, ultimately leading to better community health outcomes.

What evidence suggests that this trial's treatments could be effective in increasing men's engagement in preventive healthcare?

Research shows that the cocoon vaccination strategy can protect babies by vaccinating those around them, such as family members and close friends. Studies have found that this approach significantly reduces the risk of flu and other serious respiratory infections in babies when their family members receive vaccinations. In this trial, male-identifying visitors in the birthing center will participate in different treatment arms. One arm will offer bedside vaccines plus information, another will provide bedside vaccines with a high-touch connection to healthcare navigation supports, and a third will offer vaccination only. Evidence suggests that when men receive both vaccines and health information, they are more likely to use health services. Overall, the cocoon strategy aims to increase vaccine uptake and improve health habits by making vaccines accessible and providing useful health information. ^{1 2 6 7 8}

Who Is on the Research Team?

Randy Vince, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11093031/

Effectiveness of cocoon strategy vaccination on prevention ... This study provides clear evidence that influenza vaccination of all household contacts of infants aged 0–6 months is significantly associated with protecting ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06437834

Increasing Men's Engagement in Preventive Healthcare ... This pilot study will examine whether implementing a cocoon vaccination strategy that provides access to vaccinations and overall health education for men leads ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196655312010218

Free vaccine programs to cocoon high-risk infants and ... An adult immunization strategy called “cocooning” is a relatively new concept, referring to immunizing close contacts of infants and high-risk children, ...

4. intechopen.com intechopen.com/chapters/55384

Cocoon Strategy of Vaccinations: Benefits and Limitations A cocoon vaccination strategy refers to vaccinations in persons from the immediate environment of those patients who might develop an illness.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38738691/

Effectiveness of cocoon strategy vaccination on prevention ... Among the infants with only the mother vaccinated, the effectiveness of influenza vaccine is estimated as 35.3% for ILI and 41.3% for SARI.

6. academic.oup.com academic.oup.com/cid/article/52/2/157/373472

Implementation of Cocooning against Pertussis in a High-Risk ... Our finding that the Tdap vaccine uptake rate among postpartum women increased during the 2009 H1N1 influenza pandemic, probably attributable in part to greater ...

7. mdpi.com mdpi.com/2076-393X/11/7/1235

The Degree of Acceptance of Cocoon Strategy ... Respondents regarded influenza vaccination as safe (84%) and effective (76 ... The source of information on vaccine safety varied depending on sex and education ...

8. researchgate.net researchgate.net/publication/319627618_Cocoon_Strategy_of_Vaccinations_Benefits_and_Limitations

Cocoon Strategy of Vaccinations: Benefits and Limitations Creating a protective cocoon by immunizing caregivers in the family is an intuitive strategy to protect tiny babies from vaccine-preventable diseases (VPD) [1] ...