VAXNEUVANCE 15 Pneumococcal Vaccine

U.S. FDA Accepts for Priority Review the Biologics License Application for Investigational 15-valent Pneumococcal Vaccine

Don Hackett — Tue, 12 Jan 2021 18:11:27 +0000

Reviewer:

The U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older.

Merck announced the FDA set a Prescription Drug User Fee Act, or target action date, of July 18, 2021.

Furthermore, Merck stated the European Medicines Agency is also reviewing an application for licensure of V114 in adults. Merck is also developing V114 for use in children.

“Invasive pneumococcal disease in adults is on the rise in many countries, driven by highly-invasive serotypes including serotype 3, which is included in the currently licensed pneumococcal conjugate vaccine, as well as serotypes not included, such as serotypes 22F and 33F,” said Dr. Roy Baynes, SVP and head of global clinical development, CMO, Merck Research Laboratories, in a press release issued on January 12, 2021.

“We look forward to working with the FDA during the review of this application.”

V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease in adults. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease in older adults worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults.

V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.

The BLA and priority review designation is supported by results from Phase 2 and Phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.

Additional studies in the BLA support the potential use of V114 in various real-world clinical settings, including in co-administration with the quadrivalent influenza vaccine and as part of a sequential administration with PNEUMOVAX 23, and demonstrate equivalent performance among consecutive lots of V114.

The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition.

Visit Merck.com to learn more about Merck’s infectious diseases pipeline.

PrecisionVaccinations publishes research-based vaccine news.

Sub Title:

Merck investigational 15-valent pneumococcal conjugate vaccine prevents disease

References:

U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal

Pneumovax 23 Pneumococcal Vaccine

V114 Pneumococcal Disease Vaccine

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15-Valent Pneumococcal Conjugate Vaccine Reports Positive Phase 3 Results

Don Hackett — Tue, 20 Oct 2020 21:25:07 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

Two additional Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, a Merck investigational 15-valent pneumococcal conjugate vaccine were announced.

Merck’s press release on October 20, 2020, stated ‘V114 was generally well-tolerated in both studies, with a safety profile consistent with that observed for V114 in previously reported studies.’

V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine in development for the prevention of pneumococcal disease in adults and children. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with the invasive pneumococcal disease worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults.

Dr. Roy Baynes, senior VP and head of global clinical development, CMO, Merck Research Laboratories, stated: “These data provide important information about the potential for V114 followed by PNEUMOVAX 23, a polysaccharide vaccine included in more than 90 percent of age-based adult pneumococcal immunization programs globally, to help protect healthy adults and adults who are at increased risk for pneumococcal disease.”

In the PNEU-PATH (V114-016) study, healthy adults 50 years of age or older received V114 or PCV13, followed by PNEUMOVAX® 23, one year later. This study found the immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114.

Results also showed that at 30 days post-vaccination with either V114 or PCV13, immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F, the two serotypes not included in PCV13.

In the PNEU-DAY (V114-017) Phase 3 study, immunocompetent adults 18 to 49 years of age with underlying medical conditions associated with increased risk for pneumococcal disease, V114 generated immune responses generally comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days post-vaccination.

These findings from the V114 Phase 3 clinical program in adults, including PNEU-PATH and PNEU-DAY, will be presented at a future scientific congress. Plans for global regulatory licensure applications, beginning with the U.S. Food and Drug Administration (FDA) before the end of 2020, remain on track.

Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S., among adults 65 years of age or older.

Invasive pneumococcal disease due to serotypes 22F and 33F has been linked to higher case fatality rates and prolonged hospitalization in adults. Overall, adults with certain medical conditions, such as heart disease, diabetes, or chronic obstructive pulmonary disease (COPD), have a higher risk for pneumococcal disease compared to those without these conditions.

The V114 Phase 3 clinical development program is comprised of 16 trials investigating the safety, tolerability, and immunogenicity of V114 in a variety of populations who are at increased risk for pneumococcal disease, including healthy older adults and children, as well as people who are immunocompromised or have certain chronic medical conditions.

About Pneumococcal Disease

The global prevalence of pneumococcal disease, an infection caused by bacteria called Streptococcus pneumoniae, is evolving. There are more than 90 different types of pneumococcal bacteria which can affect adults differently than children.

Highly aggressive strains, or serotypes, threaten to put more people at risk for non-invasive pneumococcal illnesses such as pneumococcal pneumonia, sinusitis, and otitis media, and invasive pneumococcal illnesses such as pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord).

While healthy adults and children can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include children under the age of 2, older adults such as those 65 years of age and older, and people with immunosuppressive or certain chronic health conditions.

An updated overview of pneumococcal vaccines is listed on this PrecisionVaccinations webpage.

PrecisionVaccinations publishes research-based vaccine development news.

Sub Title:

Merck V114 pneumococcal conjugate vaccine consists of 15 serotypes

References:

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-v

V114 Pneumococcal Disease Vaccine

Pneumococcal Vaccines

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15-valent Pneumococcal Conjugate Vaccine Reports Very Positive Phase 2 Results

Don Hackett — Wed, 08 May 2019 14:14:55 +0000

Reviewer:

Kelley Lu, PharmD

Robert Carlson, MD

Danielle Reiter, RN

A Phase 2 clinical trial evaluating the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine candidate V114 reported very positive results.

This is important news since it is estimated that about 900,000 Americans get pneumococcal pneumonia each year.

In this study, NCT02982972, V114 was reported by Merck to have met its primary endpoint by demonstrating noninferiority for the 13 serotypes.

Additionally, V114 also induced an immune response in infants for 2 additional disease-causing serotypes, 22F and 33F, which are not contained in PCV13.

This Phase 2 study V114-008, was a double-blind, randomized trial, comparing the safety, tolerability, and immunogenicity of 2 different clinical lots of V114, in approximately 1,050 healthy infants at 2, 4, 6 and 12-15 months of age.

In the study, the percentage of subjects who achieved the accepted threshold of an immune response (IgG≥0.35 mcg/mL) with either lot of V114 was non-inferior to the percentage seen with PCV13, for the 13 serotypes shared between the 2 vaccines.

For serotype 3, the percentage of subjects who achieved this threshold of the immune response was higher for V114 (96.0% for lot 1; 94.1% for lot 2) compared with PCV13 (71.8%).

For the 2 serotypes not included in PCV13, serotype 22F and serotype 33F, the percentage of subjects who achieved the defined threshold of immune response with V114 was above 98 percent and above 87 percent, respectively.

These results were consistent between the two lots of V114 studied, and the safety profiles were evaluated after each dose and throughout the study.

“Children under the age of 2 are at increased risk for pneumococcal infection, which in some cases may lead to serious illnesses like pneumococcal pneumonia,” said Dr. David Greenberg, study investigator, and physician in the Pediatric Infectious Disease Unit of Soroka University Medical Center in Beer-Sheva, Israel.

“These Phase 2 data evaluating V114 in infants are encouraging and mark important progress to helping expand protection against pneumococcal disease for this vulnerable patient population.”

Pneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae, and includes non-invasive illnesses such as pneumonia, sinusitis, and otitis media, and invasive illnesses such as bacteremia, bacteremic pneumonia, and meningitis, says the Centers for Disease Control and Prevention (CDC).

Currently, healthcare professionals use 2 different vaccines to prevent pneumococcal disease, says the CDC.

The pneumococcal conjugate vaccine (PCV13) is given to children in the first 2 years of life, to all adults 65 years or older, and to older children and younger adults with certain conditions that weaken their immune system.

Healthcare professionals give the pneumococcal polysaccharide vaccine (PPSV23) to adults 65 years or older, as well as children 2 years or older and younger adults with certain conditions that put them at increased risk.

Results of the V114-008 study were presented during an oral session at the 37th Annual Meeting of the European Society for Paediatric Infectious Diseases.

Merck has a broad clinical development program for V114 currently comprised of 11 Phase 3 clinical trials. These studies are investigating V114 in adults (NCT03480763, NCT03615482), in the pediatric population (NCT03692871, NCT03620162, NCT03885934, NCT03893448), and in immunocompromised persons and those at increased risk for invasive pneumococcal disease (NCT03547167, NCT03921424, NCT03731182, NCT03480802, NCT03565900).

Click here to learn more about Merck’s infectious diseases pipeline.

Sub Title:

Merck V114 is a 15-valent pneumococcal conjugate vaccine candidate for the prevention of pneumococcal disease

References:

Merck Announces Results from Phase 2 Trial of Investigational 15-valent Pneumococcal Conjugate Vaccine (V114) in Infants

Pneumococcal Disease: Fast Facts

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15-Valent Pneumococcal Conjugate Vaccine Granted Breakthrough Status

Don Hackett — Wed, 30 Jan 2019 20:26:30 +0000

Reviewer:

Kelley Lu, PharmD

Robert Carlson, MD

Danielle Reiter, RN

Merck’s investigational 15-valent pneumococcal conjugate vaccine V114 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age.

To qualify for this FDA designation, preliminary clinical evidence must demonstrate that the drug may provide a substantial improvement over currently available therapy on at least one clinically significant endpoint.

V114 is also under development for the prevention of IPD in adults. Both indications are currently being studied in Phase 3 clinical trials.

This is important news since the World Health Organization estimates that S. pneumoniae kills close to 500,000 children under 5 years old worldwide every year, with most of these deaths occurring in developing countries.

The FDA’s decision was informed in part by immunogenicity data from 2 studies, which are as follows:

Study 005 was a Phase 1/2, multicentre, randomized, double-blind study to evaluate the safety, tolerability and immunogenicity profiles of 4 different lots of a new formulation of V114 in healthy adults and infants.
Study 008 was a proof of concept, Phase 2, pediatric trial to confirm the results from Study 005 in a larger population of infants.

In both studies, V114 induced an immune response in infants for 2 disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine, while demonstrating non-inferiority for the serotypes contained in both vaccines.

Invasive pneumococcal disease is a notable cause of morbidity and mortality in the US, despite the availability of 7-valent pneumococcal conjugate vaccine (PCV7) and 13-valent pneumococcal conjugate vaccine (PCV13), says the Centers for Disease Control and Prevention (CDC).

Dr. Nicholas Kartsonis, senior vice president and head of vaccine and infectious diseases clinical research at Merck Research Laboratories, said in a press release, “The goal of our program in pediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine.”

Streptococcus pneumoniae, or pneumococcus, is a type of bacterium that causes pneumococcal disease. Pneumococcal infections can range from ear and sinus infections to pneumonia and bloodstream infections.

Children younger than 2 years old and adults 65 years or older are among those most at risk for the disease. There are vaccines to prevent pneumococcal disease in children and adults, says the CDC.

Merck is a leading global biopharmaceutical company known as MSD outside of the United States and Canada. For more information, visit Merck.

Sub Title:

Merck’s V114 pneumococcal conjugate vaccine receives FDA Breakthrough Therapy Designation

References:

Merck Receives Breakthrough Therapy Designation from FDA for V114, the Company’s Investigational 15-Valent Conjugate Vaccine

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine

Global Pneumococcal Disease and Vaccine

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Monday, July 19, 2021 - 06:15

Phase 3 Studies on PCV-15 Launched

Don Hackett — Wed, 18 Apr 2018 11:34:43 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

While most people have heard of pneumonia, many are confused who pneumococcal disease impacts.

Each year in the United States, pneumococcal disease kills thousands of adults, including 16,000 adults aged 65+ years.

Pneumococcal disease is an infection caused by Streptococcus Pneumoniae bacteria, sometimes referred to as pneumococcus.

Pneumococcus can cause many types of illnesses, including pneumonia, ear infections and meningitis, reports the Centers for Disease Control and Prevention (CDC).

The best way to prevent pneumococcal disease is to get an approved vaccine(s).

There are 2 types of approved pneumococcal vaccines:

The PCV13 vaccine for infants, older adults, and people with certain health conditions,
The PPSV23 vaccine for children and adults age 2 and older, older adults, people with certain health conditions, and adults ages 19 through 64 who smoke.

And, Merck, the manufacturer of these vaccines, is beginning two Phase 3 studies of PCV-15 (V114), its investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease.

**** Find a clinical trial in 60 seconds ****

The decision to move PCV-15 to Phase 3 studies is based on the findings of previous Phase 1 and Phase 2 studies, the results of which are being presented at the upcoming International Society on Pneumococci and Pneumococcal Diseases conference.

The first Phase 3 study (NCT03480763) will evaluate the safety, tolerability, and immunogenicity of PCV-15 followed by Pneumococcal Vaccine Polyvalent 1 year later in healthy adult subjects 50 years of age or older.

The second Phase 3 study (NCT03480802) is evaluating the safety, tolerability and immunogenicity of PCV-15 followed by Pneumococcal Vaccine Polyvalent administered 8 weeks later in adults infected with human immunodeficiency virus (HIV).

These advanced studies are focused on expanding the use of the PCV-15 vaccine, which is needed research.

But, previous research found getting pneumococcal vaccines prescribed is also an issue.

A study in 2017 indicated that primary care providers and physician assistants often fail to encourage vaccination against pneumococcus in patients who had asthma or were active smokers.

But, pharmacists embedded in family practice clinics were most likely to vaccinate patients. The pharmacists who participated in this study were able to spend more time with patients as they manage chronic conditions.

The CDC recommends these vaccines for all adults 65 years or older.

It is also recommended for children and adults 2 through 64 years old who are at increased risk for pneumococcal disease.

Because there are more than 90 known pneumococcal serotypes that cause disease, a previous pneumococcal infection will not protect you from a future infection.

Therefore, the CDC recommends pneumococcal vaccines for both children and adults who have had the pneumococcal disease in the past.

Most government and private health insurance policies cover pneumococcal vaccines.

The CDC Vaccine Price List provides private sector vaccine prices for general information. Vaccine discount information in the USA can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

Sub Title:

To prevent pneumococcal disease, get vaccinated

References:

A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003 AM2)

Merck Announces First Phase Three Studies for PCV-15 (V114) Its Investigational Pneumococcal Disease Vaccine

Immunogenicity differences of a 15-valent pneumococcal polysaccharide conjugate vaccine (PCV15) based on vaccine dose, route of

The Pneumocell-study: Vaccination of IgG1- and IgG2-deficient patients with Prevnar13

Evaluation of a 15-valent Pneumococcal Conjugate Vaccine in an Adult Rhesus Macaque Immunogenicity Model