What side effects are associated with this type of intervention?

Common side effects of pneumococcal conjugate vaccines, including those similar to the 21-valent pneumococcal conjugate vaccine (V116), typically involve local reactions at the injection site (pain, redness, and swelling), fever, irritability, and fatigue. Serious adverse events are rare but can include allergic reactions.

What prior FDA approvals exist?

The FDA has approved several pneumococcal conjugate vaccines (PCVs) for the treatment of Pneumococcal Disease. These include the 7-valent pneumococcal conjugate vaccine (PCV7), which was licensed in 2000, followed by the 13-valent pneumococcal conjugate vaccine (PCV13). More recently, the 15-valent (PCV15) and 20-valent (PCV20) pneumococcal conjugate vaccines have been approved. These vaccines work by stimulating the immune system to produce antibodies that enhance opsonophagocytic activity, thereby providing protection against various serotypes of Streptococcus pneumoniae.

What other types of research exist?

Promising alternatives to the Pneumococcal 21 Valent Conjugate Vaccine (V116) include the 15-valent pneumococcal conjugate vaccine (PCV15) and the 20-valent pneumococcal conjugate vaccine (PCV20). Both vaccines have demonstrated strong immunogenicity and safety profiles in recent studies, making them viable options for pneumococcal disease patients in 2024.

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Vaccine

V116 Vaccine for Pneumococcal Disease (STRIDE-8 Trial)

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has documented result(s) of ≥1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with ≥1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements ≤9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (>3 months duration).

Be between 18 and 65 years old

Must not have

Has a history of active hepatitis.

Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 6

Awards & highlights

Summary

This trial is testing a new vaccine (V116) that protects against 21 types of bacteria causing pneumonia. It targets adults at risk of these infections and works by training the immune system to fight these bacteria.

Who is the study for?

Adults at high risk for pneumococcal disease, stable on current treatments with conditions like diabetes (with controlled HbA1c), chronic liver disease, COPD, asthma, heart or kidney disease. Must not be pregnant or planning to get pregnant and agree to use contraception if of childbearing potential. Excludes those with recent severe infections, hypersensitivity to vaccine components, bleeding disorders preventing shots, active cancer treatment within 3 years, planned major surgery or organ transplant during the study.

What is being tested?

The trial is testing a new vaccine called V116 against pneumococcal diseases compared to an existing vaccine regimen including PCV15 and PPSV23. It aims to assess safety and immune response by measuring how well the body can fight off the bacteria after vaccination.

What are the potential side effects?

Possible side effects include reactions at the injection site such as pain and swelling, feverish symptoms similar to mild flu-like illness. There may also be allergic reactions in rare cases due to sensitivity towards any component of the vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a condition like diabetes, liver disease, COPD, asthma, heart or kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had active hepatitis in the past.

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I have had diabetic ketoacidosis or two severe low blood sugar episodes recently.

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I have not had a heart attack or stroke in the last 3 months.

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I have severe lung blood pressure or Eisenmenger syndrome.

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I have a history of chronic kidney issues or autoimmune kidney disease.

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I had a serious lung infection confirmed by a lab test in the last 3 years.

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I have a blood clotting disorder that prevents me from getting shots in my muscles.

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I am scheduled for a major organ transplant or surgery during this study.

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I have had or will have a pneumococcal vaccine outside this study's protocol.

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I am currently on medication that affects my immune system.

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I haven't had a live virus vaccine in the last 30 days and won't have one for 30 days after getting the study vaccine.

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I use oxygen at home regularly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination

Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination

Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study

+1 more

Secondary study objectives

Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses

Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination

Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: V116Experimental Treatment2 Interventions

Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo for PCV15 + PPSV23 on Week 8

Group II: PCV15 + PPSV23Active Control2 Interventions

Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

V116

2022

Completed Phase 3

~8610

Placebo for PCV15 + PPSV23

2023

Completed Phase 3

~520

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pneumococcal Disease involve the use of pneumococcal conjugate vaccines (e.g., PCV13, PCV15, and the investigational V116). These vaccines work by stimulating the immune system to produce specific antibodies that enhance opsonophagocytic activity, a process where antibodies mark the bacteria for destruction by immune cells. This mechanism is vital for Pneumococcal Disease patients as it helps prevent severe infections by enabling the immune system to recognize and eliminate the bacteria more effectively, thereby reducing morbidity and mortality associated with the disease.

Pneumococcal immunization in immunocompromised hosts: where do we stand?