What side effects are associated with this type of intervention?

The most common treatments for pneumococcal diseases include pneumococcal conjugate vaccines (PCV) and pneumococcal polysaccharide vaccines (PPSV). Known side effects of these vaccines are generally mild and include pain, redness, and swelling at the injection site, as well as fever and muscle aches. Serious adverse events are rare but can include severe allergic reactions. In clinical trials, the safety profiles of PCV13, PCV15, and PCV20 were similar, with most side effects being transient and resolving within a few days.

What prior FDA approvals exist?

The FDA has approved several pneumococcal vaccines aimed at preventing pneumococcal diseases by stimulating the immune system. Notable vaccines include the 13-valent pneumococcal conjugate vaccine (PCV13), the 15-valent pneumococcal conjugate vaccine (PCV15), and the 23-valent pneumococcal polysaccharide vaccine (PPSV23). These vaccines are designed to protect against multiple serotypes of Streptococcus pneumoniae, the bacterium responsible for pneumococcal diseases. PCV13 and PCV15 are conjugate vaccines that are particularly effective in young children and immunocompromised individuals, while PPSV23 is used in older children and adults to provide broader protection against additional serotypes.

What other types of research exist?

Promising novel alternatives to current pneumococcal vaccines for 2024 include the new pneumococcal vaccine candidates being studied in the referenced clinical trial. These candidates are being compared to the 20-valent pneumococcal conjugate vaccine (Prevnar 20) and are administered as a single shot into the upper arm muscle. The study aims to determine the safety and immune response of these new formulations in adults. Additionally, the 15-valent pneumococcal conjugate vaccine (V114) has shown safety and immunogenicity in various populations, including adults living with HIV, and may be a viable alternative.

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Cancer Vaccine

Pneumococcal Vaccine for Pneumococcal Disease

Phase 1 & 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)

Be older than 18 years old

Must not have

Known or suspected immunodeficiency or other conditions associated with immunosuppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different versions of a pneumococcal vaccine to see if they are safe and effective. It involves adults aged 18-49 in the initial phase and adults aged 50 and older in the later phase. The vaccine helps the immune system fight off pneumococcal bacteria. A newer version of the vaccine is designed to protect against 20 different types of bacteria.

Who is the study for?

This trial is for healthy adults to test a new pneumococcal vaccine. Stage 1 includes those aged 18-49, while Stage 2 includes individuals 50 and older. Participants must be willing to give blood samples and report any side effects during clinic visits over a period of up to one year.

What is being tested?

The study tests two different formulations of a new pneumococcal vaccine against an existing vaccine (20vPnC, Prevnar 20). Each participant receives one shot in the upper arm muscle and is monitored for immune response and safety.

What are the potential side effects?

Potential side effects from the vaccines may include pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, chills or fever. These are common reactions similar to other vaccines.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18-49 years old and have never received a pneumococcal vaccine.

Exclusion Criteria

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

Select...

I have a condition that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination

Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination

Percentage of participants reporting prespecified local reactions within 7 days after vaccination

+2 more

Secondary study objectives

Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2Experimental Treatment1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2).

Group II: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1Experimental Treatment1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2).

Group III: Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)Active Control1 Intervention

Participants to receive a single injection of 20vPnC.

0 / 2Eligibility 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

Pneumococcal vaccines work by stimulating the immune system to recognize and fight Streptococcus pneumoniae bacteria, which cause pneumococcal diseases. These vaccines contain inactivated components of the bacteria, which trigger an immune response involving the production of antibodies. This immune response provides long-term protection against severe infections such as pneumonia, meningitis, and bacteremia, reducing morbidity and mortality associated with these diseases.