Immunogenicity and safety of a DTaP-IPV//PRP approximately T combination vaccine given with hepatitis B vaccine: a randomized open-label trial.

Abstract

OBJECTIVE:

To determine seroprotection and vaccine response rates produced by a diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type-b conjugate (DTaP-IPV//PRP approximately T) vaccine containing a polyribosyl-ribitol-phosphate (PRP)-tetanus toxoid conjugate (Pentaxim) and given with a hepatitis B vaccine.

METHODS:

In this multicentre open-label trial, 424 infants who received DTaP-IPV//PRP approximately T at 6, 10 and 14 weeks of age were also randomized to receive hepatitis B vaccine at either 6, 10 and 14 weeks or 0, 6 and 14 weeks of age. Antibody levels were determined at 6 and 18 weeks of age, and reactogenicity was monitored using parental reports.

FINDINGS:

Immunogenicity was high for all vaccine antigens and was similar to that in a historical control study. After primary vaccination, 98.7% of all infants had an anti-PRP antibody titre > 0.15 microg/ml. Seroprotection against poliovirus type-1, -2 and -3 and tetanus was obtained in all infants, and against diphtheria, in 97.1%. Pertussis seroconversion, defined as a > fourfold increase in antibody titre, occurred in 95.3% for anti-pertussis toxoid antibody and in 89.0% for anti-filamentous haemagglutinin antibody. The hepatitis B seroprotection rate was 99.5% with administration at 0, 6 and 14 weeks, and 97.8%, at 6, 10 and 14 weeks. However, the antibody titre was higher with the 0, 6 and 14-week schedule (601 mIU/ml versus 207 mIU/ml). The reactogenicity of both vaccines was low.

CONCLUSION:

The DTaP-IPV//PRP approximately T vaccine was highly immunogenic. The anti-hepatitis B antibody response was seroprotective with both schedules, though the antibody titre was higher with the 0, 6 and 14-week schedule.

• Authors: Maria Rosario Capeding, Josefina Cadorna-Carlos, May Book-Montellano, Esteban Ortiz
• Journal: Bulletin of the World Health Organization (Bull World Health Organ) Vol. 86 Issue 6 Pg. 443-51 (Jun 2008) ISSN: 1564-0604 [Electronic] Switzerland
• PMID: 18568273 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• DTPa-HBV-IPV combined vaccine
• Diphtheria-Tetanus-Pertussis Vaccine
• Haemophilus Vaccines
• Hepatitis B Antibodies
• Hepatitis B Vaccines
• Poliovirus Vaccine, Inactivated
• Polysaccharides
• Vaccines, Combined
• polyribitol phosphate

Topics

• Antibody Formation (drug effects)
• Diphtheria-Tetanus-Pertussis Vaccine
• Female
• Haemophilus Vaccines
• Hepatitis B (drug therapy, genetics, immunology, virology)
• Hepatitis B Antibodies (drug effects)
• Hepatitis B Vaccines (administration & dosage, adverse effects, immunology)
• Humans
• Infant
• Male
• Philippines
• Poliovirus Vaccine, Inactivated
• Polysaccharides (therapeutic use)
• Vaccines, Combined (administration & dosage, adverse effects, immunology, therapeutic use)