280 Participants NeededMy employer runs this trial

V132 Vaccine for Healthy Older Adults

Recruiting at 9 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and immune response of a new vaccine called V132 in healthy older adults. Researchers will compare different formulations of the V132 vaccine with existing vaccines to evaluate their effectiveness and the body's reaction. The trial consists of two parts: initially testing different doses and then expanding to include more participants. It suits healthy individuals who have not recently received certain pneumococcal vaccines or experienced related diseases. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Earlier research on the V132 vaccine has examined its safety and effects on the immune system in healthy older adults. These studies test different versions of V132. Since this research is in the early stages, it primarily observes immediate reactions and any side effects, especially near the injection site.

For CAPVAXIVE and PREVNAR 20, more safety information is available. Extensive studies have shown these vaccines are generally well-tolerated. Most side effects, if they occur, are mild and may include a sore arm or a slight fever.

As the current study begins, its main goal is to ensure the treatment's safety for participants. Serious side effects are unlikely, but researchers carefully monitor to confirm this. Overall, the focus remains on ensuring these vaccines are safe for older adults.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the V132 vaccine formulations because they offer a new approach to protecting healthy older adults from infectious diseases. Unlike standard vaccines like PREVNAR 20™, which target specific pathogens, the V132 formulations are being tested for their potential to provide broader immune responses. This could mean more comprehensive protection and possibly a longer-lasting immunity, which is particularly important for older adults whose immune systems may not respond as robustly to traditional vaccines. By exploring different formulations in the trial, researchers aim to identify the most effective dose to maximize these benefits.

What evidence suggests that this trial's treatments could be effective?

Research has shown that the V132 vaccine is under development to protect older adults from pneumococcal disease. This trial will evaluate different formulations of the V132 vaccine. Existing vaccines like PCV13 have effectively reduced serious cases of this disease in older adults. Studies suggest that newer vaccines, such as CAPVAXIVE and PREVNAR 20, also lower the risk of pneumonia in older adults. These vaccines have proven safe and effective, supporting the potential success of the V132 vaccine formulations tested in this trial.678910

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy older adults with a BMI between 18.0 and 35.0 who do not have any major health issues.

Inclusion Criteria

Is in good health
Has body mass index (BMI) within 18.0 to 35.0 kg/m^2 inclusive

Exclusion Criteria

I have had a serious pneumococcal infection in the past 3 years.
I have had a pneumococcal vaccine in the last 10 years.
I have received a pneumococcal conjugate vaccine before joining this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive single intramuscular doses of a V132 formulation or comparator regimen at varying dose levels

1 day
1 visit (in-person)

Dose Expansion

Participants receive single intramuscular doses of a V132 formulation or comparator regimen based on Part 1 data

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • CAPVAXIVE™
  • PREVNAR 20™
  • V132 Formulation 1
  • V132 Formulation 2
  • V132 Formulation 3

Trial Overview

The study is testing different versions of the V132 vaccine compared to existing vaccines (PREVNAR 20™ and CAPVAXIVE™) to see how safe they are and how well they trigger an immune response in older adults.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment5 Interventions
Group II: Part 1: Dose EscalationExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

Learn More: Pneumococcal Vaccines for Older Adults

You can protect yourself against pneumonia and its health dangers. Pneumococcal vaccines can help you avoid getting sick. Pneumococcal bacteria are a common ...

PCV20 Associated With Reduced Pneumonia Risk in Older ...

Vaccine effectiveness was generally highest among adults aged 65 to 74 years and lowest among adults aged 85 years and older.

Higher-Valent Pneumococcal Conjugate Vaccines More Cost

Higher-valent pneumococcal conjugate vaccines (PCVs), especially PCV20, show greater cost-effectiveness over lower-valent vaccines and ...

CDC Recommendations for CAPVAXIVE® (Pneumococcal ...

CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). The safety and effectiveness of CAPVAXIVE in individuals younger than 2 ...

PCV20 Associated With Reduced Pneumonia Risk in Older ...

Vaccine effectiveness was generally highest among adults aged 65 to 74 years and lowest among adults aged 85 years and older.

6.

vaccinesafety.edu

vaccinesafety.edu/

Institute for Vaccine Safety – Information on vaccine safety

The Institute for Vaccine Safety independently assesses vaccines and vaccine safety to guide decision making at the policy, practice, and individual level.

Vaccines & Immunizations

Vaccine Basics · Vaccines and the Diseases they Prevent · Vaccines by Age · VaxView Vaccination Coverage · Glossary · Vaccine Schedules For You and Your Family ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36055877/

Serious adverse events of special interest following mRNA ...

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 ...

vaccine schedule from the American Academy of Pediatrics

No information is available for this page.

Vaccine

Vaccinations given to children, adolescents, or adults are generally safe. se effects, if any, are generally mild. Some common side effects include fever, pain ...