The immunogenicity and safety of Haemophilus influenzae type b-tetanus toxoid conjugate vaccine in Gambian infants.
In developing countries, Haemophilus influenzae type b is a major cause of meningitis and pneumonia in the 1st year of life. The safety and immunogenicity of a Haemophilus influenzae type b polysaccharide-tetanus toxoid conjugate vaccine (PRP-T) were evaluated in two studies of Gambian infants. In the first study, 131 infants were recruited and randomized into three groups to receive PRP-T at 1 and 3 months (group A), PRP-T at 2 and 4 months (group B) or no PRP-T (group C). The liquid form of PRP-T was used. The geometric mean titre (GMT) of anti-PRP antibody 1 month after the second dose was 0.26 microgram/ml in group A and 0.41 microgram/ml in group B. In the second study, 66 infants were given PRP-T in the lyophilized form at 2, 3 and 4 months of age. The GMT 1 month after the first dose was 0.09 microgram/ml, after the second 0.74 microgram/ml and after the third 2.32 micrograms/ml. After the third dose, 72% of children had antibody levels greater than 1.0 microgram/ml and 93% greater than 0.15 microgram/ml. No serious side-effects were observed and the rate of adverse reactions was consistent with the concurrent administration of diphtheria-tetanus-pertussis (DPT) vaccine.
Mulholland
E K
EK
Medical Research Council Laboratories, Banjul, The Gambia.
Byass
P
P
Campbell
H
H
Fritzell
B
B
Greenwood
A M
AM
Todd
J
J
Greenwood
B M
BM
D000367:Age Factors; D000907:Antibodies, Bacterial / Q000097:blood*; D005612:Freeze Drying; D005714:Gambia; D018073:Haemophilus Vaccines / Q000009:adverse effects / Q000276:immunology*; D006193:Haemophilus influenzae / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007231:Infant, Newborn; D013745:Tetanus Toxoid / Q000009:adverse effects / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology*
D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate