A simplified schedule to integrate the hepatitis B vaccine into an expanded program of immunization in endemic countries.
OBJECTIVE
To investigate the safety, immunogenicity, and efficacy of a simplified hepatitis B vaccination schedule.


METHODS
The second dose of hepatitis B vaccine and the first dose of diphtheria-tetanus-pertussis (DTP) vaccine were given simultaneously at age 6 weeks. The second dose of DTP vaccine was given at age 3.5 months. The third dose of DTP vaccine and the third dose of hepatitis B vaccine were given at age 5.5 months. One hundred three infants (group A) born to mothers without hepatitis B surface antigen (HBsAg) received DTP with whole-cell pertussis vaccine. Fifty-five infants (group B) born to mothers with HBsAg and hepatitis B e antigen received DTP with acellular pertussis vaccine.


RESULTS
By age 9 months, none of group A and 4 (7%) group B infants were sero-positive for HBsAg. The protective efficacy against the hepatitis B carrier state in these infants at high risk was 92%. Antibody to hepatitis B surface antigen was 10 mlU/ml or greater in 99 (96%) of group A infants and in 50 (91%) of group B infants. Both the acellular and whole-cell DTP vaccines were immunogenic, and the incidences of adverse reactions were within an expected and acceptable range.


CONCLUSIONS
The simplified vaccination schedule to integrate the hepatitis B vaccine into the Expanded Programme of Immunization was safe, Immunogenic, and effective. This schedule may improve vaccine compliance and be applied to DTP and hepatitis B combination vaccines now under investigation.
Lee
C Y
CY
Department of Pediatrics, National Taiwan University Hospital, Taipel, Republic of China.
Lee
P I
PI
Huang
L M
LM
Chen
J M
JM
Chang
M H
MH
D000941:Antigens / Q000097:blood; D004165:Diphtheria / Q000517:prevention & control; D004166:Diphtheria Antitoxin / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects / Q000627:therapeutic use; D019353:Endemic Diseases; D006388:Hemagglutinins / Q000097:blood; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007231:Infant, Newborn; D013742:Tetanus / Q000517:prevention & control; D013743:Tetanus Antitoxin / Q000097:blood; D010566:Virulence Factors, Bordetella; D014917:Whooping Cough / Q000517:prevention & control
D000941:Antigens; D004166:Diphtheria Antitoxin; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D006388:Hemagglutinins; D017325:Hepatitis B Vaccines; D013743:Tetanus Antitoxin; D010566:Virulence Factors, Bordetella