Prevenar13

Eleven healthy volunteers were recruited upon informed and written consent. Two subjects had previously been vaccinated with pneumococcal vaccines (Table 2). Eight subjects received a single dose of a 13-valent conjugate pneumococcal vaccine (Prevenar 13, PCV13, Pfizer) and three subjects received a single dose of a 23-valent unconjugated pneumococcal polysaccharide vaccine (Pneumovax 23, PPV23, MSD). Serum and blood from venous blood were taken before, 2 weeks and 2 months after vaccination. Pneumococcal serotype-specific IgG concentrations were analyzed as described above. Opsonophagocytic killing was assessed using the hirudin assays described above inoculated with a bacterial dilution containing 7.3 ± 3.1 x 10³ CFU/mL.

At inclusion, a blood sample was collected for all patients before vaccination (M0), then a single 0.5 ml intramuscular injection of PCV13 (Prevenar13^®; Pfizer) was administered according to French guidelines.
The patients continued routine HIV care and were followed for up to one year without injection of further pneumococcal polysaccharide vaccine. Blood samples for immunological assessment were collected at baseline (M0) and during follow-up at 1- (M1), 6- (M6), and 12 months (M12).
Sociodemographic characteristics, clinical data, and blood test results were collected at baseline using a dedicated case report form. HIV viral load and CD4 cell count were collected at baseline, and then at 1-, 6-, and 12- months when available.

Participants received one dose of PCV13, followed by one dose of PPSV23, with a 2-month interval. PCV13 or Prevenar 13^® (Pfizer, New York, NY, USA) includes purified capsular polysaccharide of 13 serotypes of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F) conjugated to a nontoxic variant of diphtheria toxin known as CRM197. PPSV23 or Pneumovax 23^® (Merck Sharp & Dohme, Kenilworth, NJ, USA) contains purified capsular polysaccharide of 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). Some participants concomitantly received other recommended vaccinations, such as hepatitis B, influenza, or travel vaccines. All vaccines were administered intramuscularly. Prior to the first vaccination (T0), baseline clinical and demographical data were collected. Serum samples were collected at baseline and at 2, 4, 6, and 12 months after enrollment, and were frozen at −80 °C until further analysis. Serotype-specific pneumococcal IgG serum concentrations were measured using a 26-plex multiplex immunoassay as described previously [16 (link)]. After each vaccination, participants were asked to record adverse events (AEs) through an online questionnaire. Serious adverse events (SAEs) were recorded throughout the study period.

In this study, the injected vaccines were 13-valent pneumococcal conjugate vaccine (PCV13; Prevenar 13™; Pfizer, NY, USA) and DTPa-IPV/Hib (diphtheria toxoid, tetanus toxoid, acellular pertussis, polio, and Haemophilus influenzae type b; Pediacel™; Sanofi Pasteur, Lyon, France). The injection procedure, including skin cleaning, injection location, injection pressure, and total injection time, was standardized for all vaccinations to maintain consistency. For skin cleaning, they applied 70% alcohol-based solution on a single-use swab and allowed it to dry completely before injection. The clinical nurses administered DTPa-IPV/Hib in right thighs and then PCV13 in alternate thighs [25 (link)]. Each vaccine was administered into the vastus lateralis muscle on the front of the thigh. The injection was rapid. Aspiration was done before pushing the syringe because this is a part of nursing guideline to avoid intravenous injection. Five nurses in charge of injection were trained and accredited by practicing the procedure at least three times before the study commenced. All nurses trained for the study have given injections for at least 3 years of clinical experience in vaccine injection. All five nurses were equally split between groups. After vaccination, manual stimulation of the injection site was not allowed.

At inclusion, patients received one single 0.5 ml intramuscular dose of 13-valent anti-pneumococcal conjugate vaccine (PCV13, Prevenar13^®; Pfizer) following a routine visit. The vaccine contained polysaccharides from the pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to a nontoxic diphtheria toxin cross-reactive material CRM197 protein. Blood-samples were obtained at baseline and one, six and twelve months after vaccination. Each blood sample was drawn before each infusion of immunoglobulin replacement therapy for patients undergoing such treatment.

In line with UK vaccine policy, vaccinated women received tetanus, diphtheria and pertussis‐containing vaccines (Tdap); Repevax^® (Sanofi Pasteur, Lyon, France; prior to July 2014) or Boostrix‐IPV^® (GlaxoSmithKline, Wavre, Belgium; after July 2014). As per routine vaccination schedules in the United Kingdom, infants received three doses of tetanus, diphtheria and pertussis‐containing vaccine at 8, 12 and 16 weeks; DtaP5‐IPV‐Hib (Pediacel^®; Sanofi Pasteur) or DtaP3‐IPV‐Hib (Infanrix‐IPV‐Hib^®; GlaxoSmithKline). All infants received two doses of 13‐valent conjugate pneumococcal polysaccharide vaccine, Prevenar13^® (Pfizer, Puurs, Belgium) at 8 and 16 weeks.