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Highlights from

The European Congress of Clinical Microbiology & Infectious Diseases

29th Annual Meeting

Amsterdam 13-16 April 2019

Promising phase II results for pneumococcal vaccine in 60-64 year olds

Take-home messages
  • PCVs have an established track record of preventing pneumococcal disease
  • PCV20 was designed to protect against 20 serotypes of pneumococcal disease
  • In a phase II trial, PCV20 elicited substantial antibody responses to all 20 serotypes, was well tolerated and had an adverse-event profile consistent with established PCVs in 60-64 year old patients
“PCV20 was well tolerated in adults 60 through 64 years of age. The AE profile was consistent with the historical experience of PCVs in this age group.”

Dr Wendy Watson, Senior Director of Vaccines, Clinical Research, Pfizer, Philadelphia, US

The 20-valent pneumococcal conjugate vaccine (PCV20) was well tolerated and had an AE (adverse-event) profile consistent with known PCVs in adults aged 60-64 in phase II trials. Furthermore, PCV20 elicited substantial antibody responses to all 20 serotypes. Dr Wendy Watson, Senior Director of Vaccines, Clinical Research, Pfizer, Philadelphia, US, presented the results at this year’s European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2019, Amsterdam, the Netherlands.

In the UK, there are currently two licensed pneumococcal vaccines:

  • PCV13 (Prevenar®), a 13-valent PCV for babies and children aged 6 weeks to 17 years
  • 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax®), a pneumococcal polysaccharide vaccine for people aged 2 years and over

These vaccines have contributed to a major reduction in pneumococcal disease worldwide, however there is an unmet need as a result of some serotypes not being included in PCV13. PCV20 aims to protect patients against 20 serotypes. It is hoped that the PCV20 vaccine will help prevent against invasive disease and pneumonia in adults aged 18 and older.

Pneumococcal disease is caused by the gram-positive bacterium Streptococcus pneumoniae. Invasive pneumococcal disease may be life threatening and lead to bacteraemia, sepsis, meningitis and pneumonia.

Pneumococcal infections affect people of all ages but children <2 years old and adults aged 65 years and older are at higher risk.

In this randomised, active-controlled, double-blinded trial, adults aged 60 to 64 received a single dose of PCV20 (n=222) or PCV13 (n=222), Vaccination 1 of the trial. Patient demographics were similar between groups (56% were female and 44% were male). Median age was 62 years. 75.4% were white; 18.7% were African American and 3.4% were Asian.

One month after Vaccination 1, PCV20 recipients were given saline placebo and PCV13 recipients were given PPSV23 (Vaccination 2). 444 people received Vaccination 1 and 427 received Vaccination 2.

The researchers recorded local reactions for 10 days and systemic events for 7 days after Vaccination 1; AE data were collected for 1 month after each vaccination. Immunogenicity was assessed by measuring serotype-specific opsonophagocytic activity (OPA) titres prior to vaccination and 1 month after each vaccination.

PCV20 elicited substantial increases in OPA titres to all PCV20 serotypes. In the PCV20 group, OPA geometric mean fold-rises from baseline ranged from 6.1 to 57.4 for the serotypes in common with PCV13, and 11 to 112.2 for the seven additional serotypes.

Injection site reactions (redness, swelling or pain) and systemic event rates were similar after vaccination with PCV20 or PCV13.

Severe injection site reactions or severe systemic events were reported in less than 1% of PCV20 recipients. No deaths or serious AEs considered related to vaccine were reported in the study, and no safety concerns were noted.

Due to these positive data, phase III trials have now been initiated for PCV20, which has received Breakthrough Therapy Designation by the FDA (Food and Drug Administration). At the same time, a new 15-valent pneumococcal vaccine, V114, has also begun phase III trials and been granted FDA Breakthrough Therapy Designation.

Based on Watson, W, Hurley D et al. Safety, tolerability, and immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 60-64 years of age (oral presentation O0087). Presented on Saturday 14 April 2019.

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The content and interpretation of these conference highlights are the views and comments of the speakers/ authors.

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