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Pneumococcal Conjugate Vaccine Candidate Found Effective for Adults

June 21, 2022 • 7:32 am CDT
by Barbara Jackson
(Precision Vaccinations)

New Jersey-based Merck announced today the presentation of positive results from the Phase 1/2 study, V116-001, evaluating the safety, tolerability, and immunogenicity of V116, the company's investigational 21-valent pneumococcal conjugate vaccine (PCV).

On June 21, 2022, Merck stated in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2), V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX®23 across age groups.

In the Phase 2 part of the study, V116 demonstrated non-inferior immune responses to PNEUMOVAX 23 for all shared serotypes and superior immune responses for the serotypes included in V116 but not included in PNEUMOVAX 23, based on study-defined criteria.

"Our encouraging data at ISPPD reflect the potential of V116 and Merck's tailored approach to developing pneumococcal vaccines to meet the specific needs of different populations," said Dr. Eliav Barr, SVP, head of global clinical development and chief medical officer, Merck Research Laboratories, in a related press release.

"Consistent with our portfolio strategy, V116 is designed to specifically target serotypes responsible for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the USA."

"Importantly, the eight serotypes in V116 that are not included in any currently-licensed pneumococcal vaccine account for over 30% of this disease burden alone."

Earlier this year, V116 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B.

Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae or pneumococcus.

Invasive forms of the pneumococcal disease can cause serious and potentially life-threatening infections such as bacteremia and meningitis.

Pneumonia (infection in the lungs), with or without bacteremia, also can occur.

Additional pneumococcal vaccine news is posted at PrecisionVaccinations.

Note: This Merck announcement was manually curated for mobile readers.