Antibody persistence in pre-school children after hexavalent vaccine infant primary and booster administration

ABSTRACT

Objective: Antibody persistence evaluation for all antigens of a fully liquid DTaP-IPV-HB-PRP~T vaccine at 3.5 and 4.5 y of age following different primary series and booster schedules in South Africa and Latin America.

Methods: Participants had completed one of two previous studies (Study 1-South Africa; Study 2-Latin America). In Study 1, participants who had not received HB vaccine at birth received a 6–10-14 week primary series of DTaP-IPV-HB-PRP~T or DTwP/PRP~T-Hib+HB+OPV and a third group who had received HB vaccine at birth received a 6–10-14 week primary series of DTaP-IPV-HB-PRP~T; all received a booster (15–18 months) of the primary series vaccine(s) except for HB in the DTwP/PRP~T-Hib group. In Study 2, participants received HB vaccine at birth, a 2–4-6 month primary series of DTaP-IPV-HB-PRP~T or DTaP-HB-IPV//PRP~T, and a DTaP-IPV-HB-PRP~T or DTaP-HB-IPV//PRP~T booster (12–24 months). Participants were followed up at 3.5 and 4.5 y of age for antibody persistence.

Results: Approximately 80% of eligible participants were assessed. In Study 1, a birth dose of HB increased anti-HBs persistence (≥10 mIU/mL) following DTaP-IPV-HB-PRP~T primary and booster vaccination from 76.3% to 96.1% at 3.5 y of age and from 73.3% to 96.1% at 4.5 y of age; in Study 2, anti-HBs persistence was high and similar in each group. For the other antigens, there were no differences between groups or studies at 3.5 or 4.5 y.

Conclusion: Good persistence of antibodies to each antigen in the DTaP-IPV-HB-PRP~T vaccine up to pre-school age, irrespective of the vaccination schedule during the first 2 y of life.

Keywords:

• fully liquid
• hexavalent
• immunity persistence
• infant
• primary series
• booster
• vaccine

Acknowledgments

The authors acknowledge all enrolled infants and parents/legal guardian(s) for their participation.

The authors would also like to thank the co-investigators for the primary series and booster studies in South Africa (Ismail Mitha MD, Anthonet Koen MD, Clare Cutland MD, and Michelle Groome MD) and Costa Rica (Adriano Arguedas Mohs MD, Arturo Abdelnour Vásquez MD) and all study personnel for the conduct of the studies.

At Sanofi Pasteur, the authors thank Fabrice Bailleux, Xavier DaCosta, Séverine Paulhac, Eduardo Santos-Lima, Maria Consuelo Miranda, and the Hexaxim clinical team for their valuable input into the conception, execution, and analysis of the clinical trials described in this manuscript.

This manuscript was prepared with the assistance of a professional medical writer, Dr Andrew Lane (Lane Medical Writing) funded by Sanofi Pasteur, in accordance with the European Medical Writers Association guidelines and Good Publication Practice.

Authors Contributions

SM, SB’C, EJ, and EF contributed to the conception, design, and clinical conduct of Study 1.

PL, BZ, SB’C, EJ, and FN contributed to the conception, design, and clinical conduct of Study 2.

All authors contributed to the analysis and interpretation of study data presented in this article and all approved the final version of this article.

Disclosure of potential conflicts of interest

No clinical investigator (SM and PL) involved in these studies received any direct payment from Sanofi Pasteur with regard to their contribution to this manuscript, but received funding for their institutions from Sanofi Pasteur to support their work in their respective studies and could receive expenses for conference attendance for the presentation of data from these studies.

BZ, EJ, SB’C, FN, and EF are employees of Sanofi Pasteur.

Additional information

Funding

This study was supported by Sanofi Pasteur, Lyon, France.