Immunogenicity, reactogenicity and safety of three-dose primary and booster vaccination with combined diphtheria-tetanus-whole-cell pertussis-hepatitis B-reduced antigen content Haemophilus influenzae type b vaccine in Filipino children.

Abstract

OBJECTIVES:

To evaluate the immunogenicity, reactogenicity and safety of primary and booster vaccination with DTPw-HBVLT/Hib2.5 vaccine containing low thiomersal and reduced quantities of Hib polysaccharide (PRP).

BACKGROUND:

Combined DTP vaccines have high global coverage. Thus, the addition of new antigens to existing DTP vaccines is the most effective way to ensure high coverage.

METHODS:

192 healthy infants were randomized to receive the investigational DTPw-HBVLT/Hib2.5 vaccine or licensed DTPw-HBV/Hib10 at 6, 10, 14 weeks. Immune memory to the Hib antigen was assessed through administration of plain PRP challenge at 10 months in 50% of subjects. Challenged and unchallenged subjects respectively received a DTP-HBV or DTPa-HBV/Hib booster at 15-18 months of age. Antibody responses were measured using enzyme-linked immunosorbent assay (ELISA) and reactogenicity was assessed using diary cards.

RESULTS:

One month post-primary vaccination, 100% and ≥ 93.7% of subjects in both groups had anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL, respectively. Robust responses to PRP were observed after the 10 month plain PRP challenge and booster responses were observed in unchallenged subjects after the booster dose at 15-18 months of age. Post-primary and post-booster responses to the other vaccine antigens were at least as high in the DTPw-HBVLT/Hib2.5 group versus the DTPw-HBV/Hib10 group. The reactogenicity profile of the DTPw-HBVLT/Hib2.5 vaccine was acceptable.

CONCLUSION:

The DTPw-HBVLT/Hib2.5 combination vaccine with reduced thiomersal and Hib content had equivalent immunogenicity and tolerability versus the full standard DTPw-HBV/Hib10 vaccine. DTPw-HBVLT/Hib2.5 or DTPw-HBV/Hib10 vaccines can contribute to reducing childhood diseases through ensuring high vaccine coverage in mass vaccination programs. ClinicalTrials.gov identifiers: NCT 01061541, NCT00158808.

• Authors: Salvacion R Gatchalian, Gunasekaran Ramakrishnan, Hans L Bock, Inge Lefevre, Jeanne M Jacquet
• Journal: Human vaccines (Hum Vaccin) Vol. 6 Issue 8 Pg. 664-72 (Aug 2010) ISSN: 1554-8619 [Electronic] United States
• PMID: 20657177 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Antibodies, Viral
• Diphtheria-Tetanus-Pertussis Vaccine
• Haemophilus Vaccines
• Hepatitis B Antigens
• Hepatitis B Vaccines
• Vaccines, Combined
• diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine

Topics

• Antibodies, Bacterial (blood)
• Antibodies, Viral (blood)
• Diphtheria (prevention & control)
• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage, adverse effects, immunology)
• Enzyme-Linked Immunosorbent Assay
• Haemophilus Infections (prevention & control)
• Haemophilus Vaccines (administration & dosage, adverse effects, immunology)
• Haemophilus influenzae type b (immunology)
• Hepatitis B (prevention & control)
• Hepatitis B Antigens (immunology)
• Hepatitis B Vaccines (administration & dosage, adverse effects, immunology)
• Humans
• Immunization Schedule
• Immunization, Secondary
• Philippines
• Tetanus (prevention & control)
• Treatment Outcome
• Vaccination
• Vaccines, Combined (administration & dosage, adverse effects, immunology)
• Whooping Cough (prevention & control)