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Table 4 Studies concerning the immunogenicity of hexavalent vaccination in preterm

From: Hexavalent vaccines in preterm infants: an update by Italian Society of Pediatric Allergy and Immunology jointly with the Italian Society of Neonatology

Author (year)

Study

Number of children

Gestational age (EG) in weeks (s)

Sed

Vaccine

Target

Results

Bias

Vermeulen et al. (2013)

Prospective cohort observation

68

• 22 immunized with vaccine cellulare (Pw)

• 24 immunized with 2-component acelular vaccine (Pa-2)

• 22 immunized with 3-component acelular vaccine (Pa-3)

< 31 s

Belgium

3 types: Pw, Pa-2, Pa-3

Evaluate the 1-year specific cellular response in the preterm by cytokine secretion after antigenic stimulation

• More than half of the preterm vaccinated with Pw or Pa-2 develops a response at 3 and 6 months

• IFNɤ to FHA and PT

• No effect of the booster dose on FHA or PTinduced IFNzione secretion in the 3 groups

• The Pa vaccine induces a greater secretion of Th2 cytokines in response to FHA and PT, compared to children vaccinated with Pw

Limited sample

Omeñaca et al. (2011)

Prospective

286

• Group I: 27–30 s

• Group II: 31–36 s

• Group III: ≥ 37 s

Spain, Greece

PHiD-CV Co-administration DTPa, IPV, HBV, Hib, PCV

Evaluate the immunogenicity of PHiD-CV at 2, 4, 6 months by evaluating the antibody titre as OPA or GMC 1 month after the primary vaccy cycle and 1 month after the booster dose

One month after the primary vaccination cycle and the booster dose, all bambinii serum were protected against the antigens of vaccini coadministered

 

Omeñaca et al. (2011)

Phase IIIb perspective, controlled, multicentric

309

• 56 group I: ≤ 31 s

• 107 group II: 32–36 s

• 150 group III: ≥ 37 s

Spain

Hib-MenC-TT to 2, 4, 6 months and 16–18 months

Co-administration DTPa, IPV, HBV, Hib, PCV, rotavirus

Evaluate the immunogenicityof Hib-MenC-TT in preterm by measuring the specific antibody titer 1 month after the third dose and 1 month after the booster dose

• The percentage of subjects with a concentration of anti-PRP antibodies compatible with seroprotection is ≥99% in all groups

• The booster dose induces a marked increase in anti-PRP GCM, after a reduction in the percentage of subjects with seroprotective titres before the booster dose

• At least 97.5% of the subjects in each group have concentrations of anti-H Bs antibodies > 10 mIU / mL at 1 month after the third vaccination dose

• The titer of anti-HBV antibodies after dose 3 is significantly lower in preterm than group I compared to those born with larger EGs

 

Klein et al. (2010)

Observational perspective

88

33 ≤ 33 s

50 ≥ 37 s

≤ 31.3–39.5 s

United States of America

DTPa, IPV, HBV, Hib

PCV co-administration

Compare the humoral and cellular response of preterm vs full term babies after the primary vaccination cycle

• Preterms and those born at term develop comparable levels of memory response of T cells to type 3 polioviruses

• With regard to lympho-monocellular proliferation

Preterms present less frequently a positive stimulation index compared to those born at term (p = 0.03)

• All subjects have serumprotective antibody titers for the 3 types of poliovirus

• The GMC towards the sierotipo 1 polio was significantly lower in pretermiit compared to those born to ter mines

 

Omeñaca et al. (2010)

Prospective trial

182

93 < 37 s

89 ≥ 37 s

Spain

DTPa, IPV, HBV, Hib

Evaluate the response to hepatitis B vaccine in preterm after the primary vaccination cycle and the booster dose

• 93.4 and 95.2% of preterm and full-term babies respectively show seroprotection against HBV after the primary vaccination cycle

• The GMCs for HBV after primary cycle are lower in the Group of preterm born than in the group of term births, although not in a statistically significant manner

• 6 preterm (6.59%) respond neither to the primary cycle nor to the booster dose

• Non-responders have an EG ≤ 31 s of which 2 are severe IUGR

 
  1. DTaP Diphtheria, tetanus, acellular pertussis, IPV Polio inactivated vaccine, HBV Hepatitis B vaccine, PCV7 Heptavalent pneumococcal vaccine, PCV13 Pneumatic anti-pneumococcal vaccine, Hib H. influenzae type b vaccine, Hib-MenC-TT Vaccine for H. influenzae type B-Neisseria meningitidis serogroup of type C, PHID-CV Decavalent pneumococcal vaccine (PCV10) conjugated to the protein
  2. D diH Non-typable influenzae, SNAP-II Score for Neonatal Acute Physiology II, PT Pertussis toxin, FHA Phytohemagglutinin, OPA Opsonophagocytic activity, GMCs Geometric mean concentration, PRP Antipoliribosilribitolfosate